[ { "term": "Common Errors", "definition": "ClinicalTrials.gov \u201cBasic Results\u201d Database 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DRAFT", "definition": "60 60 \u2022 Report two different tables \u2013 Serious and Other \u2013 Do not report any serious adverse events in the Other Adverse", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Results Database", "definition": "\u2022 Submitted data are used to develop basic tables for the public display \u2022 Tables must be interpretable by people not familiar with each particular study \u2022 Labels for rows, columns, and units of measure must be meaningful and precise 2 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Measure Type", "definition": "\u2022 In general, spell out symbols such as \u2013 \u201cPercentage\u201d rather than \u201c%\u201d \u2013 \u201cNumber\u201d rather than \u201cNo.\u201d or \u201c#\u201d \u2022 Use decimal points (not commas) for the \u201cdecimal separator\u201d and commas (not periods) for the \u201cthousands separator\u201d 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Participant Flow", "definition": "\u2022 Number STARTED should be consistent with \u201cEnrollment, Actual\u201d in protocol section \u2013 Correct \u201cEnrollment, Actual\u201d (or explain inconsistencies in Pre- Assignment Details) \u2022 If more than one Period, number COMPLETED for each Period should equal number STARTED for next Period (or explain loss or addition of participants) \u2022 If \u201cMilestones\u201d are defined, number for each \u201cMilestone\u201d", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "must be", "definition": "\u2013 Less than or equal to number STARTED Period (or number that achieved previous Milestone) \u2013 Greater than or equal to number COMPLETED Period (or number that achieved subsequent Milestone) 7 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "June 2006", "definition": "Study Completion Date: October 2007 Primary Completion Date: October 2007 (Final data collection date for primary outcome measure) Basic Results Section: Summary Protocol Section:", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NOT COMPLETED", "definition": "0 0 0 0 Participant Flow: Overall Study EXAMPLE: Dose Escalation \u2013 Different Participants Receive Each Dose (Public View) Arms/Groups", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "level cohort", "definition": "[1] [2] [3] [1] Dose level given only after lower dose was successfully administered [2] Dose level given only after lower dose was successfully administered [3] 2 participants were paired with each dose level of Drug X 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "STARTED", "definition": "4 2 Low Dose (5 mg) 4 2 Medium Dose (50 mg) 4 2 High Dose (100 mg) 4 2", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Helpful Hints", "definition": "\u2022 Measure Title \u2022 Specific name of scale \u2022 Spell out acronym, add acronym in parentheses \u2022 Measure Description \u2022 Construct/Domain if not clear from Measure Title \u2022 e.g., pain, quality of life \u2022 Range and direction of scores (e.g., 0 is best; 10 is worst) \u2022 Optional: Type of scale \u2022 e.g., continuous, ordinal \u2022 Unit of Measure \u2022 Use \u201cparticipants,\u201d if applicable (i.e., for categorical data) \u2022 Use \u201cunits on a scale\u201d or \u201cscores on a scale,\u201d if no other units (i.e., for continuous data) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "about these values", "definition": "(e.g., is \u201c0\u201d better or worse than \u201c2\u201d?) Correct: Values within each scale category represent number of \u201cparticipants\u201d", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BEFORE Revision", "definition": "Brief description added to indicate \u201cdirectionality\u201d", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AFTER Revision", "definition": "BEFORE & AFTER Revision (Data Entry View)", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Walking", "definition": "4 3 \u2013 Limited Self-Care, Partly Confined to Bed 0 4 \u2013 Completely Disabled, No", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Self-Care", "definition": "0 AFTER Revision (Public View)", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Baseline Measures", "definition": "Invalid Data in Total Column 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "possible results", "definition": "\u2022 For categories based on continuous measures, provide thresholds when possible \u2013 Especially for 2 categories (i.e., dichotomous measures) 22 How to Define a Category:", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Drug X", "definition": "Number of Participants 100 100 Number of participants improved on nausea scale [units: participants]", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Nausea", "definition": "[units: Improved] 40 70 Need to explain the scale: \u2022 Range \u2022 Directionality \u201cImproved\u201d is not a", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "measurable unit", "definition": "Report both possible outcomes as dichotomous categories: \u201cimproved\u201d and \u201cnot improved\u201d BEFORE Revision (Public View) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "values represent", "definition": "number of participants who \u201cimproved\u201d Specified: \u2022 Range (1-10) \u2022 Directionality (1 = severe) \u2022 Algorithm (score at 8", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "score and defined", "definition": "\u201cimproved\u201d as greater than a 3-point difference) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Measure Name", "definition": "Assessment of Safety of 10 Dose Levels of Drug X Following 5 Cycles, Consisting of a 2- Week Exposure Period Followed by a 1-Week Rest Period, as Measured by Severe Toxicity and Disease Progression", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Measure Description", "definition": "MTD, as measured by unacceptable toxicity, is exceeded if >33% participants experienced Dose Limiting Toxicities (DLT)", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data", "definition": "AFTER Revision (Public View) Outcome Measure Name and", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "No", "definition": "Secondary Outcome Measure: Use of Community Health Resources", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "High Dose", "definition": "Number of Participants Analyzed 35 34 Frequency and Magnitude of Antibody Response [units: participants] 17 21 May mean \u201cthree-fold or greater increase\u201d BEFORE Revision (Public View)", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Updated Time Frame", "definition": "31 31 Secondary Outcome Measure: Pain Assessment by Patient", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Time Frame", "definition": "Any time during 5 cycles and 30 days", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Measured Values", "definition": "BEFORE Revision (Public View) Reported Statistical Test not directly related to reported Outcome Measure Additional details about the analysis, such as null hypothesis and power calculation: [1] [2] [1] Effect onset is defined as half the time between initial assessment time indicating statistical significance and the previous assessment time. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold of significance: [2] 2-sided statistical tests at 0.05 significance level [3] 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "needs to be numerical", "definition": "(cannot include \u201c+\u201d) BEFORE Revision (Public View) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "assessment", "definition": "Population Description AFTER Revision (Public View) 36 of the 48 total participants had documented tumor progression by the 36-month assessment. Analysis Population Description describes results at 36 months Created categories for progression-free survival", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Placebo", "definition": "Number of Participants Analyzed 125 120 Visual Analogue Scale (VAS) Pain Assessment at 1.5 Hours [units: scores on a scale] Least Squares Mean \u00b1 Standard Error 0.57 \u00b1 0.08 1.12 \u00b1 0.10 Statistical Analysis 1 for Visual Analogue Scale (VAS) Pain Score at 1.5 Hours 58", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Invalid entry", "definition": "BEFORE Revision (Public View) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Heart Rate at Rest", "definition": "[units: beats per minute] Mean \u00b1 Standard Deviation 72.3 \u00b1 2.7 71.9 \u00b1 3.1 0 \u00b1 0 BEFORE Revision (Public View)", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "provide values for", "definition": "the \u201cmean\u201d and \u201cstandard deviation\u201d", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "consistent", "definition": "\u2022 Cells (data) represent measures or counts derived from participants within arms or groups \u2013 Measure Type (and Measure of Dispersion) needs to be consistent with data being reported \u2013 Unit of Measure must be consistent with values \u2013 Absolute values are preferable to percentages 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Week 10 to 18", "definition": "Number of Participants Analyzed 88 80 Treatment Satisfaction Questionnaire After 18 Weeks of Treatment [units: scores on a scale] Mean \u00b1 Standard Deviation 81 \u00b1 17.46 7.9 \u00b1 12.16 Statistical Analysis 1 for Treatment Satisfaction Questionnaire After 18 Weeks Groups compared (\u201cweek 10\u201d vs. \u201cchange from week 10 to 18\u201d) not a logical t-test Confidence Interval is not meaningful without an Estimation Parameter (e.g., mean difference, hazard ratio) BEFORE Revision (Public View) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Pharmacokinetics", "definition": "[units: weeks] 6 BEFORE Revision (Public View) Not clear how to interpret this", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Outcome Measure table", "definition": "\u2022 Time Frame: 6 Weeks \u2022 Units: Weeks \u2022 Outcome Data: 6", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Control", "definition": "Number of Participants Analyzed 28 27 Hours Per Day of Sleep [units: average hours per day] Mean \u00b1 Standard Deviation 823 \u00b1 92 864 \u00b1 106 Inconsistency between Units of Measure, \u201caverage hours per day,\u201d and Measure Data: value provided is greater than the total number of hours in a day BEFORE Revision (Public View) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Inconsistent units", "definition": "\u2013 should be \u201cPercentage\u201d 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Relapse Rate", "definition": "[units: number of relapses] 86 91 BEFORE Revision (Public View) Incorrect Outcome Measure Title: Units and Measure Data provide values for \u201cnumber of relapses,\u201d not \u201crate\u201d (or a quantity in relation to another unit, e.g., \u201crelapses per unit time\u201d) Alternatively, if Outcome Measure Title and Measure Data provide values for numbers of participants that \u201crelapsed,\u201d then the Units should be \u201cparticipants\u201d 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Information", "definition": "\u2022 Outcome Measure Title, Description \u2013 Name and description of measure must be informative to people not familiar with study \u2013 If categorized, need description of categories \u2013 Use neutral words in Title (e.g., \u201ctreatment response\u201d rather than \u201cimprovement\u201d or \u201cincreased response\u201d) \u2022 Units should directly reflect data in the table \u2022 Viewers of the table should be able to understand what the numbers represent 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Yes", "definition": "Primary Outcome Measure: Maximum Tolerated Dose (MTD)", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Indicates measure is", "definition": "\u201cnumber of alerts\u201d BEFORE Revision (Public View) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Discharge", "definition": "Number of Participants Analyzed 90 86 Use of Community Health Resources [units: participants] 4 9 Indicates 4 participants (of 90 or 4.4%) in the \u201cEarly Discharge\u201d group used the specified level", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "health resources", "definition": "used \u2013 how was it measured? 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "represent measures", "definition": "of \u201cfrequency\u201d and \u201cmagnitude\u201d \u201cParticipants\u201d is not a unit of measure for \u201cfrequency\u201d or \u201cmagnitude\u201d Best to provide both categories for a dichotomous measure: \u2022 < 3x increase \u2022 \u22653x increase Best to provide both categories for a dichotomous measure: \u2022 < 3x increase \u2022 \u22653x increase 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Level 5", "definition": "Number of Participants Analyzed 9 4 9 9 9 Maximum Tolerated Dose (MTD) [units: participants]", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Experienced DLT", "definition": "1 0 3 2 5 Dose Level MTD 0 0 9 0 9 BEFORE Revision (Public View) Mismatch among Measure Name, Description, and Data 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Overall Response Rate", "definition": "0.21 95% Confidence Interval 0.12 to 0.33", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Unevaluable", "definition": "6 Statistical Analysis 1 for Response to Drug X BEFORE Revision (Public View) Outcome Measure reported as categorical data (five categories of \u201cresponse\u201d) but Statistical Analysis provided as dichotomous data (\u201cOverall Response Rate = Number Responded / Total Participants\u201d) Need information on how the 5 categories were \u201ccollapsed\u201d into 2 (i.e., Which of 5 response categories were used in calculating the \u201cOverall Response Rate\u201d?). 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Groups", "definition": "Early Discharge vs. Standard Discharge", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "na", "definition": "4.684 95% Confidence Interval 2.080 to 7.730", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P-Value", "definition": "0.05 Mean Difference (Net) 9 Statistical Analysis 1 for Parental Stress", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Standard Discharge", "definition": "Number of Participants Analyzed 100 100", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Parental Stress", "definition": "[units: points on a Likert scale] Mean \u00b1 Standard Deviation 9.3 \u00b1 1.2 7.8 \u00b1 2.1 Inconsistency between Measure Data and Method of Estimation \u2022 Reported Mean Difference: \u201c9\u201d \u2022 By Inspection: 9.3 \u2013 7.8 = 1.5 BEFORE Revision (Public View) 1-09-09", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Events table", "definition": "\u2013 Note that a single type of Adverse Event Term (e.g., \u201casthma\u201d) may appear in both the Serious and Other tables \u2022 If possible indicate the level of severity to distinguish \u201cserious\u201d from \u201cother\u201d adverse events (e.g., \u201casthma \u2013 mild and moderate\u201d in the Other table; \u201casthma \u2013 severe\u201d in the Serious table) \u2022 If no adverse events occurred, enter \u201c0\u201d for the Total Number Affected data elements \u2013 Do not enter 0 if you do not mean to imply that no adverse events", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "occurred", "definition": "60 How to Report Adverse Events:", "sources": [ "FDAAA_CommonErrors.pdf" ], "source": "FDAAA_CommonErrors.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DRAFT \u2013 Helpful Hints: Basic Results", "definition": "9-28-09 ClinicalTrials.gov \u201cBasic Results\u201d Database", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Scales", "definition": "Outcomes may be evaluated and reported with a specific scale. In order for the measure and the outcome to be easily understood, users should describe the scale in the Outcome Measure Title, Description, and Units of Measure fields (e.g., \u201cMean score on the National Library of Medicine (NLM) Pain Scale\u201d Outcome Measure below). Specific items to describe include the following: \uf0b7 Outcome Measure Title: Name of scale (e.g., mean score on NLM Pain Scale) \uf0b7 Outcome Measure Description: o What the scale measures (e.g., severity of pain) o Range and direction (e.g., 0 is no pain and 20 is severe pain) o Other information as appropriate (e.g., whether the scale is ordinal or continuous). \uf0b7 Units of Measure: expressed as \u201cunits on a scale,\u201d \u201cscores on a scale,\u201d or \u201cpoints on a scale\u201d 3 DRAFT \u2013 Helpful Hints: Basic Results 9-28-09 4 3. STATISTICAL ANALYSES Statistical analyses are tied to a specific Outcome Measure. The system allows for the entry of p-values and/or confidence intervals. There is no limit to the number of analyses that can be entered for a given Outcome Measure (e.g., four statistical analyses are associated with the Primary Outcome Measure on pp. 7-9). If a p- value is entered, the test used must be specified. Similarly, if a confidence interval is entered, the estimated parameter must be specified. Users are encouraged to use the free text boxes to provide more complete explanations of their analyses. 4. ADVERSE EVENTS The Adverse Event module is optional (until Sept 27, 2009). However, if one chooses to use the module, the required data elements must be provided (e.g., pp. 10-11). There are separate tables for Serious Adverse Events, and for Other Adverse Events (based on frequency). The same event(s) involving the same participants should not be listed in both tables. DRAFT \u2013 Parallel Design Example \u2013 Public Display 9-28-09 Parallel Design Example This study has been completed. Information provided by Test Organization Study Type: Interventional Study Design: Randomized, Double Blind (Subject, Investigator, Outcomes Assessor),", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Parallel Assignment", "definition": "Interventions: Drug: Drug A Drug: Drug B Drug: Placebo", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Recruitment Details", "definition": "Key information relevant to the recruitment process for the overall study, such as dates of the recruitment", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and January 2006", "definition": "Pre-Assignment Details Significant events and approaches for the overall study following participant enrollment, but prior to group assignment Participants screened over 3 week period.", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Description", "definition": "Total Number of Participants All participants received the reference test (i.e. the gold standard). Serious Adverse Events Total Number of Participants Total # participants affected/at risk 0/2500", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NOT COMPLETED", "definition": "2 1 3 Lost to Follow-up 1 0 2", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Adverse Event", "definition": "1 1 1 Baseline Characteristics", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Total", "definition": "Number of Participants [units: participants] 50 50 50 150", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Age", "definition": "[units: years] Mean \u00b1 Standard Deviation 57 \u00b1 6", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "years", "definition": "50 50 50 150 >=65 years 0 0 0 0", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Male", "definition": "70 diastolic blood pressure [units: mm Hg] Mean \u00b1 Standard Deviation", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Outcome Measures", "definition": "1. Primary Outcome Measure: Maximum Observed Plasma Concentration (Cmax)", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Measure Name", "definition": "Plasma Decay Half-Life (t1/2) Measure Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Hide Details", "definition": "Population Description Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. Each participant received reference and test drug and is, therefore, included in the analysis population for both the reference and test drug.", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Placebo", "definition": "Total # participants affected/at risk 16/50 4/50 13/50 Gastrointestinal disorders Nausea \u2020 # participants affected/at risk # events 4/50 (8%) 4 2/50 (4%) 2 2/50 (4%) 2 Nervous system disorders Headache \u2020 # participants affected/at risk", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "No", "definition": "22 DRAFT \u2013 Diagnostic Test Accuracy Example \u2013 Public Display 9-28-09", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Time Frame", "definition": "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Other Adverse Events", "definition": "Frequency Threshold Above Which Other Adverse Events are Reported: 5% Total Number of Participants Total # participants affected/at risk 128/2500 Gastrointestinal disorders", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "number of events", "definition": "12/50 (24%) 12 2/50 (4%) 2 11/50 (22%) 11 \u2020 Indicates events were collected by systematic assessment 10 DRAFT \u2013 Parallel Design Example \u2013 Public Display 9-28-09 11", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "More Information", "definition": "Certain Agreements: Principal Investigators (PIs) are NOT employed by the organization sponsoring the study. There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI\u2019s rights to discuss or publish trial results after the trial is completed. 28 DRAFT \u2013 Diagnostic Test Accuracy Example \u2013 Public Display 9-28-09 29 Limitations and Caveats Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data Only the most experienced technologists participated and were asked to read the test results in this study. Results may not be applicable to those centers without technologists with extensive related experience. Results Point of Contact: Name/Title: Dr. Y Organization: Test Coop phone: 123-457-9087 ext 1234 e-mail: abc@xyz.inc U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act DRAFT \u2013 Bioequivalence Study Example \u2013 Public Display 9-28-09 Pharmacokinetic Outcome Measures (Bioequivalence Study) Example This study has been completed. Information provided by Test Organization", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "then Drug A", "definition": "Placebo twice daily in first intervention period and Drug A 25 mg twice daily in second intervention period (after washout period). Drug A First,", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "then Placebo", "definition": "Drug A 25 mg twice daily in first intervention period and Placebo twice daily in second intervention period (after washout period). 12 DRAFT \u2013 Crossover Study Example \u2013 Public Display 9-28-09 Participant Flow for 3 periods Period: First Intervention Placebo First,", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "STARTED", "definition": "65 65 Received at Least One Dose of Drug 65 64", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Withdrawal by Subject", "definition": "0 1 Period: Washout Period of 2 Weeks Placebo First,", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Disease relapse", "definition": "2 1 Period: Second Intervention Placebo First,", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Lost to Follow-up", "definition": "1 0 13 DRAFT \u2013 Crossover Study Example \u2013 Public Display 9-28-09 Baseline Characteristics", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Baseline Measures", "definition": "Total Number of Participants Number of Participants [units: participants] 2600", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "At enrollment", "definition": "138 \u00b1 21.2 Beginning of Placebo treatment 138 \u00b1 18.6 Beginning of Drug A treatment 136 \u00b1 19.7", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "weight", "definition": "[units: kg] Mean \u00b1 Standard Deviation 65 \u00b1 11.2 [1] Measurements were taken at baseline, at beginning of 1st and 2nd intervention periods, and end of 1st and 2nd intervention periods. Yielding baseline measurements for treatment with Placebo and Drug A. 14 DRAFT \u2013 Crossover Study Example \u2013 Public Display 9-28-09", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Drug A", "definition": "Total # participants affected/at risk 5/127 10/127 Gastrointestinal disorders Nausea \u2021 # participants affected/at risk # events 5/127 (3.94%) 7 10/127 (7.87%) 12 \u2021 Indicates events were collected by non-systematic methods. 19 DRAFT \u2013 Crossover Study Example \u2013 Public Display 9-28-09 20", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Two-sided", "definition": "2. Primary Outcome Measure: Change from Baseline in Systolic Blood Pressure at 3", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "period and locations", "definition": "2700 participants were selected from multiple primary care sites across the country and all were healthy at baseline without symptoms of disease. Pre-Assignment Details Significant events and approaches for the overall study following participant enrollment, but prior to group", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "assignment", "definition": "100 participants were excluded because they did not properly observe the required pre-diagnostic test routine.", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocol Violation", "definition": "100 21 DRAFT \u2013 Diagnostic Test Accuracy Example \u2013 Public Display 9-28-09 Baseline Characteristics", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Disease", "definition": "Number of Participants Analyzed [units: Participants] 450 2050 Diagnostic Test Data for Disease Using Threshold B [units: participants] Positive diagnostic test for disease using threshold B 400 150 Negative diagnostic test for disease using threshold B 50 1900 Statistical Analysis 1 for Diagnostic Test Data for Disease Using Threshold B Groups [1] Participants With Disease Sensitivity [2] 0.89 95% Confidence Interval ( 0.84 to 0.95 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 2 for Diagnostic Test Data for Disease Using Threshold B Groups [1] Participants Without Disease Specificity [2] 0.93 95% Confidence Interval ( 0.87 to 0.99 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. 25 DRAFT \u2013 Diagnostic Test Accuracy Example \u2013 Public Display 9-28-09 3. Primary Outcome Measure: Diagnostic Test Data for Disease Using Threshold C", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Without Disease", "definition": "Number of Participants Analyzed [units: Participants] 450 2050 Diagnostic Test Data for Disease Using Threshold C [units: participants] Positive diagnostic test for disease using threshold C 380 125 Negative diagnostic test for disease using threshold C 70 1925 26 DRAFT \u2013 Diagnostic Test Accuracy Example \u2013 Public Display 9-28-09 Statistical Analysis 1 for Diagnostic Test Data for Disease Using Threshold C Groups [1] Participants With Disease Sensitivity [2] 0.84 95% Confidence Interval ( 0.80 to 0.88 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 2 for Diagnostic Test Data for Disease Using Threshold C Groups [1] Participants Without Disease Specificity [2] 0.94 95% Confidence Interval ( 0.89 to 0.99 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 3 for Diagnostic Test Data for Disease Using Threshold C Groups [1]", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "All groups", "definition": "Area Under the Curve [2] 0.91 95% Confidence Interval ( 0.89 to 0.95 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: The Area Under the Curve was estimated based on the sensitivity and specificity measures for each of three thresholds (A, B, and C) [2] Other relevant estimation information: No text entered. 27 DRAFT \u2013 Diagnostic Test Accuracy Example \u2013 Public Display 9-28-09 Reported Adverse Events", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "nausea", "definition": "# participants affected/at risk # events 128/2500 (5.12%) 130", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Measured Values", "definition": "Reference Drug 150 mgTest Drug 150 mg Number of Participants [units: Participants] 14 14 Plasma Decay Half-Life (t1/2) [units: hours] Least Squares Mean \u00b1 Standard Deviation 29.99 \u00b1 4.84 29.99 \u00b1 4.34 U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANOVA", "definition": "P-Value [3] 0.784755 Other Estimated Parameter [Ratio of AUC (0 - \u221e) values] [4] 100.73 90% Confidence Interval (97.96 to 103.36) [1] Additional details about the analysis, such as null hypothesis and power calculation:", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "No text entered", "definition": "[2] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: No text entered. [3] Other relevant information, such as adjustments or degrees of freedom: No text entered. [4] Other relevant estimation information: Ratio of AUC (0 - \u221e) values = Test Drug 150mg/Reference Drug 150mg 34 DRAFT \u2013 Bioequivalence Study Example \u2013 Public Display 9-28-09 35 5. Primary Outcome Measure: Plasma Decay Half-Life (t1/2)", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Test Drug", "definition": "150 mg Number of Participants [units: Participants] 14 14 Time to Reach Maximum Observed Plasma Concentration (Tmax) [units: hours] Mean \u00b1 Standard Deviation 2.96 \u00b1 1.00 2.79 \u00b1 1.26 3. Primary Outcome Measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "mg", "definition": "Number of Participants [units: Participants] 14 14 Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - \u221e)] [units: mcg*h/mL] Mean \u00b1 Standard Deviation 153.33 \u00b1 35.96 154.45 \u00b1 36.81 Statistical Analysis 1 for Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - \u221e)] Groups [1] Reference Drug 150 mg, Test", "sources": [ "FDAAA_Helpful_Hints_ResultsExamples.pdf" ], "source": "FDAAA_Helpful_Hints_ResultsExamples.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "access control", "definition": "Policy and procedure that defines accessibility to a physical space or electronic source of information. The policy usually includes the concept of audit trails, either paper (e.g., signature log) or electronic. adverse drug reaction (ADR) In the pre-approval clinical experience with a new medicinal product or with its new usage (particularly as the therapeutic dose[s] may not be established), all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase \u201cresponses to a medicinal product\u201d means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility (i.e., the relationship cannot be ruled out). Regarding marketed medicinal products, and ADR is a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting2). See also MRCT Center Clinical Research Glossary definition. adverse event (AE) In a subject or clinical-investigation subject administered a pharmaceutical product, any untoward medical occurrence which does not necessarily have a causal relationship with the treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). See also MRCT Center Clinical Research Glossary definition. amendment (to the protocol) See protocol amendment.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "analysis dataset", "definition": "The final data set, including derived items and excluding redundant data points, which is used to perform the analyses required for safety assessment, efficacy assessment, submission to regulatory authorities, or other review. Can be comprised of one or more data files.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "analysis file", "definition": "Same as analysis dataset in the context of the GCDMP.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "annotated crf", "definition": "A document that maps the names of the collected items to their corresponding database tables, variable item names, forms, visits and any other objects needed for a person to correctly analyze data collected in a clinical trial. Annotated collection documents are required so that any person can understand where variables for analysis originate. applicable regulatory requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. Application Service provider (ASP) An application service provider is a vendor who provides, manages and distributes software- based services to customers over a network. approval (in relation to institutional review boards) The affirmative decision of the institutional review board (IRB) that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "audit", "definition": "A systematic and independent examination of trial-related activities and documents to determine whether the trial-related activities being evaluated were conducted and the data were recorded, analyzed and accurately reported according to the protocol, the sponsor\u2019s standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s).", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "audit certificate", "definition": "A declaration of confirmation by the auditor that an audit has taken place.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "audit report", "definition": "A written evaluation by the sponsor\u2019s auditor of the results of the audit.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "audit trail", "definition": "Documentation that allows reconstruction of the course of events.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "batch job", "definition": "A series of processes run in an electronic system that perform specific tasks, such as data validation, query generation, external data upload, or lab reference range normalization.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "biologics", "definition": "A biological product (as a vaccine or blood serum) used in medicine. blinding/masking A procedure in which one or more parties to the trial is kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double- blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "case report form (CRF)", "definition": "A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDISC", "definition": "Acronym for the Clinical Data Interchange Standards Consortium.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "central lab", "definition": "A vendor contracted for a clinical trial that processes samples collected from subjects and provides the results of laboratory tests or other medical analyses (e.g., ECG results, pathology results) to the sponsor. Refer to the Laboratory Data Handling chapter.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "change control", "definition": "A procedure that defines how planned changes to any part of a computer system are handled in a manner as to maintain compliance with required functionality of that system. The procedure ensures that changes applied to the system do not unexpectedly impact the functionality of the system in question, or any other computer systems. The procedure should also define how unexpected changes to a system are prevented and managed.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "checklist", "definition": "(ASQ) A tool used to ensure that all important steps or actions in an operation have been taken. Checklists contain items that are important or relevant to an issue or situation. Checklists are often confused with check sheets and data sheets.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CLIA", "definition": "See Clinical Laboratory Improvement Amendments. Clinical Laboratory Improvement Amendments (CLIA) Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. See www.fda.gov/medicaldevices/deviceregulationandguidance/ for more information. clinical trial/study Any investigation using human subjects that is intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) for the purpose of ascertaining its safety and/or efficacy. The terms \u201cclinical trial\u201d and \u201cclinical study\u201d are synonymous. See also MRCT Center Clinical Research Glossary definition. clinical trial/study report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports). See also MRCT Center Clinical Research Glossary definition", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "code libraries", "definition": "A repository of validated programming logic that can be used during the programming of edit checks or other programs used in the collection, review, or analysis of clinical trial data.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "common causes", "definition": "(ASQ) Causes of variation that are inherent in a process over time. They affect every outcome of the process and everyone working in the process. See also special causes. comparator (product) An investigational or marketed product (i.e., active control) or placebo used as a reference in a clinical trial. compliance (in relation to trials) Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "composite endpoint", "definition": "Overall outcome that the protocol is designed to evaluate based on more than one common endpoint such as myocardial infarction plus repeat intervention.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "compound", "definition": "A chemical molecule with potential pharmacological activity.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "confidentiality", "definition": "Prevention of disclosure of a sponsor\u2019s proprietary information or of a subject\u2019s identity to unauthorized individuals. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "conformance", "definition": "(ASQ) An affirmative indication or judgment that a product or service has met the requirements of a relevant specification, contract, or regulation.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "contract", "definition": "A written, dated, and signed agreement that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters between two or more involved parties. The protocol may serve as the basis of a contract. coordinating committee A committee that a sponsor may organize to coordinate the conduct of a multi-center trial. coordinating investigator An investigator assigned responsibility for the coordination of investigators at different centers that are participating in a multi-center trial. contract research organization (CRO) A person or an organization (e.g., commercial, academic, or otherwise) contracted by the sponsor to perform one or more of a sponsor\u2019s trial-related duties and functions. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "control chart", "definition": "(ASQ) A chart with upper and lower control limits on which values of some statistical measure for a series of samples or subgroups are plotted. The chart frequently shows a central line to help detect a trend of plotted values toward either control limit. corrective action (CA) (ASQ) The implementation of solutions that lead to the reduction or elimination of an identified problem.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CS", "definition": "Clinically Significant. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "data cleaning", "definition": "The process of collecting, reviewing, and confirming modifications to clinical data in such a way that data provided for statistical analysis is complete, accurate, and consistent with other data points.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "data module", "definition": "A category of a type of data, such as CRF.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "database backup", "definition": "A duplicate copy of all electronic data and metadata that can be retrieved in the event of system failure or data corruption.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "database lock", "definition": "The closing of a database after all clinical trial data has been reviewed, queries resolved and issues addressed, such that the database cannot be altered in any way. development/test environment Computer system instances that are used for study build and test, prior to release to the production instance. Defined quality procedures and documentation allow transition of programming code from one instance to another.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "device", "definition": "I. A means of data collection such as a paper CRF, Personal Digital Assistant, or medical instrumentation. II. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "direct access", "definition": "Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor\u2019s monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects\u2019 identities and sponsor\u2019s proprietary information. disaster recovery plan A disaster recovery plan is a comprehensive statement of consistent actions to be taken before, during and after a disaster. The plan should be documented and tested to ensure the continuity of operations and availability of critical resources in the event of a disaster. (www.drj.com)", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "discrepancy", "definition": "Inconsistency in two or more data points collected in a clinical trial that must be addressed prior to database lock.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "documentation", "definition": "All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, or results of a trial; the factors affecting a trial; and the actions taken.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "double data entry", "definition": "The process of purposely entering clinical trial data twice for studies with paper collection media. The two entries are done independently. The goal is to ensure entry into the electronic system is completed without transcription errors.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "e-CRF", "definition": "Acronym for electronic case report form. An auditable electronic record designed to record information to be reported to the sponsor on each trial subject, as required by the clinical trial protocol. See also case report form. edits - hard and soft edit Programmed or manual verifications performed on a clinical database for the purpose of ensuring a quality final analysis set for analysis. Hard edits refer to verifications that require a data change or entry in order to resolve it while Soft edits also accept a confirmation of the existing data.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "electronic record", "definition": "Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "electronic signature", "definition": "Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "electronic submission", "definition": "The set of required documents for a submission, rendered in an acceptable electronic format that is transmitted to a regulatory agency in lieu of paper documents for review and approval.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "endpoint", "definition": "Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "essential documents", "definition": "Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see ICH E6, Section 8. \u201cEssential Documents for the Conduct of a Clinical Trial\u201d).", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "exposure", "definition": "The condition of being subject to some effect or influence; in context of a clinical trial this generally refers to exposure to the test article/drug.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "external data", "definition": "Data that are collected externally and merged in the CDMS or analyzed together with data collected on the e/CRF.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "false negative", "definition": "A test result that is erroneously classified in a negative category (as of diagnosis) because of imperfect testing methods or procedures. In statistics a Type II error.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "false positive", "definition": "A test result that shows evidence of a result or condition although it is not actually present. In statistics, a Type I error.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "field", "definition": "A particular area (as of a record in a database) in which the same type of information is regularly recorded.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "flag", "definition": "A tag placed on a data point that defines a status (e.g., discrepant, closed, or other status) that indicates an action is required. flow diagram, flow chart A graphic means for depicting the steps or activities that constitute a process. The flow diagram (flow chart) is constructed from standard symbols (the delay and database symbols have been added to Juran\u2019s list4). The activity symbol is a rectangle that designates an activity. Within the rectangle is a brief description of that activity. The decision symbol is a diamond that designates a decision point from which the process branches into two or more paths. The path taken depends on the answer to the question that appears within the diamond. Each path is labeled to correspond to an answer to the question. The terminal symbol is a rounded rectangle that unambiguously identifies the beginning or end of a process. \u201cStart\u201d or \u201cbegin\u201d is used to designate the starting point of a process flow. \u201cStop\u201d or \u201cend\u201d is used to designate the end of process flow. The document symbol is a document pertinent to the process. The flow line represents a process path that connects process elements. The arrowhead indicates the direction of the flow. The connector is a circle that is used to indicate a continuation of the flow diagram. The delay symbol is a rectangle rounded on one side that identifies a waiting point or delay in the process flow. The database symbol is a cylinder that represents a database application and the contained data.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "frozen", "definition": "A temporary locked state for data that allows the generation of queries but does not allow a change to data points.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "global library", "definition": "In a Clinical Data Management System, the superset of all standard objects (e.g., CRF modules, edit checks, fields, etc.). Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "hard coding", "definition": "Computer programs utilize logic and hardware to allow dynamic responses based on user input. For example, Web site can be programmed to tabulate the total bill when books are selected for purchase on-line or the average weight of the patients in the active treatment arm each time a program is run on a dataset. \u201cHard coding\u201d is the limiting of the dynamic response by actually typing the data in the computer program itself rather than letting the data come from a dataset or the user. This approach can be dangerous because it is not visible in the analysis tables and listings or to the regulatory authorities and because it is easily forgotten once typed into the computer program.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "hard lock", "definition": "The final state of the database where no changes are permitted and all user access is removed.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "impartial witness", "definition": "A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject\u2019s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "in-control process", "definition": "(ASQ) A process in which the statistical measure being evaluated is in a state of statistical control (i.e., the variations among the observed sampling results can be attributed to a constant system of chance causes). See also out-of-control process. independent data-monitoring committee (IDMC) (data and safety monitoring board, monitoring committee, data monitoring committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints. Such a committee may also recommend to the sponsor whether to continue, modify, or stop a trial. independent ethics committee (IEC) An independent body\u2014i.e., a review board or a committee, whether institutional, regional, national, or supranational, constituted of medical professionals and non-medical members\u2014that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection. These responsibilities are accomplished by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to IECs may differ among countries but should allow the IEC to act in agreement with GCP, as described in this guideline.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "informed consent", "definition": "A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial after having been informed of all aspects of the trial that are relevant to the subject\u2019s decision to participate. Informed consent is documented by means of a written, signed, and dated informed-consent form. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "inspection", "definition": "I. (ICH) The act by a regulatory authority (or authorities) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor\u2019s and/or contract research organization\u2019s (CRO\u2019s) facilities, or at other establishments deemed appropriate by the regulatory authority. II. (ASQ) Measuring, examining, testing, and gauging one or more characteristics of a product or service and comparing the results with specified requirements to determine whether conformity is achieved for each characteristic. institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted. institutional review board (IRB) An independent body\u2014constituted of medical, scientific, and non-scientific members\u2014that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "instrument", "definition": "A device for capturing or measuring the present value of a quantity under observation. interim clinical trial/study report A report of intermediate results and their evaluation based on analyses performed during the course of a trial.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "intervention", "definition": "A method of interfering with the outcome or course, especially of a condition or process. See also MRCT Center Clinical Research Glossary definition. Investigational New Drug application (IND) An IND application is submitted to the FDA when a sponsor or investigator wishes to initiate trials with human subjects. The IND regulations can be found at the following link: https:// www.fda.gov/cber/ind/ind.htm . \u201cND\u201d is synonymous with \u201cNotice of Claimed Investigational Exemption for a New Drug.\u201d See also MRCT Center Clinical Research Glossary definition. investigational product A pharmaceutical form of an active ingredient or placebo that is being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, for an unapproved indication, or to gain further information about an approved use. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "investigator", "definition": "A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also subinvestigator. See also MRCT Center Clinical Research Glossary definition. investigator/institution An expression meaning \u201cthe investigator and/or institution, where required by the applicable regulatory requirements.\u201d", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "investigator meeting", "definition": "The kickoff meeting for an upcoming trial where the participating investigators review and provide feedback on the protocol or procedures in a protocol. Training of the principal investigator or other site staff on protocol procedures and/or EDC system entry is conducted at the investigator meeting as well. investigator\u2019s brochure A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects (see ICH E6, Section 7. \u201cInvestigator\u2019s Brochure\u201d).", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ISO", "definition": "(ASQ) English acronym for International Organization for Standardization. ISO 9000 series standards (ASQ) A set of five individual, but related, international standards on quality management and quality assurance developed to help companies effectively document the elements that should be implemented to maintain an efficient quality system. Initially published in 1987, the standards are not specific to any particular industry, product, or service. The standards were developed by the International Organization for Standardization (ISO), a specialized international agency for standardization that is composed of the national standards bodies of 91 countries.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "legacy system", "definition": "An electronic system previously in production, but no longer actively used, that may contain data needed for current analysis or other use and therefore must be maintained by the sponsor organization. legally acceptable representative An individual, juridical, or other type of body that is authorized under applicable law to consent, on behalf of a prospective subject, to the subject\u2019s participation in the clinical trial.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "local lab", "definition": "Local labs are labs in close proximity to individual clinical study sites or patients and are most often used when timely results are needed.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MedDRA", "definition": "Medical Dictionary for Regulatory Activities is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products. See www.meddra.org for additional information.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "medical monitor", "definition": "An individual, other than the principle investigator, who evaluates clinical trial data from a safety perspective.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "medical monitoring", "definition": "The act of evaluating the clinical trial data from a safety perspective.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "monitoring", "definition": "The act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "monitoring report", "definition": "A written report to the sponsor that is produced by the monitor after each site visit and/or other trial-related communication, as specified by the sponsor\u2019s SOPs.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "multi-center trial", "definition": "A clinical trial that is conducted according to a single protocol but at more than one site and therefore is carried out by more than one investigator. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NCS", "definition": "Non Clinically Significant. new drug application (NDA) The documentation submitted to the U.S. Food and Drug Administration. As described by the FDA: The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions: Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. Whether the drug\u2019s proposed labeling (package insert) is appropriate, and what it should contain. Whether the methods used in manufacturing the drug and the controls used to maintain the drug\u2019s quality are adequate to preserve the drug\u2019s identity, strength, quality, and purity. The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.5 The NDA regulations are 21 CFR 314.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "non-clinical study", "definition": "Biomedical studies that are not performed on human subjects.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "open access", "definition": "See National Cancer Institute\u2019s cancer Biomedical Informatics Grid (caBIG\u00ae) for additional details.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "open development", "definition": "See National Cancer Institute\u2019s cancer Biomedical Informatics Grid (caBIG\u00ae) for additional details.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "open source", "definition": "See National Cancer Institute\u2019s cancer Biomedical Informatics Grid (caBIG\u00ae) for additional details. opinion (in relation to an independent ethics committee) The judgment and/or the advice provided by an independent ethics committee (IEC). See also independent ethics committee. out-of-control process (ASQ) A process in which the statistical measure being evaluated is not in a state of statistical control (i.e., the variations among the observed sampling results can be attributed to a constant system of chance causes). See also in-control process. original medical record See source documents.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Pareto Principle / 80-20 rule", "definition": "An observation that 20% of the input creates 80% of the result.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "phase I - IV", "definition": "Refer to the FDA glossary (clinicaltrials.gov). See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "predicate rule", "definition": "The overreaching regulations that the industry must follow for GxP (Good \u201cAnything\u201d Practice or any collection of quality guidelines). production environment The location (e.g., website, server, EDC) where real clinical data is entered and stored.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "protocol", "definition": "A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these details could be provided in other protocol-referenced documents. Throughout the ICH GCP Guideline, the term \u201cprotocol\u201d refers to protocol and protocol amendments. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "protocol amendment", "definition": "A written description of a change (or changes) to, or formal clarification of, a protocol.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "protocol deviation", "definition": "Any alteration/modification to the IRB-approved protocol. The protocol includes the detailed protocol, protocol summary, consent form, recruitment materials, questionnaires, and any other information relating to the research study. (Partners Human Research Committee; http://healthcare.partners.org)", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "protocol violation", "definition": "Any protocol deviation that is not approved by the IRB prior to its initiation or implementation. (Partners Human Research Committee; http://healthcare.partners.org )", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "quality assurance (QA)", "definition": "All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and with the applicable regulatory requirement(s). quality control (QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. quality assurance/quality control (ASQ) Two terms with many interpretations because of the multiple definitions for the words \u201cassurance\u201d and \u201ccontrol.\u201d For example, \u201cassurance\u201d can mean the act of giving confidence, the state of being certain, or the act of making certain. \u201cControl\u201d can mean an evaluation to indicate needed corrective responses, the act of guiding, or the state of a process in which the variability is attributable to a constant system of chance causes (for a detailed discussion on the multiple definitions, see ANSI/ISO/aSQC a35342, Statistics\u2014Vocabulary and Symbols\u2014Statistical Quality Control). One definition of quality assurance includes the following: all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. One definition for quality control includes the following: the operational techniques and activities used to fulfill requirements for quality. Often, however, \u201cquality assurance\u201d and \u201cquality control\u201d are used interchangeably to discuss the actions that ensure the quality of a product, service, or process.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "quality audit", "definition": "(ASQ) A systematic, independent examination and review to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "random sampling", "definition": "(ASQ) A commonly used sampling technique in which sample units are selected in such a manner that all combinations of n units under consideration have an equal chance of being selected as the sample.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "randomization", "definition": "The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments. Used to reduce bias. See also MRCT Center Clinical Research Glossary definition. regulatory authorities Bodies having the power to regulate. In the ICH GCP Guideline, the expression \u201cregulatory authorities\u201d includes the authorities that review submitted clinical data and the authorities that conduct inspections (see Section 1.291). These bodies are sometimes referred to as \u201ccompetent authorities.\u201d", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "research misconduct", "definition": "Falsification of data in proposing, designing, performing, recording, supervising, or reviewing research or in reporting research results. Falsification includes acts of omission and commission. Deliberate noncompliance with the regulations can be considered misconduct but is secondary to falsification of data. Research misconduct does not include honest error or differences of opinion.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "safety database", "definition": "A database typically used by Drug Safety or Pharmacovigilence departments to collect adverse event data.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAS transport file", "definition": "A machine-independent file that allows you to move a SAS data set from one operation system to another. ( http://kb.iu.edu/data/aevb.html) serious adverse event (SAE); serious adverse drug reaction (serious ADR) Any untoward medical occurrence that at any dose: \uf0b7 Results in death; \uf0b7 Is life-threatening; \uf0b7 Requires hospitalization or prolongs hospitalization of a subject; \uf0b7 Results in persistent or significant disability/incapacity; or \uf0b7 Is a congenital anomaly/birth defect. Service Level Agreement (SLA) - from the Vendor chapter An SLA is part of a service contract where the level of service is formally defined.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "source data", "definition": "All information that is necessary for the reconstruction and evaluation of the trial, including information about clinical findings, observations, or other activities in a clinical trial. Source data are contained in source documents such as original records or certified copies of original records.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "source documents", "definition": "Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects\u2019 diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "special causes", "definition": "(ASQ) Causes of variation that arise because of special circumstances. These causes are not an inherent part of a process. Special causes are also referred to as assignable causes. See also common causes.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "specification", "definition": "(ASQ) A document that states the requirements to which a given product or service must conform.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "sponsor", "definition": "An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. See also MRCT Center Clinical Research Glossary definition.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "sponsor-investigator", "definition": "An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). A sponsor-investigator must fulfill the obligations of both a sponsor and an investigator. standard operating procedures (SOPs) Detailed instructions written to achieve uniformity of the performance of a specific function. statistical process control (SPC) (ASQ) The application of statistical techniques to control a process. Often the term \u201cstatistical quality control\u201d is used interchangeably with \u201cstatistical process control.\u201d statistical quality control (SQC) (ASQ) The application of statistical techniques to control quality. Often the term \u201cstatistical process control\u201d is used interchangeably with \u201cstatistical quality control,\u201d although statistical quality control includes acceptance sampling as well as statistical process control.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "sub-investigator", "definition": "Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also investigator. subject/trial subject An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. See also MRCT Center Clinical Research Glossary definition. subject identification code A unique identifier assigned by the investigator to each trial subject to protect the subject\u2019s identity and to be used in lieu of the subject\u2019s name when the investigator reports adverse events and/or other trial related data.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "trial site", "definition": "The location(s) where trial-related activities are actually conducted.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "trigger", "definition": "An event that precipitates other events.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Type I error", "definition": "(ASQ) An incorrect decision to reject something that is acceptable, such as a statistical hypothesis or a lot of products.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Type II error", "definition": "(ASQ) An incorrect decision to accept something that is unacceptable.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "UAT", "definition": "User Acceptance Testing. unexpected adverse drug reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator\u2019s brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). See the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "vulnerable subjects", "definition": "Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include subjects with incurable diseases, persons in nursing homes, unemployed or impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "well-being (of the trial subjects)", "definition": "The physical and mental integrity of the subjects participating in a clinical trial.", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WHOdrug", "definition": "WHO Drug is a dictionary of medicinal product information. It is used to identify drug names and provides information about a drug's active ingredients and its therapeutic use(s).", "sources": [ "GCDMP_Glossary.pdf" ], "source": "GCDMP_Glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INSPECTION", "definition": "CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. OF INDIA", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "November-2010", "definition": "CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SLA", "definition": "State Licencing Authority CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 4 of 17", "definition": "CLINICAL TRIAL INSPECTION PROGRAMME 2 Objectives : The aims of the programme are: a. To verify GCP compliance to protect the rights, safety and well being of the subjects involved in clinical trial b. To verify the credibility and integrity of clinical trial data generated c. To verify the compliance with various regulatory provisions as per Drugs & Cosmetics Rules The purpose of this programme is to provide direction to inspectors/CDSCO officers for conducting inspection of site of clinical trial, sponsor / CRO\u2019s facilities involved in clinical trial and information to investigators, sponsor/ CRO\u2019S about procedures for inspection and follow up of action. 3 Scope and extent of the programme: Clinical trial inspection programme covers all clinical trial sites and sponsor / CRO\u2019s facilities involved in clinical trial of drugs including biological and medical device covered under Drugs & Cosmetics Act. CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 5 of 17", "definition": "4. Planning for Inspection: Inspection can be conducted before, during or after a clinical trial is completed. 4.1 Selection of studies: Inspection can be carried out as a routine surveillance or for any specific cause(s).Study may be selected for inspection based on, but not restricted to the following criteria: 4.1.1", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Nature of study", "definition": "4.1.2 For regulatory decision based on clinical trial data 4.1.3", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Complaints", "definition": "4.1.5 Vulnerability of subjects 4.1.6 Number of CT including number of subject enrolled at a", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "particular site", "definition": "4.2 Inspection assignments: CDSCO HQ will issue instruction to the CDSCO Officers /Inspectors to conduct the inspection identifying the Clinical trial, name, address, contact number of clinical trial site, sponsor / CRO\u2019s facilities to be inspected. It may also identify the type and purpose of the inspection and provide background materials like study protocol, CRF etc. 4.3 Preparing for inspection: The inspector shall go through the information provided by CDSCO HQ and develop a plan for conducting the inspection. CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 6 of 17", "definition": "4.4 Scheduling the inspection: Inspection of clinical trial site would generally be pre-announced to ensure availability of the Investigator / Sub- Investigator and other personnel along with study records at the time of the inspection. The date of inspection and other arrangements would be finalised by the CDSCO Officers / Inspector(s) in coordination with the investigator /sponsor/ CRO. Under some specific circumstances unannounced inspection of clinical trial sites can be carried out as per the direction of CDSCO HQ. Inspection of CRO/Sponsor can be conducted without prior notice. 5. Conducting the inspection: 5.1 Clinical Trial Sites: The inspection includes verification of essential documents to determine whether the trial related activities were in accordance with the protocol, GCP guidelines published by DGHS, Govt. of India and Schedule Y as well as other applicable regulatory requirements. When inspection is carried out after completion of the clinical trial, it will include comparison of data generated by the sponsor with source documents at the clinical trial sites and Case Record Form (CRF) in the investigator\u2019s files. If it is a routine surveillance or \u201cfor cause\u201d inspection of an ongoing clinical trial, the comparison will generally include source documents and CRF. 5.1.1 Opening interview: Inspector should meet investigator / key person of Sponsor and present his / her identity card. The inspector should provide verbal summary of methods and procedures to be followed during the inspection. CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 7 of 17", "definition": "During opening interview following main activities should be found out: 5.1.1.1 Investigator prior education and GCP experience, GCP training provided by the sponsor. 5.1.1.2 Who did what, when, where and how with respect to following: \uf0b7 Obtaining Informed consent of subjects, \uf0b7 Screening and admission of subjects to the study, \uf0b7 Receipt, handling, administration, return of investigational product, \uf0b7 Collection and analysing of data, \uf0b7 Recording, transcribing and reporting of data to sponsor, \uf0b7 Archiving the data 5.1.1.3 How did the investigator identify the subjects for the study, 5.1.1.4 Date of enrolment first and last subject 5.1.1.5 About Ethics Committee the site is using 5.1.1.6 Whether the investigator has copies of protocol, permission from CDSCO, undertaking by the investigator etc. 5.1.1.7 Information about unexpected and serious adverse events (if any) occurred at the site, 5.1.1.8 Information about monitoring/auditing of the site by sponsor/CRO. During the interview other relevant facts may also be found out. 5.1.2 ORGANIZATION & DELEGATION OF RESPONSIBILITIES: Inspector shall verify / obtain following: 5.1.2.1 Brief about study site. 5.1.2.2 Status of the study. 5.1.2.3 Whether investigator has agreement with sponsor for the study. 5.1.2.4 Whether financial & Confidentiality agreement with Investigator and concerned laboratory (ies) in place. 5.1.2.5 In Investigator undertaking protocol title, Investigator\u2019s name, address, telephone no of site, qualification, Name & address of laboratories, Name of Sub-Investigator etc are in-compliance with Schedule Y of Drugs & Cosmetics Rules 1945. CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 8 of 17", "definition": "5.1.2.6 Obtain list of all clinical trials performed by investigator. The list should have information such as \uf0b7 Protocol Number \uf0b7 Protocol Title \uf0b7 Name of Sponsor/CRO \uf0b7 Study date 5.1.2.7 Determine whether authority for conducting various Clinical trial related activities were delegated properly by the Investigator to the competent personnel so that investigator was able to supervise the study adequately. Obtain a list of personnel with delegated activity. 5.1.2.8 Documents following; \uf0b7 Date of EC / IEC approval including initial review of protocol, amendment, ICD etc. \uf0b7 Date of screening of first subject, \uf0b7 Date of signing ICF by the first subject \uf0b7 Date of first administration of IP, \uf0b7 Date of last follow up of any subject, 5.1.2.9 List the name and address of facilities involved in laboratory test required by protocol. Verify accreditation status and adequacy of these facilities to perform the specified test, 5.1.2.10 Obtain a copy of site enrolment log, 5.1.2.11 Determine whether SOP\u2019s for various activity are established and documented, 5.1.3 Study Protocol 5.1.3.1 Determine if, there are any difference between protocol provided to CDSCO and the protocol in the Investigator\u2019s file with respect to following \uf0a7 Version number and effective date \uf0a7 Eligibility of Subject (Inclusion/ Exclusion Criteria) \uf0a7", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dosage", "definition": "\uf0a7 Route of administration \uf0a7", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Frequency of dosage", "definition": "\uf0a7 Randomisation & Blinding process CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 9 of 17", "definition": "\uf0a7 Verify whether Investigator follow the protocol as", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "approved", "definition": "\uf0a7 Version number and EC approval of amendments 5.1.4 Subject record & Informed consent: 5.1.4.1 Review the Informed Consent Form (ICF) signed by the subjects. If the number of subjects at site is relatively small (e.g.20or less) 100% of the ICF can be reviewed. Determine the following: 5.1.4.2 whether ICF have all the elements enlisted in Appendix V of Schedule Y, 5.1.4.3 whether IC has been obtained from each subjects prior to participation of the subject in the study, 5.1.4.4 whether signature/thumb impression of the subjects have been affixed with date, 5.1.4.5 whether in case of illiterate subjects or illiterate representative of a subject, there are signature and details of an impartial witness, 5.1.4.6 Have witness/ signature been personally dated, 5.1.4.7 Have patient signature been personally dated? 5.1.4.8 Has the dated signature of the designated person for administering informed consent (IC) been affixed? 5.1.4.9 Is the designated person for administering IC medically qualified? 5.1.4.10 If IC has been administered by a designated person who is not medically qualified, is there evidence that subject's queries of a medical nature were answered by a medically qualified person or the investigator? 5.1.4.11 Is the completed ICF signed and dated by the investigator? 5.1.5 Source Documents and Case Record Form 5.1.5.1 Verify condition, completeness, legibility, accessibility of the investigators source data file. 5.1.5.2 Determine whether subjects who were enrolled and /or completed the study meet inclusion and exclusion criteria; 5.1.5.3 Determine whether subject received the test drug with respect to dose and frequency specified according to the protocol; CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 10 of 17", "definition": "5.1.5.4 Determine whether safety/ efficacy end point data was collected and reported in accordance with the protocol; 5.1.5.5 Does medical record mentions subject ID/ name /hospital registration number / and indication that subjects are participating in a clinical trial 5.1.5.6 Whether all adverse events were reported in CRF; 5.1.5.7 Compare the source document with CRF and determine whether source data have been correctly transcribed in CRF; 5.1.5.8 Verify whether all SAE\u2019s have been reported to the sponsor (within 24 hours) and EC (within 7 working days); 5.1.5.9 Verify whether adequate medical care have been given to the subject especially in the event of inter current illness, adverse events including abnormal lab parameters; 5.1.6 Ethics Committee (EC) / Independent Ethics Committee (IEC): 5.1.6.1 Identify the name , address of the EC/ IEC in the approval letter and compare it with that stated in investigators undertaking ; 5.1.6.2 Verify if IEC approval letter mention study code , Protocol title and version number of the protocol, list of other documents reviewed, list of members present at the meeting, quorum of five members as specified in Schedule Y satisfied, date, time , venue of the meeting, signature and date of member secretary / Chairman; 5.1.6.3 In case the site does not have an IEC, verify whether following are in place: \uf0b7 Statement of the investigator / institution that approval granted by another IEC would be abided by & statement from the approving IEC that they would take responsibility for ongoing supervision of the site; \uf0b7 Has the investigator submitted reports of all SAEs to the IEC and apprised the EC/IEC about the trial progress? CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 11 of 17", "definition": "5.1.7 Sponsor: Verify/ determine: 5.1.7.1 Whether a clinical trial Investigators agreement has been signed for this study with the sponsor; 5.1.7.2 Whether investigator maintains copies of all reports submitted to the sponsor; 5.1.7.3 Whether all SAE are reported to sponsor within 24 hours; 5.1.7.4 Whether all CRFs were submitted to sponsor after completion of study; 5.1.7.5 Whether all dropouts and reasons thereof were reported to sponsor; 5.1.7.6 The method and frequency of monitoring the progress of the study by the sponsor; 5.1.7.7 Whether a log of onsite monitoring visit is maintained at the site; 5.1.8 Test Drug Accountability: 5.1.8.1 Review individual subject record to verify the correct dose administration with respect to dose, frequency, route of administration; 5.1.8.2 Determine whether unqualified /unauthorised persons administered/dispensed the test drug 5.1.8.3 Determine whether adequate record of qty. of test drug received , dispensed/ destroyed/returned is maintained ; 5.1.8.4 Determine whether storage condition/monitoring method are as per protocol/recommendation; 5.1.8.5 Whether trial medication are maintained under controlled access; 5.1.8.6 Have un-used trial medications been returned to the sponsor or disposed of according to protocol? In case of destruction at site, is there a certificate of destruction on file? 5.1.8.7 Are the drugs dispensing records being maintained properly? 5.1.8.8 Are the records for reconciliation of all IPs received from the sponsor maintained? CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 12 of 17", "definition": "5.1.9 Record retention: 5.1.9.1 Is adequate space available at the site for retention of", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "documents", "definition": "5.1.9.2 Determine whether documents are maintained properly and for the period as specified and necessary measures", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "premature", "definition": "destruction; 5.1.9.3 Determine who maintained custody of the documents and means for assuring prompt action; 5.1.10 Concluding the Inspection: The inspector should conclude the inspection with final discussion with the Investigator. During discussion the inspector should explain inspection finding .The inspector may also issue a list of observation at the conclusion of inspection. 5.2 Inspection of CRO/Sponsor The inspection includes verification of essential documents to compare practice and procedure followed by the CRO/Sponsor to that committed in the clinical trial application and GCP guidelines published by DGHS, Govt. of India and Schedule-Y as well as other applicable regulatory requirements. Inspection of CRO/Sponsor can be conducted without prior notice. During inspection following aspects may be verified. 5.2.1 Documents submitted to CDSCO and regulatory approvals obtained. 5.2.1.1 Clinical Trial application and DCGI approval letter 5.2.1.2 Import license application(Form 12) and import licence obtained (Form 11)Copy of license in Form 29 from (State Licencing Authority) SLA (in case of manufacture of test drugs) 5.2.1.3 Export NOC for biological samples 5.2.1.4 List of investigators 5.2.1.5 Investigator Undertaking (as per Appendix VII of Schedule Y) 5.2.1.6 Investigator's brochure 5.2.1.7 Protocol and Protocol amendments CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 13 of 17", "definition": "5.2.1.8 Patient Information Sheet and Informed Consent Form 5.2.1.9", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Case Record Form", "definition": "5.2.1.10 Ethics Committee approval and notifications to CDSCO 5.2.1.11 Unexpected and Serious Adverse Event Reports 5.2.1.12", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study report", "definition": "5.2.2 Organisation and personnel: 5.2.2.1 Company profile and overall structure, 5.2.2.2 Organization chart for management of the clinical trial, Structure and responsibilities for all activities involving investigational products. Departments, functions, and key", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocol", "definition": "development, Investigator's brochure, Case Record Form, Informed consent form (ICF), translations and amendments ,Selection of investigators, Regulatory approval, Ethics Committee (EC) approval, Monitoring, Quality assurance Adverse Event (AE) Reporting, Data Management , Statistical Analysis, Electronic Records/Clinical Database, Clinical Supplies-Investigational Products (IP) Archival. 5.2.2.3 Identify and determine the personnel responsible for", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "following", "definition": "\uf0b7 Authority to review and approve study documents \uf0b7 For final evaluations and decisions in the review of", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "study", "definition": "\uf0b7 For obtaining & reviewing adverse events and", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "qualifications", "definition": "\uf0b7 Job description of key stake holders \uf0b7 Verify clinical personnel training record \uf0b7 To obtain a list of external service providers and contractors and documentation of the service they provide. \uf0b7 Verify", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "various", "definition": "responsibilities and clinical trial related activities. CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 14 of 17", "definition": "5.2.3 Selection and monitoring of investigators 5.2.3.1 Obtain list of all investigators along with Investigator Undertaking, Signed Investigator Agreements 5.2.3.2 Criteria for selection of sites 5.2.3.3 Information provided to sites viz. Informed consent form, Protocol, Reports/publications of previous trials, Investigator's Brochure, Product labelling, Training, All versions and updates etc. 5.2.3.4 Investigator\u2019s non-compliance (If any) \uf0b7 Deviations from CDSCO regulations \uf0b7 Deviations form protocol \uf0b7 How sponsor handles serious deviations from approved protocol or Schedule Y /Indian GCP Guidelines. 5.2.3.5 Steps for correction: \uf0b7 Verify whether any investigators terminated? Review monitoring reports reported to CDSCO, \uf0b7 Any Non-compliant investigator /terminated? Reasons? 5.2.3.6 Selection of monitor: \uf0b7 List all monitors for study duration \uf0b7 Selection criteria for monitors \uf0b7 Job descriptions/responsibilities \uf0b7 Qualifications \uf0b7 Training Records and CVs \uf0b7 Reporting structure \uf0b7 Monitoring SOP Frequency, scope and process, Obtain a copy of SOP and check compliance, If no SOPs, interview monitors to check how monitoring was done , Monitoring Plan, Monitoring Reports 5.2.3.7 Review the Pre trial and periodic trial visit report in respect of following content: \uf0b7 Process of verifying compliance to protocol \uf0b7 Process of verifying investigator responsibilities \uf0b7 Ethics Committee Approvals Amendments/Re- approval Communication-progress reports/SAEs etc Validity/Completeness \uf0b7 Informed Consents, Confirmation of consent and process of consent. \uf0b7 Use of IEC approved forms. \uf0b7 Adequacy of consent documentation,", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "completeness", "definition": "CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 15 of 17", "definition": "\uf0b7 Which CRFs were compared to source docs? When and who verified CRFs against source data (hospital records, office charts, laboratory reports, etc.) at the study site. Form for data verification \uf0b7 Check copy of any SOPs and guidelines for data", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "verification", "definition": "\uf0b7 Data correction handling, Compliance to Monitoring Plan, Frequency, Follow up etc. 5.2.4 Quality Assurance (QA): 5.2.4.1 Verify SOP for QA audits and operation of quality", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "assurance unit", "definition": "5.2.4.2 Describe how the audit and monitoring are separated 5.2.4.3 Obtain list of audited trial 5.2.5 Adverse events reporting: 5.2.5.1 Verify sponsor\u2019s method for following up of adverse events and for dissemination of AE information to others Investigators: 5.2.5.2 Obtain list of SAE reported, Including death 5.2.5.3 Verify the timeline for reporting the SAE to CDSCO and other Investigators /EC; 5.2.6 Data collection and handling 5.2.6.1 Study tabulations: List of all studies for marketing", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Authorization", "definition": "application(compare to CRFs submitted) 5.2.6.3 If any subjects not included in the marketing Authorization application? Why not included? 5.2.6.4 Review of SOPS to verify compliance to assure the integrity of safety and efficacy data collected from clinical", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "investigators", "definition": "5.2.6.5 Verify that the SOPs were followed and document any", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "deviations", "definition": "5.2.6.6 Deviations/Data queries resolutions 5.2.6.7", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Statistical processes", "definition": "5.2.6.8 Primary endpoints Compare the tabulations with CRFs", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Record retention", "definition": "CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 16 of 17", "definition": "5.2.7 Electronic Record and Clinical database: 5.2.7.1 Person responsible for designing and developing data", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "base", "definition": "5.2.7.2 Can it be modified, or has it been modified? If so, by whom? 5.2.7.3 If the clinical investigator can modify it, how would the sponsor be aware of any changes? 5.2.7.4 Validation :Person responsible, Process, Documentation", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of process", "definition": "5.2.7.5 Error logs maintained for errors in software and systems? 5.2.7.6 Do error logs identify corrections made? 5.2.8 Data collection: Following aspects may be verified: 5.2.8.1 Responsibilities : Authorization to access the system, to enter data and to change data 5.2.8.2 Use of electronic data capture or data transcription from paper CRFs into an electronic record 5.2.8.3 Audit trail : to record Changes to electronic records, Person Responsible for the change and Time of the", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "change", "definition": "5.2.8.4 Process of data transmission from the clinical investigator", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "to sponsor or CRO", "definition": "5.2.9 Computerized System Security: Following aspects may be verified: 5.2.9.1 Management of system access e.g. access privileges, authorization/de-authorization procedures,", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "access controls", "definition": "5.2.9.2 Records of authorized personnel , Names, Titles. Description of their access privileges 5.2.9.3", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "identification", "definition": "code/password combinations, tokens, biometric signature, electronic signatures, digital signatures 5.2.9.4 Data security in case of disasters, e.g., power failure 5.2.9.5 Contingency plans and backup files 5.2.9.6 Controls in place to prevent data from being altered, browsed, queried, or reported via external software applications that do not enter through the protective", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "system software", "definition": "CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 17 of 17", "definition": "5.2.10 Investigational Product(IP): Following aspects may be verified: 5.2.10.1 Transferred data from central lab to sponsor 5.2.10.2 Integrity Procedures to ensure integrity of IP from manufacturing to receipt by the clinical investigator. 5.2.10.3 If IP met required release specifications by review of the Certificate of Analysis? 5.2.10.4 Storage of IP and the conditions of storage 5.2.10.5 Process of verification of IP integrity during shipment to investigator. 5.2.10.6", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "IP label", "definition": "5.2.10.7 If the test article was recalled, withdrawn, or returned? 5.2.10.8 Accountability: Following aspects may be verified: \uf0b7 Names and addresses of clinical investigators receiving IP Shipment, date (s), quantity, batch number. \uf0b7 Final disposition of the test article. \uf0b7 Detailed audit if serious violations are suspected. \uf0b7 Sufficient records to reconcile IP usage (compare the amount shipped to the investigators to the amount used and returned or disposed of). \uf0b7 Check whether all unused or reusable supplies of IP returned to the sponsor when either the investigator(S)", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "completed", "definition": "participation in the clinical investigation, or the investigation was terminated. If the test article was not returned to the sponsor, describe the method of disposition and determine if adequate records were maintained. 6. Reporting of inspection The Inspection should be documented in writing in both during and after inspection. After the inspection a narrative report containing details of inspection finding should be prepared and submitted to CDSCO (HQ). ****************", "sources": [ "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf" ], "source": "Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL", "definition": "REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY FOR DRUGS INTENDED FOR LONG-TERM TREATMENT OF NON-LIFE-THREATENING CONDITIONS", "sources": [ "ICH-E1.pdf" ], "source": "ICH-E1.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "dated 27 October 1994", "definition": "This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.", "sources": [ "ICH-E1.pdf" ], "source": "ICH-E1.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "E1", "definition": "THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL", "sources": [ "ICH-E1.pdf" ], "source": "ICH-E1.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Population Exposure", "definition": "b. Situations in which there is a need to quantitate the occurrence rate of an expected specific low-frequency ADE will require a greater long-term data base. Examples would include situations where a specific serious ADE has been identified in similar drugs or where a serious event that could represent an alert event is observed in early clinical trials. c. Larger safety data bases may be needed to make risk/benefit decisions in situations where the benefit from the drug is either (1) small (e.g., symptomatic improvement in less serious medical conditions) or (2) will be experienced by only a fraction of the treated patients (e.g., certain preventive therapies administered to healthy populations) or (3) is of uncertain magnitude (e.g., efficacy determination on a surrogate endpoint). d. In situations where there is concern that a drug may add to an already significant background rate of morbidity or mortality, clinical trials may need to be designed with a sufficient number of patients to provide adequate statistical power to detect prespecified increases over the baseline morbidity or mortality. e. In some cases, a smaller number of patients may be acceptable, for example, where the intended treatment population is small. 8. Filing for approval will usually be possible based on the data from patients treated through 6 months. Data on patients treated through 12 months must be submitted as soon as available and prior to approval in the United States and Japan but may be submitted after approval in the E.C.. In the U.S. the initial submission for those drugs designated as priority drugs must include the 12- months patient data. 3", "sources": [ "ICH-E1.pdf" ], "source": "ICH-E1.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL", "definition": "REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USE", "definition": "ICH HARMONISED TRIPARTITE GUIDELINE CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "dated 27 October 1994", "definition": "This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "E2A", "definition": "CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 27 October 1994, this guideline is recommended for adoption to the three regulatory parties to ICH I.", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTRODUCTION", "definition": "It is important to harmonise the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development. Thus, agreed definitions and terminology, as well as procedures, will ensure uniform Good Clinical Practice standards in this area. The initiatives already undertaken for marketed medicines through the CIOMS-1 and CIOMS-2 Working Groups on expedited (alert) reports and periodic safety update reporting, respectively, are important precedents and models. However, there are special circumstances involving medicinal products under development, especially in the early stages and before any marketing experience is available. Conversely, it must be recognised that a medicinal product will be under various stages of development and/or marketing in different countries, and safety data from marketing experience will ordinarily be of interest to regulators in countries where the medicinal product is still under investigational-only (Phase 1, 2, or 3) status. For this reason, it is both practical and well-advised to regard pre-marketing and", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "as", "definition": "interdependent, while recognising that responsibility for clinical safety within regulatory bodies and companies may reside with different departments, depending on the status of the product (investigational vs. marketed). There are two issues within the broad subject of clinical safety data management that are appropriate for harmonisation at this time: (1) the development of standard definitions and terminology for key aspects of clinical safety reporting, and (2) the appropriate mechanism for handling expedited (rapid) reporting, in the investigational (i.e., pre-approval) phase. The provisions of this guideline should be used in conjunction with other ICH Good Clinical Practice guidelines. II. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Post-study Events", "definition": "Although such information is not routinely sought or collected by the sponsor, serious adverse events that occurred after the patient had completed a clinical study (including any protocol-required post-treatment follow-up) will possibly be reported by an investigator to the sponsor. Such cases should be regarded for expedited reporting purposes as though they were study reports. Therefore, a causality assessment and determination of expectedness are needed for a decision on whether or not expedited reporting is required. 7 Clinical Safety Data Management F. INFORMING INVESTIGATORS AND ETHICS COMMITTEES/ INSTITUTIONAL REVIEW BOARDS OF NEW SAFETY INFORMATION International standards regarding such communication are discussed within the ICH GCP Guidelines, including the addendum on \"Guideline for the Investigator's Brochure.\" In general, the sponsor of a study should amend the Investigator's Brochure as needed, and in accord with any local regulatory requirements, so as to keep the description of safety information updated. 8 Clinical Safety Data Management", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Attachment 1", "definition": "KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS OF SERIOUS ADVERSE DRUG REACTIONS The following list of items has its foundation in several established precedents, including those of CIOMS-I, the WHO International Drug Monitoring Centre, and various regulatory authority forms and guidelines. Some items may not be relevant depending on the circumstances. The minimum information required for expedited reporting purposes is: an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Attempts should be made to obtain follow-up information on as many other listed items pertinent to the case. 1. Patient Details", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Initials", "definition": "Other relevant identifier (clinical investigation number, for example)", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Gender", "definition": "Age and/or date of birth", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Height", "definition": "2. Suspected Medicinal Product(s) Brand name as reported International Non-Proprietary Name (INN)", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Batch number", "definition": "Indication(s) for which suspect medicinal product was prescribed or tested Dosage form and strength Daily dose and regimen (specify units - e.g., mg, ml, mg/kg) Route of administration Starting date and time of day Stopping date and time, or duration of treatment 3. Other Treatment(s) For concomitant medicinal products (including non-prescription/OTC medicinal products) and non-medicinal product therapies, provide the same information as for the suspected product. 9 Clinical Safety Data Management 4. Details of Suspected Adverse Drug Reaction(s) Full description of reaction(s) including body site and severity, as well as the criterion (or criteria) for regarding the report as serious should be given. In addition to a description of the reported signs and symptoms, whenever possible, attempts should be made to establish a specific diagnosis for the reaction. Start date (and time) of onset of reaction Stop date (and time) or duration of reaction Dechallenge and rechallenge information Setting (e.g., hospital, out-patient clinic, home, nursing home) Outcome: information on recovery and any sequelae; what specific tests and/or treatment may have been required and their results; for a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction should be provided. Any autopsy or other post-mortem findings (including a coroner's report) should also be provided when available. Other information: anything relevant to facilitate assessment of the case, such as medical history including allergy, drug or alcohol abuse; family history; findings from special investigations. 5. Details on Reporter of Event (Suspected ADR)", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Telephone number", "definition": "Profession (speciality) 6. Administrative and Sponsor/Company Details Source of report: was it spontaneous, from a clinical investigation (provide details), from the literature (provide copy), other? Date event report was first received by sponsor/manufacturer Country in which event occurred Type of report filed to authorities: initial or follow-up (first, second, etc.) Name and address of sponsor/manufacturer/company Name, address, telephone number, and FAX number of contact person in reporting company or institution Identifying regulatory code or number for marketing authorisation dossier or clinical investigation process for the suspected product (for example IND or CTX number, NDA number) Sponsor/manufacturer's identification number for the case (this number must be the same for the initial and follow-up reports on the same case). 10", "sources": [ "ICH_E2A.pdf" ], "source": "ICH_E2A.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL", "definition": "REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USE", "definition": "ICH HARMONISED TRIPARTITE GUIDELINE STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "E3", "definition": "STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 30 November 1995, this guideline is recommended for adoption to the three regulatory parties to ICH", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTRODUCTION TO THE GUIDELINE.....................................................................1", "definition": "1. TITLE PAGE...........................................................................................................3 2. SYNOPSIS...............................................................................................................3 3. TABLE OF CONTENTS FOR THE INDIVIDUAL CLINICAL STUDY REPORT..................................................................................................................4 4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .......................4 5. ETHICS....................................................................................................................4 5.1 INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB)............................................................................................................4 5.2 ETHICAL CONDUCT OF THE STUDY.................................................................4 5.3 PATIENT INFORMATION AND CONSENT.........................................................4 6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE...........4 7. INTRODUCTION...................................................................................................5 8. STUDY OBJECTIVES...........................................................................................5 9. INVESTIGATIONAL PLAN .................................................................................5 9.1 OVERALL STUDY DESIGN AND PLAN - DESCRIPTION .................................5 9.2 DISCUSSION OF STUDY DESIGN, INCLUDING THE CHOICE OF CONTROL GROUPS................................................................................................6 9.3 SELECTION OF STUDY POPULATION...............................................................7 9.3.1 Inclusion Criteria........................................................................................7 9.3.2 Exclusion Criteria.......................................................................................7 9.3.3 Removal of Patients from Therapy or Assessment...................................7 9.4 TREATMENTS.........................................................................................................7 9.4.1 Treatments Administered ..........................................................................7 9.4.2 Identity of Investigational Product(s)........................................................7 9.4.3 Method of Assigning Patients to Treatment Groups ................................8", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "iv", "definition": "Structure and Content of Clinical Study Reports 16.1.10 Documentation of inter-laboratory standardisation methods and quality assurance procedures if used ...................................................................29 16.1.11 Publications based on the study ...............................................................29 16.1.12 Important publications referenced in the report .....................................29 16.2. PATIENT DATA LISTINGS..................................................................................29 16.2.1 Discontinued patients...............................................................................29 16.2.2 Protocol deviations....................................................................................29 16.2.3 Patients excluded from the efficacy analysis ..........................................29 16.2.4 Demographic data.....................................................................................29 16.2.5 Compliance and/or drug concentration data (if available) .....................29 16.2.6 Individual efficacy response data ............................................................29 16.2.7 Adverse event listings (each patient) ......................................................29 16.2.8. Listing of individual laboratory measurements by patient, when required by regulatory authorities ..........................................................29 16.3 CASE REPORT FORMS ........................................................................................29 16.3.1 CRFs for deaths, other serious adverse events and withdrawals for AE...................................................................................29 16.3.2 Other CRFs submitted .............................................................................29 16.4. INDIVIDUAL PATIENT DATA LISTINGS (US ARCHIVAL LISTINGS) .........29", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANNEX II", "definition": "PRINCIPAL OR COORDINATING INVESTIGATOR(S) SIGNATURE(S) OR SPONSOR\u2019S RESPONSIBLE MEDICAL OFFICER _______________ STUDY TITLE: ................................................................................. STUDY AUTHOR(S): ................................................................................. I have read this report and confirm that to the best of my knowledge it accurately describes the conduct and results of the study INVESTIGATOR: _______________________SIGNATURE(S) ____________________ OR SPONSOR\u2019S RESPONSIBLE", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANNEX V", "definition": "STUDY # (Data Set Identification) LISTING OF PATIENTS WHO DISCONTINUED THERAPY Centre:", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANNEX VI", "definition": "STUDY # (Data Set Identification) LISTING OF PATIENTS AND OBSERVATIONS EXCLUDED FROM EFFICACY ANALYSIS Centre:", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TITLE PAGE", "definition": "The title page should contain the following information: \u2212 study title \u2212 name of test drug/ investigational product \u2212 indication studied \u2212 if not apparent from the title, a brief (1 to 2 sentences) description giving design (parallel, cross-over, blinding, randomised) comparison (placebo, active, dose/response), duration, dose, and patient population \u2212 name of the sponsor \u2212 protocol identification (code or number) \u2212 development phase of study \u2212 study initiation date (first patient enrolled, or any other verifiable definition) \u2212 date of early study termination, if any \u2212 study completion date (last patient completed) \u2212 name and affiliation of principal or coordinating investigator(s) or sponsor\u2019s responsible medical officer \u2212 name of company/sponsor signatory (the person responsible for the study report within the company/sponsor. The name, telephone number and fax number of the company/sponsor contact persons for questions arising during review of the study report should be indicated on this page or in the letter of application.) \u2212 statement indicating whether the study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents \u2212 date of the report (identify any earlier reports from the same study by title and date). 2.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SYNOPSIS", "definition": "A brief synopsis (usually limited to 3 pages) that summarises the study should be provided (see Annex I of the guideline for an example of a synopsis format used in Europe). The synopsis should include numerical data to illustrate results, not just text or p-values. 3 Structure and Content of Clinical Study Reports 3. TABLE OF CONTENTS FOR THE INDIVIDUAL CLINICAL STUDY", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REPORT", "definition": "The table of contents should include: \u2212 the page number or other locating information of each section, including summary tables, figures and graphs; \u2212 a list and the locations of appendices, tabulations and any case report forms provided. 4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS A list of the abbreviations, and lists and definitions of specialised or unusual terms or measurements units used in the report should be provided. Abbreviated terms should be spelled out and the abbreviation indicated in parentheses at first appearance in the text. 5.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ETHICS", "definition": "5.1 INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB) It should be confirmed that the study and any amendments were reviewed by an Independent Ethics Committee or Institutional Review Board. A list of all IECs or IRBs consulted should be given in appendix 16.1.3 and, if required by the regulatory authority, the name of the committee Chair should be provided. 5.2 ETHICAL CONDUCT OF THE STUDY It should be confirmed that the study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki. 5.3 PATIENT INFORMATION AND CONSENT How and when informed consent was obtained in relation to patient enrolment, (e.g., at allocation, pre-screening) should be described. Representative written information for the patient (if any) and a sample patient consent form should be provided in appendix 16.1.3. 6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE The administrative structure of the study (e.g., principal investigator, coordinating investigator, steering committee, administration, monitoring and evaluation committees, institutions, statistician, central laboratory facilities, contract research organisation (C.R.O.), clinical trial supply management) should be described briefly in the body of the report. There should be provided in appendix 16.1.4 a list of the investigators with their affiliations, their role in the study and their qualifications (curriculum vitae or equivalent). A similar list for other persons whose participation materially affected the conduct of the study should also be provided in appendix 16.1.4. In the case of large trials with many investigators the above requirements may be abbreviated to consist of general statements of qualifications for persons carrying out particular roles in the study with only the name, degree and institutional affiliation and roles of each investigator or other participant. The listing should include: 4 Structure and Content of Clinical Study Reports a) Investigators b) Any other person carrying out observations of primary or other major efficacy variables, such as a nurse, physician's assistant, clinical psychologist, clinical pharmacist, or house staff physician. It is not necessary to include in this list a person with only an occasional role, e.g., an on-call physician who dealt with a possible adverse effect or a temporary substitute for any of the above c) The author(s) of the report, including the responsible biostatistician(s). Where signatures of the principal or coordinating investigators are required by regulatory authorities, these should be included in appendix 16.1.5 (see Annex II for a sample form). Where these are not required, the signature of the sponsor\u2019s responsible medical officer should be provided in appendix 16.1.5. 7.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTRODUCTION", "definition": "The introduction should contain a brief statement (maximum: 1 page) placing the study in the context of the development of the test drug/investigational product, relating the critical features of the study (e.g., rationale and aims, target population, treatment, duration, primary endpoints) to that development. Any guidelines that were followed in the development of the protocol or any other agreements/meetings between the sponsor/company and regulatory authorities that are relevant to the particular study, should be identified or described. 8.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "STUDY OBJECTIVES", "definition": "A statement describing the overall purpose(s) of the study should be provided. 9.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INVESTIGATIONAL PLAN", "definition": "9.1 OVERALL STUDY DESIGN AND PLAN - DESCRIPTION The overall study plan and design (configuration) of the study (e.g., parallel, cross- over) should be described briefly but clearly, using charts and diagrams as needed. If other studies used a very similar protocol, it may be useful to note this and describe any important differences. The actual protocol and any changes should be included as appendix 16.1.1 and a sample case report form (unique pages only; i.e., it is not necessary to include identical pages from forms for different evaluations or visits) as appendix 16.1.2. If any of the information in this section comes from sources other than the protocol, these should be identified. The information provided should include: \u2212 treatments studied (specific drugs, doses and procedures); \u2212 patient population studied and the number of patients to be included; \u2212 level and method of blinding/masking (e.g., open, double-blind, single-blind, blinded evaluators and unblinded patients and/or investigators); \u2212 kind of control(s) (e.g., placebo, no treatment, active drug, dose-response, historical) and study configuration (parallel, cross-over); \u2212 method of assignment to treatment (randomisation, stratification); \u2212 sequence and duration of all study periods, including pre-randomisation and post-treatment periods, therapy withdrawal periods and single- and double- blind treatment periods. When patients are randomised should be specified. 5 Structure and Content of Clinical Study Reports It is usually helpful to display the design graphically with a flow chart which includes timing of assessments (see Annexes IIIa and IIIb for an example); \u2212 any safety, data monitoring or special steering or evaluation committees; \u2212 any interim analyses. 9.2 DISCUSSION OF STUDY DESIGN, INCLUDING THE CHOICE OF", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANALYSES", "definition": "Any change in the conduct of the study or planned analyses (e.g., dropping a treatment group, changing the entry criteria or drug dosages, adjusting the sample size etc.) instituted after the start of the study should be described. The time(s) and reason(s) for the change(s), the procedure used to decide on the change(s), the person(s) or group(s) responsible for the change(s) and the nature and content of the data available (and to whom they were available) when the change was made should also be described, whether the change was documented as a formal protocol amendment or not (Personnel changes need not be included). Any possible implications of the change(s) for the interpretation of the study should be discussed briefly in this section and more fully in other appropriate sections of the report. In every section of the report, a clear distinction between conditions (procedures) planned in the protocol and amendments or additions should be made. In general, changes in planned analyses made prior to breaking the blind have limited implications for study interpretation. It is therefore particularly critical that the timing of changes relative to blind breaking and availability of outcome results be well characterised. 10.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "STUDY PATIENTS", "definition": "10.1 DISPOSITION OF PATIENTS There should be a clear accounting of all patients who entered the study, using figures or tables in the text of the report. The numbers of patients who were randomised, and who entered and completed each phase of the study, (or each week/month of the study) should be provided, as well as the reasons for all post-randomisation discontinuations, grouped by treatment and by major reason (lost to follow-up, adverse event, poor compliance etc.). It may also be relevant to provide the number of patients screened for inclusion and a breakdown of the reasons for excluding patients during screening, if this could help clarify the appropriate patient population for eventual drug use. A flow chart is often helpful (see Annexes IVa and IVb of the guideline for example). Whether patients are followed for the duration of the study, even if drug is discontinued, should be made clear. In appendix 16.2.1, there should also be a listing of all patients discontinued from the study after enrolment, broken down by centre and treatment group, giving a patient identifier, the specific reason for discontinuation, the treatment (drug and dose), 12 Structure and Content of Clinical Study Reports cumulative dose, (where appropriate), and the duration of treatment before discontinuation. Whether or not the blind for the patient was broken at the time of discontinuation should be noted. It may also be useful to include other information, such as critical demographic data (e.g., age, sex, race), concomitant medication, and the major response variable(s) at termination. See Annex V for an example of such a listing. 10.2", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PROTOCOL DEVIATIONS", "definition": "All important deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment should be described. In the body of the text, protocol deviations should be appropriately summarised by centre and grouped into different categories, such as: \u2212 those who entered the study even though they did not satisfy the entry criteria; \u2212 those who developed withdrawal criteria during the study but were not withdrawn; \u2212 those who received the wrong treatment or incorrect dose; \u2212 those who received an excluded concomitant treatment. In appendix 16.2.2, individual patients with these protocol deviations should be listed, broken down by centre for multicentre studies. 11.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DATA SETS ANALYSED", "definition": "Exactly which patients were included in each efficacy analysis should be precisely defined, e.g., all patients receiving any test drugs/investigational products, all patients with any efficacy observation or with a certain minimum number of observations, only patients completing the trial, all patients with an observation during a particular time window, only patients with a specified degree of compliance etc. It should be clear, if not defined in the study protocol, when, (relative to study unblinding), and how inclusion/exclusion criteria for the data sets analysed were developed. Generally, even if the applicant's proposed primary analysis is based on a reduced subset of the patients with data, there should also be for any trial intended to establish efficacy an additional analysis using all randomised (or otherwise entered) patients with any on-treatment data. There should be a tabular listing of all patients, visits and observations excluded from the efficacy analysis provided in appendix 16.2.3 (see Annex VI of the guideline for an example). The reasons for exclusions should also be analysed for the whole treatment group over time (see Annex VII of the guideline for an example). 11.2 DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS Group data for the critical demographic and baseline characteristics of the patients, as well as other factors arising during the study that could affect response, should be presented in this section and comparability of the treatment groups for all relevant characteristics should be displayed by use of tables or graphs in section 14.1. The data for the patient sample included in the \"all patients with data\" analysis should be given first. This can then be followed by data on other groups used in principal analyses, such as the \"per-protocol\" analysis or other analyses, e.g., groups defined by compliance, concomitant disease/therapy, or demographic/baseline characteristics. 13 Structure and Content of Clinical Study Reports When such groups are used, data for the complementary excluded group should also be shown. In a multicentre study where appropriate, comparability should be assessed by centre, and centres should be compared. A diagram showing the relationship between the entire sample and any other analysis groups should be provided. The critical variables will depend on the specific nature of the disease and on the protocol but will usually include: \u00be demographic variables \u2212 age \u2212 sex \u2212 race \u00be disease factors \u2212 specific entry criteria (if not uniform), duration, stage and severity of disease and other clinical classifications and sub-groupings in common usage or of known prognostic significance \u2212 baseline values for critical clinical measurements carried out during the study or identified as important indicators of prognosis or response to", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "therapy", "definition": "\u2212 concomitant illness at trial initiation, such as renal disease, diabetes,", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "heart failure", "definition": "\u2212 relevant previous illness \u2212 relevant previous treatment for illness treated in the study \u2212 concomitant treatment maintained, even if the dose was changed during the study, including oral contraceptive and hormone replacement therapy; treatments stopped at entry into the study period (or changed at study initiation) \u00be other factors that might affect response to therapy (e.g., weight, renin status, antibody levels, metabolic status) \u00be other possibly relevant variables (e.g., smoking, alcohol intake, special diets) and, for women, menstrual status and date of last menstrual period, if pertinent for the study. In addition to tables and graphs giving group data for these baseline variables, relevant individual patient demographic and baseline data, including laboratory values, and all concomitant medication for all individual patients randomised (broken down by treatment and by centre for multicentre studies) should be presented in by- patient tabular listings in appendix 16.2.4. Although some regulatory authorities will require all baseline data to be presented elsewhere in tabular listings, the appendix to the study report should be limited to only the most relevant data, generally the variables listed above. 14 Structure and Content of Clinical Study Reports 11.3 MEASUREMENTS OF TREATMENT COMPLIANCE Any measurements of compliance of individual patients with the treatment regimen under study and drug concentrations in body fluids should be summarised, analysed by treatment group and time interval, and tabulated in Appendix 16.2.5. 11.4 EFFICACY RESULTS AND TABULATIONS OF INDIVIDUAL PATIENT", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAFETY EVALUATION", "definition": "Analysis of safety-related data can be considered at three levels. First, the extent of exposure (dose, duration, number of patients) should be examined to determine the degree to which safety can be assessed from the study. Second, the more common adverse events, laboratory test changes etc. should be identified, classified in some reasonable way, compared for treatment groups, and analysed, as appropriate, for factors that may affect the frequency of adverse reactions/events, such as time dependence, relation to demographic characteristics, relation to dose or drug concentration etc. Finally, serious adverse events and other significant adverse events should be identified, usually by close examination of patients who left the study prematurely because of an adverse event, whether or not identified as drug related, or who died. The ICH Guideline on Clinical Safety Data Management, Definitions and Standards for Expedited Reporting defines serious adverse events as follows: a \"serious adverse event\" (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. 19 Structure and Content of Clinical Study Reports For the purpose of this guideline, \"other significant adverse events\" are marked haematological and other laboratory abnormalities and any adverse events that led to an intervention, including withdrawal of drug treatment, dose reduction or significant additional concomitant therapy. In the following sections, three kinds of analysis and display are called for: 1) summarised data, often using tables and graphical presentations presented in the main body of the report 2) listings of individual patient data, and 3) narrative statements of events of particular interest. In all tabulations and analyses, events associated with both test drug and control treatment should be displayed. 12.1", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "time of event", "definition": "\u2212 Drug concentration (if known) \u2212 Duration of test drug/investigational product treatment \u2212 Concomitant treatment during study. Any abbreviations and codes should be clearly explained at the beginning of the listing or, preferably, on each page. 12.3 DEATHS, OTHER SERIOUS ADVERSE EVENTS, AND OTHER SIGNIFICANT ADVERSE EVENTS Deaths, other serious adverse events, and other significant adverse events deserve special attention. 12.3.1 Listing of Deaths, other Serious Adverse Events and Other Significant", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Adverse Events", "definition": "Listings, containing the same information as called for in section 12.2.4 above, should be provided for the following events. 12.3.1.1", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SGPT", "definition": "AP..........X # 1 # 2", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "70 kg", "definition": "50 kg 400mg 300mg V1*", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RELATED TO SAFETY", "definition": "Vital signs, other physical findings, and other observations related to safety should be analysed and presented in a way similar to laboratory variables. If there is evidence of a drug effect, any dose-response or drug concentration-response relationship or relationship to patient variables (e.g., disease, demographics, concomitant therapy) should be identified and the clinical relevance of the observation described. Particular attention should be given to changes not evaluated as efficacy variables and to those considered to be adverse events. 12.6", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAFETY CONCLUSIONS", "definition": "The overall safety evaluation of the test drug(s)/investigational product(s) should be reviewed, with particular attention to events resulting in changes of dose or need for concomitant medication, serious adverse events, events resulting in withdrawal, and deaths. Any patients or patient groups at increased risk should be identified and particular attention paid to potentially vulnerable patients who may be present in small numbers, e.g., children, pregnant women, frail elderly, people with marked abnormalities of drug metabolism or excretion etc. The implication of the safety evaluation for the possible uses of the drug should be described. 13. DISCUSSION AND OVERALL CONCLUSIONS The efficacy and safety results of the study and the relationship of risks and benefit should be briefly summarised and discussed, referring to the tables, figures, and sections above as needed. The presentation should not simply repeat the description of results nor introduce new results. The discussion and conclusions should clearly identify any new or unexpected findings, comment on their significance and discuss any potential problems such as inconsistencies between related measures. The clinical relevance and importance of the results should also be discussed in the light of other existing data. Any specific benefits or special precautions required for individual subjects or at-risk groups and any implications for the conduct of future studies should be identified. Alternatively, such discussions may be reserved for summaries of safety and efficacy referring to the entire dossier (integrated summaries). 14. TABLES, FIGURES AND GRAPHS REFERRED TO BUT NOT", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INCLUDED IN THE TEXT", "definition": "Figures should be used to visually summarise the important results, or to clarify results that are not easily understood from tables. Important demographic, efficacy and safety data should be presented in summary figures or tables in the text of the report. However, if these become obtrusive because of size or number they should be presented here, cross-referenced to the text, along with supportive, or additional, figures, tables or listings. The following information may be presented in this section of the core clinical study report: 14.1", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DEMOGRAPHIC DATA", "definition": "Summary figures and tables 27 Structure and Content of Clinical Study Reports 14.2", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EFFICACY DATA", "definition": "Summary figures and tables 14.3", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAFETY DATA", "definition": "Summary figures and tables 14.3.1 Displays of Adverse Events 14.3.2 Listings of Deaths, Other Serious and Significant Adverse Events 14.3.3 Narratives of Deaths, Other Serious and Certain Other Significant Adverse", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Events", "definition": "14.3.4 Abnormal Laboratory Value Listing (Each Patient) 15.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REFERENCE LIST", "definition": "A list of articles from the literature pertinent to the evaluation of the study should be provided. Copies of important publications should be attached in an appendix (16.1.11 and 16.1.12). References should be given in accordance with the internationally accepted standards of the 1979 Vancouver Declaration on \"Uniform Requirements for Manuscripts Submitted to Biomedical Journals\" or the system used in \"Chemical Abstracts\". 16.", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "APPENDICES", "definition": "This section should be prefaced by a full list of all appendices available for the study report. Where permitted by the regulatory authority, some of the following appendices need not be submitted with the report but need to be provided only on request. The applicant should therefore clearly indicate those appendices that are submitted with the report. N.B. In order to have appendices available on request, they should be finalised by the time of filing of the submission. 16.1", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "STUDY INFORMATION", "definition": "16.1.1 Protocol and protocol amendments 16.1.2 Sample case report form (unique pages only) 16.1.3 List of IECs or IRBs (plus the name of the committee Chair if required by the regulatory authority) - Representative written information for patient and", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "sample consent forms", "definition": "16.1.4 List and description of investigators and other important participants in the study, including brief (1 page) CVs or equivalent summaries of training and experience relevant to the performance of the clinical study 16.1.5 Signatures of principal or coordinating investigator(s) or sponsor\u2019s responsible medical officer, depending on the regulatory authority's requirement 16.1.6 Listing of patients receiving test drug(s)/investigational product(s) from specific batches, where more than one batch was used 28 Structure and Content of Clinical Study Reports 16.1.7 Randomisation scheme and codes (patient identification and treatment assigned) 16.1.8 Audit certificates (if available) (see Annex IVa and IVb of the guideline) 16.1.9 Documentation of statistical methods 16.1.10 Documentation of inter-laboratory standardisation methods and quality assurance procedures if used 16.1.11 Publications based on the study 16.1.12 Important publications referenced in the report 16.2. PATIENT DATA LISTINGS 16.2.1 Discontinued patients 16.2.2 Protocol deviations 16.2.3 Patients excluded from the efficacy analysis 16.2.4 Demographic data 16.2.5 Compliance and/or drug concentration data (if available) 16.2.6 Individual efficacy response data 16.2.7 Adverse event listings (each patient) 16.2.8. Listing of individual laboratory measurements by patient, when required by regulatory authorities 16.3", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CASE REPORT FORMS", "definition": "16.3.1 CRFs for deaths, other serious adverse events and withdrawals for AE 16.3.2 Other CRFs submitted 16.4. INDIVIDUAL PATIENT DATA LISTINGS (US ARCHIVAL LISTINGS) 29 Structure and Content of Clinical Study Reports", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANNEX I", "definition": "Name of Sponsor/Company: Individual Study Table", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of the Dossier", "definition": "(For National Authority Use Only) Name of Finished Product: Volume: Name of Active Ingredient: Page: Criteria for evaluation: Efficacy: Safety: Statistical methods:", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUMMARY - CONCLUSIONS", "definition": "EFFICACY RESULTS: SAFETY RESULTS: CONCLUSION: Date of the report: 31 Structure and Content of Clinical Study Reports", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MEDICAL OFFICER", "definition": "AFFILIATION: _______________________ ______________________________ ______________________________ DATE: _______________________ 32 Structure and Content of Clinical Study Reports", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANNEX III a", "definition": "STUDY DESIGN AND SCHEDULE OF ASSESSMENTS", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Run-in", "definition": "5 mg 10 mg 5 mg 10 mg Test Drug/", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Product B", "definition": "5 mg 10 mg 5 mg 10 mg", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit", "definition": "-2 (-3) 1 0 2 3 3 6 4 9 5 12 6", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "1 = 14-20 days after visit 1", "definition": "2 = 1-7 days after the first exercise test 33 Structure and Content of Clinical Study Reports 34", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANNEX III b", "definition": "STUDY DESIGN AND SCHEDULE OF ASSESSMENTS", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dose 1", "definition": "1 2 3 4 R 11", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dose 3", "definition": "(7d) (7d) (7d) (7d) 5 6 7 8 9", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study Week", "definition": "-2 -1 0 1 2 3 4 5 6 8", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PATIENTS RECEIVING", "definition": "DOUBLE-BLIND MEDICATION N = 340", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Withdrawn", "definition": "ADVERSE EVENT (20) UNSAT. RESPONSE (32) etc. ...... etc. ...... 36 Structure and Content of Clinical Study Reports", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screening Failures", "definition": "Reasons: ___________ (300) ___________ (271) ___________ N= 8", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANY MEDICATION", "definition": "Reasons: _________ (2) _________ (4) _________ (2) N= 1724", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Placebo", "definition": "*The specific reaction leading to discontinuation (Repeat for other centres) 37 Structure and Content of Clinical Study Reports", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Reference Tables", "definition": "Summary: 38 Structure and Content of Clinical Study Reports", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANNEX VII", "definition": "STUDY # (Data Set Identification) NUMBER OF PATIENTS EXCLUDED FROM EFFICACY ANALYSIS Test Drug/Investigational Product N =", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Total", "definition": "Similar tables should be prepared for the other treatment groups. 39 Structure and Content of Clinical Study Reports", "sources": [ "ICH_E3.pdf" ], "source": "ICH_E3.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL", "definition": "REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USE", "definition": "ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) Current Step 4 version", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "dated 10 June 1996", "definition": "(including the Post Step 4 corrections) This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. E6(R1)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "E6", "definition": "Approval by the Steering Committee of Post-Step 4 editorial corrections. 10", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "June", "definition": "1996 E6(R1) GUIDELINE FOR GOOD CLINICAL PRACTICE ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 1 May 1996, this guideline is recommended for adoption to the three regulatory parties to ICH (This document includes the Post Step 4 corrections agreed by the Steering Committee on 10 June 1996)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Guideline for Good Clinical Practice", "definition": "8.4 After Completion or Termination of the Trial After completion or termination of the trial, all of the documents identified in sections 8.2 and 8.3 should be in the file together with the", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "iii", "definition": "GUIDELINE FOR GOOD CLINICAL PRACTICE", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Introduction", "definition": "Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor's independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected. The minimum list of essential documents which has been developed follows. The various documents are grouped in three sections according to the stage of the trial during which they will normally be generated: 1) before the clinical phase of the trial commences, 2) during the clinical conduct of the trial, and 3) after completion or termination of the trial. A description is given of the purpose of each document, and whether it should be filed in either the investigator/institution or sponsor files, or both. It is acceptable to combine some of the documents, provided the individual elements are readily identifiable. Trial master files should be established at the beginning of the trial, both at the investigator/institution\u2019s site and at the sponsor's office. A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files. Any or all of the documents addressed in this guideline may be subject to, and should be available for, audit by the sponsor\u2019s auditor and inspection by the regulatory authority(ies). 41 Guideline for Good Clinical Practice 8.2 Before the Clinical Phase of the Trial Commences During this planning stage the following documents should be generated and should be on file before the trial formally starts", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "GLOSSARY", "definition": "1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.2 Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.3 Amendment (to the protocol) See Protocol Amendment. 1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. 1.5 Approval (in relation to Institutional Review Boards) The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. 1.6", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit", "definition": "28 Guideline for Good Clinical Practice If or when sponsors perform audits, as part of implementing quality assurance, they should consider: 5.19.1 Purpose The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements. 5.19.2 Selection and Qualification of Auditors (a) The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct audits. (b) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor\u2019s qualifications should be documented. 5.19.3 Auditing Procedures (a) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports. (b) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s). (c) The observations and findings of the auditor(s) should be documented. (d) To preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings. (e) When required by applicable law or regulation, the sponsor should provide an audit certificate. 5.20", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit Certificate", "definition": "A declaration of confirmation by the auditor that an audit has taken place. 1.8", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit Report", "definition": "A written evaluation by the sponsor's auditor of the results of the audit. 2 Guideline for Good Clinical Practice 1.9", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit Trail", "definition": "Documentation that allows reconstruction of the course of events. 1.10 Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). 1.11 Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. 1.12 Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. 1.13 Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports). 1.14 Comparator (Product) An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. 1.15 Compliance (in relation to trials) Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. 1.16", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Confidentiality", "definition": "Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. 1.17", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contract", "definition": "A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. 1.18 Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. 3 Guideline for Good Clinical Practice 1.19 Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. 1.20 Contract Research Organization (CRO) A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. 1.21", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Direct Access", "definition": "Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor\u2019s proprietary information. 1.22", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Documentation", "definition": "All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. 1.23", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Essential Documents", "definition": "Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial). 1.24 Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. 1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. 1.26", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Impartial Witness", "definition": "A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject\u2019s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. 1.27 Independent Ethics Committee (IEC) An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable 4 Guideline for Good Clinical Practice opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline. 1.28", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Informed Consent", "definition": "A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. 1.29", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Inspection", "definition": "The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization\u2019s (CRO\u2019s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). 1.30 Institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted. 1.31 Institutional Review Board (IRB) An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. 1.32 Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses performed during the course of a trial. 1.33 Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. 1.34", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INVESTIGATOR", "definition": "4.1 Investigator's Qualifications and Agreements 4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies). 4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor. 4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. 4.1.4 The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies). 4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties. 4.2", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Monitoring", "definition": "5.18.1 Purpose The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected. (b) The reported trial data are accurate, complete, and verifiable from source documents. (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). 5.18.2 Selection and Qualifications of Monitors (a) Monitors should be appointed by the sponsor. (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor\u2019s qualifications should be documented. (c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor\u2019s SOPs, GCP, and the applicable regulatory requirement(s). 5.18.3 Extent and Nature of Monitoring The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. In general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigators\u2019 training and meetings, and extensive written guidance can assure appropriate conduct of the trial in accordance with GCP. Statistically controlled sampling may be an acceptable method for selecting the data to be verified. 5.18.4 Monitor's Responsibilities 26 Guideline for Good Clinical Practice The monitor(s) in accordance with the sponsor\u2019s requirements should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (a) Acting as the main line of communication between the sponsor and the investigator. (b) Verifying that the investigator has adequate qualifications and resources (see 4.1, 4.2, 5.6) and remain adequate throughout the trial period, that facilities, including laboratories, equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period. (c) Verifying, for the investigational product(s): (i) That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial. (ii) That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol specified dose(s). (iii) That subjects are provided with necessary instruction on properly using, handling, storing,", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Monitoring Report", "definition": "A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor\u2019s SOPs. 1.40", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Multicentre Trial", "definition": "A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. 1.41", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Nonclinical Study", "definition": "Biomedical studies not performed on human subjects. 1.42 Opinion (in relation to Independent Ethics Committee) The judgement and/or the advice provided by an Independent Ethics Committee (IEC). 1.43 Original Medical Record See Source Documents. 1.44", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocol", "definition": "A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. 1.45", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocol Amendment", "definition": "A written description of a change(s) to or formal clarification of a protocol. 1.46 Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). 6 Guideline for Good Clinical Practice 1.47 Quality Control (QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. 1.48", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Randomization", "definition": "The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. 1.49 Regulatory Authorities Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities. 1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity,", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "or", "definition": "corrections made to CRF after initial data were", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Source Data", "definition": "All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). 1.52", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Source Documents", "definition": "Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). 1.53", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sponsor", "definition": "8.4.7 FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES) To document completion of the trial", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sponsor-Investigator", "definition": "An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. 1.55 Standard Operating Procedures (SOPs) Detailed, written instructions to achieve uniformity of the performance of a specific function. 1.56", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subinvestigator", "definition": "Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator. 1.57 Subject/Trial Subject An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. 1.58 Subject Identification Code A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data. 1.59", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Site", "definition": "The location(s) where trial-related activities are actually conducted. 1.60 Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.61", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Procedures", "definition": "The IRB/IEC should establish, document in writing, and follow its procedures, which should include: 3.3.1 Determining its composition (names and qualifications of the members) and the authority under which it is established. 3.3.2 Scheduling, notifying its members of, and conducting its meetings. 3.3.3 Conducting initial and continuing review of trials. 3.3.4 Determining the frequency of continuing review, as appropriate. 3.3.5 Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC. 3.3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial. 3.3.7 Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or 11 Guideline for Good Clinical Practice administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see 4.5.2). 3.3.8 Specifying that the investigator should promptly report to the IRB/IEC: (a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4). (b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2). (c) All adverse drug reactions (ADRs) that are both serious and unexpected. (d) New information that may affect adversely the safety of the subjects or the conduct of the trial. 3.3.9", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "the", "definition": "investigator\u2019s trial staff ( may be combined with 8.2.19)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Records", "definition": "The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists. 4.", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Adequate Resources", "definition": "12 Guideline for Good Clinical Practice 4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period. 4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period. 4.2.3 The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely. 4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions. 4.3 Medical Care of Trial Subjects 4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. 4.3.2", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "regulatory", "definition": "authority(ies). 29 Guideline for Good Clinical Practice 5.21 Premature Termination or Suspension of a Trial If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s). 5.22 Clinical Trial/Study Reports Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.) 5.23", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Records and Reports", "definition": "4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports. 4.9.2 Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained. 4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections (see 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections. 4.9.4 The investigator/institution should maintain the trial documents as specified in Essential Documents for the Conduct of a Clinical Trial (see 8.) and as", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Progress Reports", "definition": "4.10.1 The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC. 4.10.2 The investigator should promptly provide written reports to the sponsor, the IRB/IEC (see 3.3.8) and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects. 4.11", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Safety Reporting", "definition": "4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC. 4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol. 4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports). 4.12 Premature Termination or Suspension of a Trial If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the applicable regulatory requirement(s), should inform the regulatory authority(ies). In addition: 4.12.1 If the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should inform the institution where applicable, and the investigator/institution should promptly inform the sponsor and the IRB/IEC, and should provide the sponsor and the IRB/IEC a detailed written explanation of the termination or suspension. 19 Guideline for Good Clinical Practice 4.12.2 If the sponsor terminates or suspends a trial (see 5.21), the investigator should", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Medical Expertise", "definition": "The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose. 5.4", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Design", "definition": "The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design, should include: 6.4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial. 6.4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages. 6.4.3 A description of the measures taken to minimize/avoid bias, including: (a) Randomization. (b) Blinding. 6.4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s). Also include a description of the dosage form, packaging, and labelling of the investigational product(s). 6.4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any. 6.4.6 A description of the \"stopping rules\" or \"discontinuation criteria\" for individual subjects, parts of trial and entire trial. 31 Guideline for Good Clinical Practice 6.4.7 Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any. 6.4.8 Maintenance of trial treatment randomization codes and procedures for breaking codes. 6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data. 6.5 Selection and Withdrawal of Subjects 6.5.1 Subject inclusion criteria. 6.5.2 Subject exclusion criteria. 6.5.3", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Financing", "definition": "The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution. 5.10 Notification/Submission to Regulatory Authority(ies) Before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator, if required by the applicable regulatory requirement(s)) should submit any required application(s) to the appropriate authority(ies) for review, acceptance, and/or permission (as required by the applicable regulatory requirement(s)) to begin the trial(s). Any notification/submission should be dated and contain sufficient information to identify the protocol. 5.11 Confirmation of Review by IRB/IEC 5.11.1 The sponsor should obtain from the investigator/institution: (a) The name and address of the investigator's/institution\u2019s IRB/IEC. (b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations. (c) Documented IRB/IEC approval/favourable opinion and, if requested by the sponsor, a current copy of protocol, written informed consent form(s) and any other written information to be provided to subjects, subject recruiting procedures, and documents related to payments and compensation available to the subjects, and any other documents that the IRB/IEC may have requested. 5.11.2 If the IRB/IEC conditions its approval/favourable opinion upon change(s) in any aspect of the trial, such as modification(s) of the protocol, written informed consent form and any other written information to be provided to subjects, and/or", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and", "definition": "absorption, plasma protein binding, distribution, and elimination). \u2212 Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form. \u2212 Population subgroups (e.g., gender, age, and impaired organ function). \u2212 Interactions (e.g., product-product interactions and effects of food). \u2212 Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s). (b) Safety and Efficacy A summary of information should be provided about the investigational product's/products' (including metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose response that were obtained from preceding trials in humans (healthy volunteers and/or patients). The implications of this information should be discussed. In cases where a number of clinical trials have been completed, the use of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear presentation of the data. Tabular summaries of adverse drug reactions for all the clinical trials (including those for all the studied indications) would be useful. Important differences in adverse drug 37 Guideline for Good Clinical Practice reaction patterns/incidences across indications or subgroups should be discussed. The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on the basis of prior experiences with the product under investigation and with related products. A description should also be provided of the precautions or special monitoring to be done as part of the investigational use of the product(s). (c) Marketing Experience The IB should identify countries where the investigational product has been marketed or approved. Any significant information arising from the marketed use should be summarised (e.g., formulations, dosages, routes of administration, and adverse product reactions). The IB should also identify all the countries where the investigational product did not receive approval/registration", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Record Access", "definition": "5.15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection. 5.15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection. 5.16", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Safety Information", "definition": "5.16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s). 5.16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the 25 Guideline for Good Clinical Practice safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favourable opinion to continue the trial. 5.17 Adverse Drug Reaction Reporting 5.17.1 The", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "concerned", "definition": "investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected. 5.17.2 Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. 5.17.3 The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s). 5.18", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Noncompliance", "definition": "5.20.1 Noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance. 5.20.2 If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution, the sponsor should terminate the investigator's/institution\u2019s participation in the trial. When an investigator's/institution\u2019s", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Multicentre Trials", "definition": "For multicentre trials, the sponsor should ensure that: 5.23.1 All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies), and given approval/favourable opinion by the IRB/IEC. 5.23.2 The CRFs are designed to capture the required data at all multicentre trial sites. For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data. 5.23.3 The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial. 5.23.4 All investigators are given instructions on following the protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs. 5.23.5 Communication between investigators is facilitated. 6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) The contents of a trial protocol should generally include the following topics. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator\u2019s Brochure. 6.1", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "General Information", "definition": "6.1.1 Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s). 6.1.2 Name and address of the sponsor and monitor (if other than the sponsor). 6.1.3 Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor. 6.1.4 Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when appropriate) for the trial. 30 Guideline for Good Clinical Practice 6.1.5 Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s). 6.1.6 Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator). 6.1.7 Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial. 6.2 Background Information 6.2.1 Name and description of the investigational product(s). 6.2.2 A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial. 6.2.3 Summary of the known and potential risks and benefits, if any, to human subjects. 6.2.4 Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). 6.2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). 6.2.6 Description of the population to be studied. 6.2.7 References to literature and data that are relevant to the trial, and that provide background for the trial. 6.3 Trial Objectives and Purpose A detailed description of the objectives and the purpose of the trial. 6.4", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "product", "definition": "(s ) pharmacological class and its expected position within this class (e.g. advantages), the rationale for performing research with the investigational product(s), and the anticipated prophylactic, therapeutic, or diagnostic indication(s). Finally, the introductory statement should provide the general approach to be followed in evaluating the investigational product. 7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation A description should be provided of the investigational product substance(s) (including the chemical and/or structural formula(e)), and a brief summary should be given of the relevant physical, chemical, and pharmaceutical properties. To permit appropriate safety measures to be taken in the course of the trial, a description of the formulation(s) to be used, including excipients, should be provided and justified if clinically relevant. Instructions for the storage and handling of the dosage form(s) should also be given. Any structural similarities to other known compounds should be mentioned. 35 Guideline for Good Clinical Practice 7.3.5 Nonclinical Studies Introduction:", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Treatment of Subjects", "definition": "6.6.1 The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial. 6.6.2 Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial. 6.6.3 Procedures for monitoring subject compliance. 6.7 Assessment of Efficacy 6.7.1 Specification of the efficacy parameters. 6.7.2 Methods and timing for assessing, recording, and analysing of efficacy parameters. 6.8", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Assessment of Safety", "definition": "6.8.1 Specification of safety parameters. 6.8.2 The methods and timing for assessing, recording, and analysing safety parameters. 6.8.3 Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses. 6.8.4 The type and duration of the follow-up of subjects after adverse events. 6.9", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Statistics", "definition": "32 Guideline for Good Clinical Practice 6.9.1 A description of the statistical methods to be employed, including timing of any planned interim analysis(ses). 6.9.2 The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects projected for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and clinical justification. 6.9.3 The level of significance to be used. 6.9.4 Criteria for the termination of the trial. 6.9.5 Procedure for accounting for missing, unused, and spurious data. 6.9.6 Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in protocol and/or in the final report, as appropriate). 6.9.7 The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed subjects, all eligible subjects, evaluable subjects). 6.10 Direct Access to Source Data/Documents The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data/documents. 6.11 Quality Control and Quality Assurance 6.12", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Ethics", "definition": "Description of ethical considerations relating to the trial. 6.13 Data Handling and Record Keeping 6.14 Financing and Insurance Financing and insurance if not addressed in a separate agreement. 6.15", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Publication Policy", "definition": "Publication policy, if not addressed in a separate agreement. 6.16", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Supplements", "definition": "(NOTE: Since the protocol and the clinical trial/study report are closely related, further relevant information can be found in the ICH Guideline for Structure and Content of Clinical Study Reports.) 33 Guideline for Good Clinical Practice 7. INVESTIGATOR\u2019S BROCHURE 7.1", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Title Page", "definition": "This should provide the sponsor's name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it supersedes, be provided. An example is given in Appendix 1. 7.2.2 Confidentiality Statement", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Summary", "definition": "A brief summary (preferably not exceeding two pages) should be given,", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "significant", "definition": "physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information available that is relevant to the stage of clinical development of the investigational product. 7.3.3", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "nonclinical", "definition": "pharmacology, toxicology, pharmacokinetic, and investigational product metabolism studies should be provided in summary form. This summary should address the methodology used, the results, and a discussion of the relevance of the findings to the investigated therapeutic and the possible unfavourable and unintended effects in humans. The information provided may include the following, as appropriate, if known/available: \u2022 Species tested \u2022 Number and sex of animals in each group \u2022 Unit dose (e.g., milligram/kilogram (mg/kg)) \u2022 Dose interval \u2022 Route of administration \u2022 Duration of dosing \u2022 Information on systemic distribution \u2022 Duration of post-exposure follow-up \u2022 Results, including the following aspects: \u2212 Nature and frequency of pharmacological or toxic effects \u2212 Severity or intensity of pharmacological or toxic effects \u2212 Time to onset of effects \u2212 Reversibility of effects \u2212 Duration of effects \u2212 Dose response Tabular format/listings should be used whenever possible to enhance the clarity of the presentation. The following sections should discuss the most important findings from the studies, including the dose response of observed effects, the relevance to humans, and any aspects to be studied in humans. If applicable, the effective and nontoxic dose findings in the same animal species should be compared (i.e., the therapeutic index should be discussed). The relevance of this information to the proposed human dosing should be addressed. Whenever possible, comparisons should be made in terms of blood/tissue levels rather than on a mg/kg basis. (a) Nonclinical Pharmacology A summary of the pharmacological aspects of the investigational product and, where appropriate, its significant metabolites studied in animals, should be included. Such a summary should incorporate studies that assess potential therapeutic activity (e.g. efficacy models, receptor binding, and specificity) as well as those that assess safety (e.g., special studies to assess pharmacological actions other than the intended therapeutic effect(s)). 36 Guideline for Good Clinical Practice (b) Pharmacokinetics and Product Metabolism in Animals A summary of the pharmacokinetics and biological transformation and disposition of the investigational product in all species studied should be given. The discussion of the findings should address the absorption and the local and systemic bioavailability of the investigational product and its metabolites,", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.2.2", "definition": "SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUBJECT", "definition": "- INFORMED CONSENT FORM (including all applicable translations) To document the informed consent", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "- ANY OTHER WRITTEN INFORMATION", "definition": "To document that subjects will be given appropriate written information (content and wording) to support their ability to give fully", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "- ADVERTISEMENT FOR SUBJECT", "definition": "RECRUITMENT (if used) To document that recruitment measures are appropriate and not coercive", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.2.4", "definition": "FINANCIAL ASPECTS OF THE TRIAL To document the financial agreement between the investigator/institution and the sponsor for", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INSURANCE STATEMENT", "definition": "(where required) To document that compensation to subject(s) for trial-related injury will be available", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.2.6", "definition": "SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.: - investigator/institution and sponsor - investigator/institution and CRO -", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "sponsor and CRO", "definition": "- investigator/institution and authority(ies) (where required) To document agreements", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.2.7", "definition": "DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB) /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING: - protocol and any amendments - CRF (if applicable) - informed consent form(s) - any other written information to be provided to the subject(s) - advertisement for subject recruitment (if used) - subject compensation (if any) - any other documents given approval/", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "favourable opinion", "definition": "To document that the trial has been subject to IRB/IEC review and given approval/favourable opinion. To identify the version number and date of the document(s)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "COMMITTEE COMPOSITION", "definition": "To document that the IRB/IEC is constituted in", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "(where", "definition": "required) 8.3.21 SUBJECT IDENTIFICATION CODE LIST To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any subject", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.2.11 NORMAL VALUE(S)/RANGE(S) FOR", "definition": "MEDICAL/ LABORATORY/TECHNICAL PROCEDURE(S) AND/OR TEST(S) INCLUDED IN THE PROTOCOL To document normal values and/or ranges of the", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "accreditation or", "definition": "- established quality control and/or external", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "quality assessment or", "definition": "- other validation (where required) To document that tests remain adequate throughout the trial period (see 8.2.12)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "applicable", "definition": "labelling regulations and appropriateness of instructions provided to the subjects", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.2.14 INSTRUCTIONS FOR HANDLING OF", "definition": "INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS (if not included in protocol or Investigator\u2019s Brochure) To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.2.15 SHIPPING RECORDS FOR", "definition": "INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SHIPPED", "definition": "To document identity, purity, and strength of investigational product(s) to be used in the trial", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TRIALS", "definition": "To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects' treatment", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "(third party if", "definition": "applicable) 8.2.19 PRE-TRIAL MONITORING REPORT To document that the site is suitable for the trial (may be combined with 8.2.20)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3", "definition": "During the Clinical Conduct of the Trial In addition to having on file the above documents, the following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available 8.3.1 INVESTIGATOR\u2019S BROCHURE UPDATES To document that investigator is informed in a timely manner of relevant information as it", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "informed consent form", "definition": "- any other written information provided to", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "subjects", "definition": "- advertisement for subject recruitment (if used) To document revisions of these trial related documents that take effect during trial", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.3", "definition": "DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB) /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING: - protocol amendment(s) - revision(s) of: - informed consent form - any other written information to be provided to the subject - advertisement for subject recruitment (if used) - any other documents given approval/favourable opinion - continuing review of trial (where required) To document that the amendment(s) and/or revision(s) have been subject to IRB/IEC review and were given approval/favourable opinion. To identify the version number and date of the document(s).", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "documents", "definition": "To document compliance with applicable regulatory requirements", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.5", "definition": "CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB- INVESTIGATOR(S) (see 8.2.10)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "UPDATES TO NORMAL", "definition": "VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/TEST(S) INCLUDED IN", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "THE PROTOCOL", "definition": "To document normal values and ranges that are revised during the trial (see 8.2.11)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.7", "definition": "UPDATES OF MEDICAL/LABORATORY/ TECHNICAL PROCEDURES/TESTS -", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DOCUMENTATION OF", "definition": "INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS SHIPMENT (see 8.2.15.)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.10 MONITORING VISIT REPORTS", "definition": "To document site visits by, and findings of, the", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "meeting notes", "definition": "- notes of telephone calls To document any agreements or significant", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "trial", "definition": "administration, protocol violations, trial conduct, adverse event (AE) reporting", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.12 SIGNED INFORMED CONSENT FORMS", "definition": "To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial. Also to document direct access permission (see 8.2.3)", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.13 SOURCE DOCUMENTS", "definition": "To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "(original)", "definition": "8.3.16 NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "to", "definition": "sponsor of serious adverse events and related reports in accordance with 4.11", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.17 NOTIFICATION BY SPONSOR AND/OR", "definition": "INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions in accordance with 5.17 and 4.11.1 and of other safety information in accordance with 5.16.2 and 4.11.2", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INFORMATION", "definition": "Notification by sponsor to investigators of safety information in accordance with 5.16.2", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.19 INTERIM OR ANNUAL REPORTS TO", "definition": "IRB/IEC AND AUTHORITY(IES) Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to authority(ies) in accordance with 5.17.3", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.23 INVESTIGATIONAL PRODUCTS", "definition": "ACCOUNTABILITY AT THE SITE To document that investigational product(s) have been used according to the protocol", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.24 SIGNATURE SHEET", "definition": "To document signatures and initials of all persons authorised to make entries and/or", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.3.25 RECORD OF RETAINED BODY FLUIDS/", "definition": "TISSUE SAMPLES (IF ANY) To document location and identification of retained samples if assays need to be repeated", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of", "definition": "investigational product(s) received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "unused", "definition": "investigational products by sponsor or at site", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CODE LIST", "definition": "To permit identification of all subjects enrolled in the trial in case follow-up is required. List should be kept in a confidential manner and for", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.4.4", "definition": "AUDIT CERTIFICATE (if available) To document that audit was performed", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REPORT", "definition": "To document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "8.4.6", "definition": "TREATMENT ALLOCATION AND DECODING DOCUMENTATION Returned to sponsor to document any decoding that may have occurred", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CLINICAL STUDY REPORT", "definition": "To document results and interpretation of trial", "sources": [ "ICH_E6.pdf" ], "source": "ICH_E6.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL", "definition": "REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USE", "definition": "ICH HARMONISED TRIPARTITE GUIDELINE STATISTICAL PRINCIPLES FOR CLINICAL TRIALS", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "dated 5 February 1998", "definition": "This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "E9", "definition": "STATISTICAL PRINCIPLES FOR CLINICAL TRIALS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 5 February 1998, this guideline is recommended for adoption to the three regulatory parties to ICH", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ii", "definition": "STATISTICAL PRINCIPLES FOR CLINICAL TRIALS I.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INTRODUCTION", "definition": "1.1 Background and Purpose The efficacy and safety of medicinal products should be demonstrated by clinical trials which follow the guidance in 'Good Clinical Practice: Consolidated Guideline' (ICH E6) adopted by the ICH, 1 May 1996. The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guideline. The proliferation of statistical research in the area of clinical trials coupled with the critical role of clinical research in the drug approval process and health care in general necessitate a succinct document on statistical issues related to clinical trials. This guidance is written primarily to attempt to harmonise the principles of statistical methodology applied to clinical trials for marketing applications submitted in Europe, Japan and the United States. As a starting point, this guideline utilised the CPMP (Committee for Proprietary Medicinal Products) Note for Guidance entitled 'Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorisations for Medicinal Products' (December, 1994). It was also influenced by 'Guidelines on the Statistical Analysis of Clinical Studies' (March, 1992) from the Japanese Ministry of Health and Welfare and the U.S. Food and Drug Administration document entitled 'Guideline for the Format and Content of the Clinical and Statistical Sections of a New Drug Application' (July, 1988). Some topics related to statistical principles and methodology are also embedded within other ICH guidelines, particularly those listed below. The specific guidance that contains related text will be identified in various sections of this document. E1A: The Extent of Population Exposure to Assess Clinical Safety E2A: Clinical Safety Data Management: Definitions and Standards for", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Expedited Reporting", "definition": "E2B: Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2C: Clinical Safety Data Management: Periodic Safety Update Reports for", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Bayesian Approaches", "definition": "Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g. treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference. Bias (Statistical & Operational) The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value. Bias introduced through deviations in conduct is referred to as 'operational' bias. The other sources of bias listed above are referred to as 'statistical'.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Blind Review", "definition": "The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalising the planned analysis.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Content Validity", "definition": "The extent to which a variable (e.g. a rating scale) measures what it is supposed to measure. 32 Statistical Principles for Clinical Trials", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Double-Dummy", "definition": "A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active).", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dropout", "definition": "A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Equivalence Trial", "definition": "A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Frequentist Methods", "definition": "Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realisations of the same experimental situation.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Full Analysis Set", "definition": "The set of subjects that is as close as possible to the ideal implied by the intention-to- treat principle. It is derived from the set of all randomised subjects by minimal and justified elimination of subjects. Generalisability, Generalisation The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. Global Assessment Variable A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. Intention-To-Treat Principle The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analysed as members of that group irrespective of their compliance to the planned course of treatment. 33 Statistical Principles for Clinical Trials Interaction (Qualitative & Quantitative) The situation in which a treatment contrast (e.g. difference between investigational product and control) is dependent on another factor (e.g. centre). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction the direction of the contrast differs for at least one level of the factor. Inter-Rater Reliability The property of yielding equivalent results when used by different raters on different occasions. Intra-Rater Reliability The property of yielding equivalent results when used by the same rater on different occasions.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Interim Analysis", "definition": "Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Meta-Analysis", "definition": "The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Multicentre Trial", "definition": "A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Non-Inferiority Trial", "definition": "A trial with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent (active or placebo control). Preferred and Included Terms In a hierarchical medical dictionary, for example MedDRA, the included term is the lowest level of dictionary term to which the investigator description is coded. The preferred term is the level of grouping of included terms typically used in reporting frequency of occurrence. For example, the investigator text \u201cPain in the left arm\u201d might be coded to the included term \u201cJoint pain\u201d, which is reported at the preferred term level as \u201cArthralgia\u201d. Per Protocol Set (Valid Cases, Efficacy Sample, Evaluable Subjects Sample) The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol violations. Safety & Tolerability The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology), vital signs, clinical adverse events (diseases, signs and symptoms), and 34 Statistical Principles for Clinical Trials other special safety tests (e.g. ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. Statistical Analysis Plan A statistical analysis plan is a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Superiority Trial", "definition": "A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control).", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Surrogate Variable", "definition": "A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Treatment Effect", "definition": "An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Treatment Emergent", "definition": "An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Statistician", "definition": "A statistician who has a combination of education/training and experience sufficient to implement the principles in this guidance and who is responsible for the statistical aspects of the trial. 35", "sources": [ "ICH_E9.pdf" ], "source": "ICH_E9.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Guidance for Industry", "definition": "Part 11, Electronic Records; Electronic Signatures \u2014 Scope", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and Application", "definition": "Division of Drug Information, HFD-240 Center for Drug Evaluation and Research (CDER) (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "or", "definition": "Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/~dms/guidance.html. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA)", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "I.", "definition": "INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 2 III. DISCUSSION.................................................................................................................... 3 A. Overall Approach to Part 11 Requirements................................................................................3 B. Details of Approach \u2013 Scope of Part 11 .......................................................................................4 1. Narrow Interpretation of Scope .....................................................................................................4 2. Definition of Part 11 Records ........................................................................................................5 C. Approach to Specific Part 11 Requirements ...............................................................................6 1. Validation.........................................................................................................................................6 2. Audit Trail........................................................................................................................................6 3. Legacy Systems ................................................................................................................................7 4. Copies of Records ............................................................................................................................7 5. Record Retention..............................................................................................................................8 IV. REFERENCES.................................................................................................................. 9 Contains Nonbinding Recommendations 1 Guidance for Industry1 1 Part 11, Electronic Records; Electronic Signatures \u2014 2", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Scope and Application", "definition": "3 4 5 6 This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It 7 does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 8 You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 9 and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 10 implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate 11 number listed on the title page of this guidance. 12 13 14 15 I.", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BACKGROUND", "definition": "59 60 In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by 61 FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten 62 signatures executed to electronic records as equivalent to paper records and handwritten 63 signatures executed on paper. These regulations, which apply to all FDA program areas, were 64 intended to permit the widest possible use of electronic technology, compatible with FDA's 65 responsibility to protect the public health. 66 67 After part 11 became effective in August 1997, significant discussions ensued among industry, 68 contractors, and the Agency concerning the interpretation and implementation of the regulations. 69 FDA has (1) spoken about part 11 at many conferences and met numerous times with an industry 70 coalition and other interested parties in an effort to hear more about potential part 11 issues; (2) 71 published a compliance policy guide, CPG 7153.17: Enforcement Policy: 21 CFR Part 11; 72 Electronic Records; Electronic Signatures; and (3) published numerous draft guidance 73 documents including the following: 74 4 See Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach at www.fda.gov/oc/guidance/gmp.html. Contains Nonbinding Recommendations 3 75 \u2022 21 CFR Part 11; Electronic Records; Electronic Signatures, Validation 76 \u2022 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms 77 \u2022 21 CFR Part 11; Electronic Records; Electronic Signatures, Time Stamps 78 \u2022 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic 79", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Records", "definition": "80 \u2022 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of 81", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Electronic Records", "definition": "82 83 Throughout all of these communications, concerns have been raised that some interpretations of 84 the part 11 requirements would (1) unnecessarily restrict the use of electronic technology in a 85 manner that is inconsistent with FDA's stated intent in issuing the rule, (2) significantly increase 86 the costs of compliance to an extent that was not contemplated at the time the rule was drafted, 87 and (3) discourage innovation and technological advances without providing a significant public 88 health benefit. These concerns have been raised particularly in the areas of part 11 requirements 89 for validation, audit trails, record retention, record copying, and legacy systems. 90 91 As a result of these concerns, we decided to review the part 11 documents and related issues, 92 particularly in light of the Agency's CGMP initiative. In the Federal Register of February 4, 93 2003 (68 FR 5645), we announced the withdrawal of the draft guidance for industry, 21 CFR 94 Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records. 95 We had decided we wanted to minimize industry time spent reviewing and commenting on the 96 draft guidance when that draft guidance may no longer represent our approach under the CGMP 97 initiative. Then, in the Federal Register of February 25, 2003 (68 FR 8775), we announced the 98 withdrawal of the part 11 draft guidance documents on validation, glossary of terms, time 99 stamps,5 maintenance of electronic records, and CPG 7153.17. We received valuable public 100 comments on these draft guidances, and we plan to use that information to help with future 101 decision-making with respect to part 11. We do not intend to re-issue these draft guidance 102 documents or the CPG. 103 104 We are now re-examining part 11, and we anticipate initiating rulemaking to revise provisions of 105 that regulation. To avoid unnecessary resource expenditures to comply with part 11 106 requirements, we are issuing this guidance to describe how we intend to exercise enforcement 107 discretion with regard to certain part 11 requirements during the re-examination of part 11. As 108 mentioned previously, part 11 remains in effect during this re-examination period. 109 110 111 III.", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Validation", "definition": "214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 requirements 216 for validation of computerized systems (\u00a7 11.10(a) and corresponding requirements in \u00a7 11.30). 217 Although persons must still comply with all applicable predicate rule requirements for validation 218 (e.g., 21 CFR 820.70(i)), this guidance should not be read to impose any additional requirements 219 for validation. 220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requirements. You should also consider the impact those systems might have on the accuracy, 224 reliability, integrity, availability, and authenticity of required records and signatures. Even if 225 there is no predicate rule requirement to validate a system, in some instances it may still be 226 important to validate the system. 227 228 We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record 230 integrity. For instance, validation would not be important for a word processor used only to 231 generate SOPs. 232 233 For further guidance on validation of computerized systems, see FDA\u2019s guidance for industry 234 and FDA staff General Principles of Software Validation and also industry guidance such as the 235 GAMP 4 Guide (See References). 236 237 2.", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit Trail", "definition": "238 239 The Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer-generated, time-stamped audit trails (\u00a7 11.10 (e), (k)(2) and any 241 corresponding requirement in \u00a711.30). Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., \u00a7 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring that changes to records do not 244 obscure previous entries. 245 246 Even if there are no predicate rule requirements to document, for example, date, time, or 247 sequence of events in a particular instance, it may nonetheless be important to have audit trails or 248 other physical, logical, or procedural security measures in place to ensure the trustworthiness and 249 Contains Nonbinding Recommendations 7 reliability of the records.6 We recommend that you base your decision on whether to apply audit 250 trails, or other appropriate measures, on the need to comply with predicate rule requirements, a 251 justified and documented risk assessment, and a determination of the potential effect on product 252 quality and safety and record integrity. We suggest that you apply appropriate controls based on 253 such an assessment. Audit trails can be particularly appropriate when users are expected to 254 create, modify, or delete regulated records during normal operation. 255 256 3.", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Legacy Systems7", "definition": "257 258 The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for systems that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below. 261 262 This means that the Agency does not intend to take enforcement action to enforce compliance 263 with any part 11 requirements if all the following criteria are met for a specific system: 264 265 \u2022 The system was operational before the effective date. 266 \u2022 The system met all applicable predicate rule requirements before the effective date. 267 \u2022 The system currently meets all applicable predicate rule requirements. 268 \u2022 You have documented evidence and justification that the system is fit for its intended use 269 (including having an acceptable level of record security and integrity, if applicable). 270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance. 274 275 4.", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Copies of Records", "definition": "276 277 The Agency intends to exercise enforcement discretion with regard to specific part 11 278 requirements for generating copies of records (\u00a7 11.10 (b) and any corresponding requirement in 279 \u00a711.30). You should provide an investigator with reasonable and useful access to records during 280 an inspection. All records held by you are subject to inspection in accordance with predicate 281 rules (e.g., \u00a7\u00a7 211.180(c), (d), and 108.35(c)(3)(ii)). 282 283 We recommend that you supply copies of electronic records by: 284 285 \u2022 Producing copies of records held in common portable formats when records are 286 maintained in these formats 287 \u2022 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References). 7 In this guidance document, we use the term legacy system to describe systems already in operation before the effective date of part 11. Contains Nonbinding Recommendations 8 In each case, we recommend that the copying process used produces copies that preserve the 291 content and meaning of the record. If you have the ability to search, sort, or trend part 11 292 records, copies given to the Agency should provide the same capability if it is reasonable and 293 technically feasible. You should allow inspection, review, and copying of records in a human 294 readable form at your site using your hardware and following your established procedures and 295 techniques for accessing records. 296 297 5.", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Record Retention", "definition": "298 299 The Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period (\u00a7 11.10 (c) and any corresponding requirement in \u00a711.30). Persons must still 302 comply with all applicable predicate rule requirements for record retention and availability (e.g., 303 \u00a7\u00a7 211.180(c),(d), 108.25(g), and 108.35(h)). 304 305 We suggest that your decision on how to maintain records be based on predicate rule 306 requirements and that you base your decision on a justified and documented risk assessment and 307 a determination of the value of the records over time. 308 309 FDA does not intend to object if you decide to archive required records in electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML). 312 Persons must still comply with all predicate rule requirements, and the records themselves and 313 any copies of the required records should preserve their content and meaning. As long as 314 predicate rule requirements are fully satisfied and the content and meaning of the records are 315 preserved and archived, you can delete the electronic version of the records. In addition, paper 316 and electronic record and signature components can co-exist (i.e., a hybrid8 situation) as long as 317 predicate rule requirements are met and the content and meaning of those records are preserved. 318 8 Examples of hybrid situations include combinations of paper records (or other nonelectronic media) and electronic records, paper records and electronic signatures, or handwritten signatures executed to electronic records. Contains Nonbinding Recommendations 9 319 IV.", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REFERENCES", "definition": "320 321 Food and Drug Administration References 322 323 1. Glossary of Computerized System and Software Development Terminology (Division of 324 Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 325 1995) (http://www.fda.gov/ora/inspect_ref/igs/gloss.html) 326 327 2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff 328 (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and 329 Research, 2002) (http://www.fda.gov/cdrh/comp/guidance/938.html) 330 331 3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use 332 in Medical Devices (FDA, Center for Devices and Radiological Health, 1999) 333 (http://www.fda.gov/cdrh/ode/guidance/585.html) 334 335 4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and 336 Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality 337 Systems Approach (FDA 2002) (http://www.fda.gov/oc/guidance/gmp.html) 338 339 340", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Industry References", "definition": "341 342 1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of 343 Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/) 344 345 2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology \u2013 Code of practice for 346 information security management (ISO/IEC, 2000) 347 348 3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices 349 (ISO, 2001) 350 351 352", "sources": [ "Part_11_Electronic_Records.pdf" ], "source": "Part_11_Electronic_Records.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Prepared by the", "definition": "CDISC Submission Data Standards Team", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Notes to Readers", "definition": "\u2022 This is the implementation guide for Human Clinical Trials corresponding to Version 1.2 of the CDISC Study Data Tabulation Model. \u2022 This Implementation Guide comprises version 3.1.2 of the CDISC Submission Data Standards and domain models.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Summary of Changes", "definition": "2004-07-14 3.1 Released version reflecting all changes and corrections identified during comment periods. 2005-08-26 3.1.1 Final Released version reflecting all changes and corrections identified during comment period. 2007-07-25 3.1.2 Draft for Public", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Comments", "definition": "co.xpt One record per comment per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Draft", "definition": "CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 2", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 4", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 6", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 8", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 10", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 12", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Topic", "definition": "Short name for the Parameter described in TSPARM. The value in TSPARMCD cannot be longer than 8 characters, nor can it start with a number. TSPARMCD cannot contain characters other than letters, numbers, or underscores. Examples: DESIGN, MASK, COMPTRT", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Synonym of --TRT", "definition": "Standardized or dictionary-derived name of the topic variable, --TRT, or the modified topic variable (--MODIFY), if applicable. Equivalent to the generic drug name in WHO Drug, or a term in SNOMED, ICD9, or other published or sponsor- defined dictionaries. --CAT", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Grouping", "definition": "Used to define a further categorization level for a group of --CAT values. Example: DIFFERENTIAL. --POS", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Record", "definition": "Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE. --LLOQ", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Variable Qualifier of", "definition": "--VAMT Units for the treatment vehicle. Examples: mL, puffs. --ADJ", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 14", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of --TERM", "definition": "Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA). --CAT", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of", "definition": "--TESTCD LOINC Code for the topic variable such as a lab test. --SPEC Specimen Material Type", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Qualifier", "definition": "Value of TSPARM. Example: 'ASTHMA' when TSPARM value is 'Trial Indications'. TSVAL cannot be null \u2013 a value is required for the record to be valid. The first 200 characters of TSVAL will be in TSVAL, then next 200 in TSVAL1, and continuing as needed to TSVALn.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Qualifier of", "definition": "--STRESN Indicates the lower limit of quantitation for an assay. Units will be those used for --STRESU. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and", "definition": "--STRESN Standardized units used for --STRESC and --STRESN. Example: mmol/L. --BODSYS", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 16", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char", "definition": "Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. Examples include CRF, ASSIGNED, or DERIVED. See Section 4.1.1.7.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Num", "definition": "Identifier Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same TSPARMCD, and can be used to join related records.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 18", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 20", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 22", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Standard Format", "definition": "3.1 STANDARD METADATA FOR DATASET CONTENTS AND", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ATTRIBUTES", "definition": "The SDTMIG provides standard descriptions of some of the most commonly used data domains, using the metadata attributes originally described in the CDISC Submission Metadata Model. The descriptive metadata attributes that should be included in a submission dataset definition file as applied in the domain models are: \u2022 The SDTMIG -standard variable name (standardized for all submissions, even though sponsors may be using other variable names internally in their operational database) \u2022 The SDTMIG -standard variable label \u2022 Expected data types (the SDTMIG uses character or numeric to conform to the data types consistent with SAS V5 transport file format, but Define.xml allows for more descriptive data types, such as integer or float) \u2022 The actual controlled terms and formats used by the sponsor (do not include the asterisk (*) included in the CDISC domain models to indicate when controlled terminology applies) \u2022 The origin or source of the data (e.g., CRF, derived - see definitions in Section 4.1.1.7) \u2022 The role of the variable in the dataset corresponding to the role in the SDTM if desired. Since these roles are predefined for all standard domains that follow the general observation classes, they do not need to be specified by sponsors in their Define data definition document for these domains.) \u2022 Any Comments provided by the sponsor that may be useful to the Reviewer in understanding the variable or the data in it. In addition to these metadata attributes, the CDISC domain models include three other shaded columns that are not sent to the FDA in order to assist sponsors in preparing their datasets \u2014 one column for notes relevant to the use of each variable, one to indicate how a variable is classified as a CDISC Core Variable (see Section 4.1.1.5), and one to provide references to relevant section of the SDTM or the SDTMIG. See the Define.xml specification for information about additional metadata attributes required in that standard. The domain models in Section 6 illustrate how to apply the SDTM when creating a specific domain dataset. In particular, these models illustrate the selection of a subset of the variables offered in one of the general observation classes along with applicable timing variables. The models also show how a standard variable from a general observation class should be adjusted to meet the specific content needs of a particular domain, including making the label more meaningful, specifying controlled terminology, and creating domain-specific notes and examples. Thus the domain models demonstrate not only how to apply the model for the most common domains, but also give insight on how to apply general model concepts to other domains not yet defined by CDISC. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Demographics", "definition": "dm.xpt One record per subject", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subject Elements", "definition": "se.xpt One record per actual Element", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subject Visits", "definition": "sv.xpt One record per actual visit per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Medications", "definition": "Interventions See Section 6.1.1.1, Assumption 1. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Exposure", "definition": "Interventions See Section 6.1.2.1, Assumption 1. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Substance Use", "definition": "Interventions See Section 6.1.3.1, Assumption 1 Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Adverse Events", "definition": "ae.xpt One record per adverse event", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Disposition", "definition": "ds.xpt One record per disposition status or protocol milestone per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Medical History", "definition": "mh.xpt One record per medical history", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Deviations", "definition": "dv.xpt One record per protocol", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DVSTDTC", "definition": "CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 24", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Events", "definition": "ce.xpt One record per event per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "One record per ECG", "definition": "observation per time point per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Results", "definition": "--VSORRESU, VSSTRESU Populated using a code value in the list of controlled terms, codelist VSRESU (C66770) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Tabulation", "definition": "STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL,", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Examination", "definition": "pe.xpt One record per body system or abnormality per visit per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Questionnaires", "definition": "qs.xpt One record per question per questionnaire per time point per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Characteristics", "definition": "sc.xpt One record per characteristic", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Vital Signs", "definition": "vs.xpt One record per vital sign measurement per time point per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Specimen", "definition": "mb.xpt One record per microbiology specimen finding per time point", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Test", "definition": "ms.xpt One record per microbiology susceptibility test (or other organism-related finding) per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Concentrations", "definition": "pc.xpt One record per time-point concentration or sample characteristic per analyte per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PCTPTREF", "definition": "CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Parameters", "definition": "pp.xpt One record per PK parameter per time-concentration profile per modeling method per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Findings", "definition": "cf.xpt One record per finding per subject per visit per time point", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Arms", "definition": "Trial Design See SDTM 3.2. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Elements", "definition": "Trial Design See SDTM 3.2. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Visits", "definition": "Trial Design See SDTM 3.2. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Exclusion Criteria", "definition": "Trial Design See SDTM 3.4. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Summary", "definition": "Trial Design See SDTM 3.5. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Related Records", "definition": "relrec.xpt One record per related record, group of records or datasets", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Qualifiers for", "definition": "[domain name] suppqual.xpt or supp--.xpt One record per IDVAR, IDVARVAL, and QNAM per", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QNAM", "definition": "\u2020Separate Supplemental Qualifier tables of the form supp--.xpt are recommended. See Section 8.4. 3.2.1.1", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PRIMARY KEYS", "definition": "Table 3.2.1 above shows examples of what a sponsor might submit as variables that comprise the primary key for SDTM datasets. Since the purpose of this column is to aid reviewers in understanding the structure of a dataset, sponsors should list all of the natural keys (see definition below) for the dataset. These keys should define uniqueness for records within a dataset, and may define a record sort order. The naming of these keys should be consistent with the description of the structure in the Structure column. For all the general-observation-class domains (and for some special-purpose domains), the --SEQ variable was created so that a unique record could be identified consistently across all of these domains via its use, along with STUDYID, USUBJID, DOMAIN. In most domains, --SEQ will be a surrogate key (see definition below) for a set of variables which comprise the natural key. In certain instances, a Supplemental Qualifier (SUPP--) variable might also contribute to the natural key of a record for a particular domain. See assumption 4.1.1.8 for how this should be represented, and for additional information on keys. A natural key is a piece of data (one or more columns of an entity) that uniquely identify that entity, and distinguish it from any other row in the table. A natural key is controlled from outside the database environment. The advantage of natural keys is that they exist already, and one does not need to introduce a new \u201cunnatural\u201d value to the data schema. One of the difficulties in choosing a natural key is that just about any natural key one can think of has the potential to change. Because they have business meaning, natural keys are effectively coupled to the business, and they may need to be reworked when business requirements change. An example of such a change in clinical trials CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 26", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Topic variable", "definition": "\u2022 Conforming to all business rules described in the CDISC Notes column and general and domain-specific assumptions. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Models", "definition": "4.1 GENERAL ASSUMPTIONS FOR ALL DOMAINS 4.1.1 GENERAL DOMAIN ASSUMPTIONS 4.1.1.1 REVIEW STUDY DATA TABULATION AND IMPLEMENTATION GUIDE Review the Study Data Tabulation Model as well as this Implementation Guide before attempting to use any of the individual domain models. See the Case Report Tabulation Data Definition Specification (define.xml), available on the CDISC website, for information about an xml representation of the Define data definition document. 4.1.1.2 RELATIONSHIP TO ANALYSIS DATASETS Specific guidance on preparing analysis datasets can be found in the CDISC Analysis Dataset Model General Considerations document, available at http://www.cdisc.org/models/adam/V2.0/index.html . 4.1.1.3 ADDITIONAL TIMING VARIABLES Additional Timing variables (Section 2.4.5) can be added as needed to a standard domain model based on the three general observation classes except where discouraged in Assumption 4.1.4.8 and specific domain assumptions. Timing variables can be added to special-purpose domains only where specified in the SDTMIG domain model assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC (described in Section 8). 4.1.1.4 ORDER OF THE VARIABLES The order of variables in the Define data definition document should reflect the order of variables in the dataset. The current order of variables in the CDISC domain models has been chosen to facilitate the review of the models and application of the models. Sponsors may thus wish to reorder Timing and Qualifier variables in order to place more emphasis on the most important variables, but are encouraged to apply a consistent variable-ordering scheme for all domains in a submission wherever possible. 4.1.1.5", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDISC CORE VARIABLES", "definition": "The concept of core variable is used both as a measure of compliance, and to provide general guidance to sponsors Three categories of variables are specified in the 'Core' column in the domain models: \u2022 A Required variable is any variable that is basic to the identification of a data record (i.e., essential key variables and a topic variable) or is necessary to make the record meaningful. Required variables must always be included in the dataset and cannot be null for any record. \u2022 An Expected variable is any variable necessary to make a record useful in the context of a specific domain. Columns for Expected variables must be present in each submitted dataset even if all values are null. Expected variables may contain some null values, but in most cases will not contain null values for every record; however, when no data has been collected for an expected variable, a null column should still be included in the dataset, and a comment should be included in the Define data definition document to state that data was not collected. \u2022 A Permissible variable should be used in a domain as appropriate when collected or derived. Except where restricted by specific domain assumptions, any SDTM Timing and Identifier variables, and any Qualifier variables from the same general observation class are permissible for use in a domain based on that general observation class. The Sponsor can decide whether a Permissible variable should be included as a column when all values for that variable are null. CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 28", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 30", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rotation of the hand", "definition": "\u2022 Method of measurement (X-ray / MRI) \u2022", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Machine Make", "definition": "CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Machine Model", "definition": "Trying to encapsulate all of this information within a unique value of a --TESTCD results in the creation of a potentially large number of test codes, with the eight-character values of --TESTCD becoming less intuitively meaningful. Additionally, multiple test codes are essentially representing the same test or measurement simply to accommodate attributes of a test within the --TESTCD value itself (e.g., to represent a body location at which a measurement was taken). Here is an example of what a compound --TESTCD might look like, it represents the measurement of erosion in the left metacarpal using an ultrasound technique to make the measurement:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LMCP1EA2", "definition": "This code breaks down as follows: LMCP1: represents the \u201cLocation\u201d of the test - \u201cLeft Metacarpal 1\u201d E: represents the \u201cTest\u201d \u2013 \u201cErosion\u201d A: represents the evaluation machine \u201cMake\u201d \u2013 \u201cAcme\u201d 2: represents the evaluation machine \u201cModel\u201d \u2013 \u201cu 2.1\u201d A second approach for depicting a unique test would be to use a generic (or simple) test code that requires associated qualifier variables to fully express the test detail. Using this approach in the above example, a generic --TESTCD value might be \u201cEROSION\u201d and the additional components of the compound test codes discussed above would be represented in a number of distinct qualifier variables. These may include domain variables (--LOC, --METHOD, etc.) and Supplemental Qualifier variables (QNAM.MAKE, QNAM.MODEL, etc.). Expressing the natural key becomes very important in this situation in order to communicate the variables that contribute to the uniqueness of a test. If a generic --TESTCD was used the following variables would be used to fully describe the test. The test is \u201cEROSION\u201d, the location is \u201cLeft MCP I\u201d, the method of measurement is \u201cUltrasound\u201d, the make of the ultrasound machine is \u201cACME\u201d and the model of the ultrasound machine is \u201cu 2.1\u201d. This domain includes both domain variables and Supplemental Qualifier variables that contribute to the natural key of each row and to describe the uniqueness of the test. --TESTCD --TEST --LOC --METHOD QNAM.MAKE QNAM.MODEL", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ACME", "definition": "U 2.1 CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 32", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CT1234-114-007", "definition": "004 211 4.1.2.4 CASE USE OF TEXT IN SUBMITTED DATA It is recommended that text data be submitted in upper case text. Exceptions may include long text data (such as comment text); values of --TEST in Findings datasets (which may be more readable in mixed case if used as labels in transposed views); and certain controlled terminology (see Section 4.1.4.3) that are already in mixed case. The Sponsor\u2019s Define data definition document may indicate as a general note or assumption whether case sensitivity applies to text data for any or all variables in the dataset. 4.1.2.5 CONVENTION FOR MISSING VALUES Missing values for individual data items should be represented by nulls. This is a change from previous versions of the SDTMIG, which allowed sponsors to define their conventions for missing values. Conventions for representing observations not done using the SDTM --STAT and --REASND variables are addressed in Section 4.1.5.1.1 and the individual domain models. 4.1.2.6 GROUPING VARIABLES AND CATEGORIZATION Grouping variables are Identifiers and Qualifiers that group records in the SDTM domains/datasets such as the --CAT and --SCAT variables assigned by sponsors to categorize data. For example, a lab record with LBTEST = 'SODIUM' might have LBCAT = 'CHEMISTRY' and LBSCAT = 'ELECTROLYTES'. Values for --CAT and --SCAT should not be redundant with the domain or dictionary classification provided by --DECOD and --BODSYS. 1. Hierarchy of Grouping Variables", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USUBJID", "definition": "Unique Subject Identifier Char Identifier Unique subject identifier within the submission.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "For the subject", "definition": "All records with the same USUBJID value are a group of records that describe that subject. b. Across subjects (records with different USUBJID values) 1. All records with the same STUDYID value are a group of records that describe that study 2. All records with the same DOMAIN value are a group of records that describe that domain 3. --CAT (Category) and --SCAT (Sub-category) values further subset groups within the domain. Generally, --CAT/--SCAT values have meaning within a particular domain. However, it is possible to use the same values for --CAT/--SCAT in related domains (e.g., MH and AE). When values are CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 34", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Non-medical reason", "definition": "_______________ The free text description should be stored in the SUPPEX dataset. \u2022 EXADJ=NONMEDICAL REASON \u2022 SUPPEX QNAM=EXADJOTH, QLABEL=Other Reason For Dose Adjustment, QVAL=PATIENT MISUNDERSTOOD INSTRUCTIONS \u0083 Note that QNAM references the \u201cparent\u201d variable name with the addition of \u201cOTH, \u201d one of the standard variable naming fragments for \u201cOther\u201d (see Appendix D). Likewise, the label is a modification of the parent variable label. When the CRF includes a list of values for a qualifier field that includes \"Other\" and the \"Other\" is supplemented with a \"Specify\" free text field, then the manner in which the free text \"Specify\" value is submitted will vary based on the sponsor's coding practice and analysis requirements. For example, consider a CRF that collects the anatomical location of administration (EXLOC) of a study drug given as an injection:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Left Thigh", "definition": "Other, Specify: _________________ CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 36", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RIGHT ABDOMEN", "definition": "\u2022 Occasionally, the sponsor may wish to use controlled terminology for the specify field as well as the location field. Suppose \u201cUPPER RIGHT ABDOMEN\u201d is coded to \u201cABDOMEN.\u201d If the sponsor wishes to submit both the controlled term as well as the original term, an additional record could be included in SUPPEX. In this case, the QNAM value might make use of the standard variable naming fragment for \u201cOriginal.\u201d \u0083 EXLOC=OTHER \u0083 SUPPEX QNAM=EXLOCOTH, QLABEL= Other Location Of Dose Administration, QVAL=ABDOMEN \u0083 SUPPEX QNAM=EXLOCOR, QLABEL=Original Location Of Dose Administration, QVAL=UPPER RIGHT ABDOMEN 2) If the sponsor wishes to maintain controlled terminology for EXLOC but will expand the terminology based on values seen in the specify field, then the value of EXLOC will reflect the sponsor\u2019s coding decision and SUPPEX could be used to store the verbatim text. \u2022 EXLOC=ABDOMEN \u2022 SUPPEX QNAM= EXLOCOTH, QVAL=UPPER RIGHT ABDOMEN \u0083 Note that the sponsor might choose a different value for EXLOC (e.g., UPPER ABDOMEN, TORSO) depending on the sponsor's coding practice and analysis requirements. 3) If the sponsor does not require that controlled terminology be maintained and wishes for all responses to be stored in a single variable, then EXLOC will be used and SUPPEX is not required. In this case, the sponsor might have provided the pre-specified choices as a convenience to the investigator. \u2022 EXLOC= UPPER RIGHT ABDOMEN 4.1.2.7.2 \u201cSPECIFY\u201d VALUES FOR RESULT QUALIFIER VARIABLES: When the CRF includes a list of values for a result field that includes \"Other\" and the \"Other\" is supplemented with a \"Specify\" free text field, then the manner in which the free text \"Specify\" value is submitted will vary based on the sponsor's coding practice and analysis requirements. For example, consider a CRF where the sponsor requests the subject's eye color:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Green", "definition": "Other, specify: ________ An investigator has selected \"OTHER\" and specified \"BLUEISH GRAY.\" As in the above discussion for non-result Qualifier values, the sponsor has several options for submission: 1) If the sponsor wishes to maintain controlled terminology in the standard result field and limit the terminology to the 5 pre-specified choices, then the free text is placed in --ORRES and the controlled terminology in --STRESC. \u2022 SCTEST=Eye Color, SCORRES=BLUEISH GRAY, SCSTRESC=OTHER 2) If the sponsor wishes to maintain controlled terminology in the standard result field, but will expand the terminology based on values seen in the specify field, then the free text is placed in --ORRES and the value of --STRESC will reflect the sponsor's coding decision. \u2022 SCTEST=Eye Color, SCORRES=BLUEISH GRAY, SCSTRESC=GRAY 3) If the sponsor does not require that controlled terminology be maintained, the verbatim value will be copied to --STRESC. \u2022 SCTEST=Eye Color, SCORRES=BLUEISH GRAY, SCSTRESC=BLUEISH GRAY CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Naproxen", "definition": "Other: ______ If ibuprofen and diclofenac were reported, the CM dataset would include the following: \u2022 CMTRT=IBUPROFEN, CMPRESP=Y \u2022 CMTRT=DICLOFENAC, CMPRESP=N Events: \u201cOther, Specify\u201d for events may be handled similarly to interventions. --TERM should be populated with the description of the event found in the specified text and --PRESP could be used to distinguish between pre-specified and free text responses. Findings: \u201cOther, Specify\u201d for tests may be handled similarly to interventions. --TESTCD and --TEST should be populated with the code and description of the test found in the specified text. 4.1.2.8 MULTIPLE VALUES FOR A VARIABLE 4.1.2.8.1 MULTIPLE VALUES FOR AN INTERVENTION OR EVENT TOPIC VARIABLE If multiple values are reported for a topic variable (i.e., --TRT in an Interventions general-observation-class dataset or -- TERM in an Events general-observation-class dataset), it is assumed that the sponsor will split the values into multiple records or otherwise resolve the multiplicity as per the sponsor\u2019s standard data management procedures. For example, if an adverse event term of \u201cHeadache and Nausea\u201d or a concomitant medication of \u201cTylenol and Benadryl\u201d is reported, sponsors will often split the original report into separate records and/or query the site for clarification. By the time of submission, the datasets should be in conformance with the record structures described in the SDTM IG. Note that the Disposition dataset (DS) should not have cases for splitting multiple topic values into separate records, since DS allows only one record per disposition status or protocol milestone per subject. See Section 6.2.2.1 for additional information. 4.1.2.8.2 MULTIPLE VALUES FOR A FINDING RESULT VARIABLE If multiple result values (--ORRES) are reported for a test in a Findings class dataset, multiple records should be submitted for that --TESTCD. Example: \u2022 EGTESTCD=RHYRATE, EGTEST=Rhythm and Rate, EGORRES=ATRIAL FIBRILLATION \u2022 EGTESTCD=RHYRATE, EGTEST=Rhythm and Rate, EGORRES=ATRIAL FLUTTER Note that in this case, the sponsor\u2019s operational database may have a result-sequence variable as part of the natural key. Some sponsors may elect to keep this variable in a Supplemental Qualifier record, while others may decide to use --SPID or --SEQ to replace it. Dependent variables such as result Qualifiers should never be part of the natural key. CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 38", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AELOC1", "definition": "Location of the Reaction 1", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AELOC2", "definition": "Location of the Reaction 2", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AELOC3", "definition": "Location of the Reaction 3", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CHEST", "definition": "In some cases, values for QNAM and QLABEL more specific than those above may be needed. For example, a sponsor might conduct a study with two study drugs (e.g., open-label study of Abcicin + Xyzamin), and has the investigator assess causality and describe action taken for each drug for the rash:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DOSE NOT CHANGED", "definition": "Note that in the latter case the label for standard variables AEREL and AEACN will have no indication that they pertain to Abcicin. This association must be clearly documented in the metadata and annotated CRF. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VARIABLES", "definition": "\u2022 For events such as AEs and Medical History, populate --DECOD with the dictionary\u2019s preferred term and populate --BODSYS with the preferred body system name. If a dictionary is multi-axial, the value in --BODSYS should represent the system organ class (SOC) used for the sponsor\u2019s analysis and summary tables, which may not necessarily be the primary SOC. \u2022 For concomitant medications, populate CMDECOD with the drug's generic name and populate CMCLAS with the drug class used for the sponsor\u2019s analysis and summary tables. If coding to multiple classes, follow assumption 4.1.2.8.1 or omit CMCLAS. In either case, no other intermediate levels or relationships should be stored in the dataset (although they may be provided in a Supplemental Qualifiers dataset). By knowing the dictionary and version used, the reviewer will be able to obtain intermediate levels in a hierarchy (as in MedDRA), or a drug\u2019s ATC codes (as in WHO Drug). The dictionary version should be listed in the Comments column of the Define data Definition document. The sponsor may be required to submit the dictionary if it is not already available to the reviewer. CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 40", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PESTRESC", "definition": "Character Result/Finding in Std. Format", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 42", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Precision", "definition": "ISO 8601 Date/Time 1 December 15, 2003 13:14:17 Complete date/time 2003-12-15T13:14:17 2 December 15, 2003 13:14", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Unknown seconds", "definition": "2003-12-15T13:14 3 December 15, 2003 13 Unknown minutes and seconds 2003-12-15T13 4 December 15, 2003", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Unknown day and time", "definition": "2003-12 6 2003 Unknown month , day, and time 2003 This date and date/time model also provides for imprecise or estimated dates, such as those commonly seen in Medical History. To represent these intervals while applying the ISO 8601 standard, it is recommended that the sponsor concatenate the date/time values (using the most complete representation of the date/time known) that describe the beginning and the end of the interval of uncertainty and separate them with a solidus as shown in the table below: Interval of Uncertainty ISO 8601 Date/Time 1 Between 10:00 and 10:30 on the Morning of December 15, 2003 2003-12-15T10:00/2003-12-15T10:30 2 After the first of this year (2003) until \"now\" (February 15, 2003, noon) 2003-01-01/2003-02-15T12:00 3 Between the first and the tenth of December, 2003 2003-12-01/2003-12-10 4 Sometime in the first half of 2003 2003-01-01/2003-06-30 Other uncertainty intervals may be represented by the omission of components of the date when these components are unknown or missing. As mentioned above, ISO 8601 represents missing intermediate components through the use of a hyphen where the missing component would normally be represented. This may be used in addition to \"appropriate right truncations\" for incomplete date/time representations. When components are omitted, the expected delimiters must still be kept in place and only a single hyphen is to be used to indicate an omitted component. Examples of this method of omitted component representation are shown in the table below: Date and Time as Originally", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Level of Uncertainty", "definition": "ISO 8601 Date/Time 1 December 15, 2003 13:15:17", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Complete date", "definition": "2003-12-15T13:15:17 2 December 15, 2003 ??:15 Unknown hour with known minutes 2003-12-15T-:15 3 December 15, 2003 13:??:17 Unknown minutes with known date, hours,", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and seconds", "definition": "2003-12-15T13:-:17 4 The 15th of some month in 2003, time", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "not collected", "definition": "Unknown month and time with known year", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and day", "definition": "2003---15 5 December 15, but can't remember the year, time not collected Unknown year with known month and day --12-15 6 7:15 of some unknown date Unknown date with known hour and", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "minute", "definition": "-----T07:15 CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PnW", "definition": "where: \u2022 [P] (duration designator): precedes the alphanumeric text string that represents the duration. NOTE: The use of the character P is based on the historical use of the term \"period\" for duration. \u2022 [n] represents a positive integer or zero \u2022 [W] is used as week designator, preceding a data Element that represents the number of calendar weeks within the calendar year (e.g., P6W represents 6 weeks of calendar time). The letter \"P\" must precede other values in the ISO 8601 representation of duration. The 'n' preceding each letter represents the number of Years, Months, Days, Hours, Minutes, Seconds, or the number of Weeks. As with the date/time format, 'T' is used to separate the date components from time components. Note that weeks cannot be mixed with any other date/time components such as days or months in duration expressions. As is the case with the date/time representation in --DTC, --STDTC or --ENDTC only the components of duration that are known or collected need to be represented. Also, as is the case with the date/time representation, if no time component is represented, the [T] time designator (in addition to the missing time) must be omitted in ISO 8601 representation. CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 44", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P3D", "definition": "6 Months 17 Days 3 Hours", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P6M17DT3H", "definition": "14 Days 7 Hours 57 Minutes", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "One-half hour", "definition": "PT0.5H 5 Days 12\u00bc Hours P5DT12.25H 4 \u00bd Weeks P4.5W Note that a leading zero is required with decimal values less than one. 4.1.4.3.2 INTERVAL WITH UNCERTAINTY When an interval of time is an amount of time (duration) following an event whose start date/time is recorded (with some level of precision, i.e. when one knows the start date/time and the duration following the start date/time), the correct ISO 8601 usage to represent this interval is as follows: YYYY-MM-DDThh:mm:ss/PnYnMnDTnHnMnS where the start date/time is represented before the solidus [/], the \"Pn\u2026\", following the solidus, represents a \u201cduration\u201d, and the entire representation is known as an \u201cinterval\u201d. NOTE: This is the recommended representation of elapsed time, given a start date/time and the duration elapsed. When an interval of time is an amount of time (duration) measured prior to an event whose start date/time is recorded (with some level of precision, i.e. where one knows the end date/time and the duration preceding that end date/time), the syntax is: PnYnMnDTnHnMnS/YYYY-MM-DDThh:mm:ss where the duration, \"Pn\u2026\", is represented before the solidus [/], the end date/time is represented following the solidus, and the entire representation is known as an \u201cinterval\u201d. 4.1.4.4 USE OF THE 'STUDY DAY' VARIABLES The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative day of the observation starting with the reference date as Day 1. They are determined by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC from the Demography domain). The Subject Reference Start Date (RFSTDTC) is designated as Study Day 1. The Study Day value is incremented by 1 for each date following RFSTDTC. Dates prior to RFSTDTC are decremented by 1, with the date preceding RFSTDTC designated as Study Day -1 (there is no Study Day 0). This algorithm for determining Study Day is consistent with how people typically describe sequential days relative to a fixed reference point, but creates problems if used for mathematical calculations because it does not allow for a Day 0. As such, Study Day is not CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Week 2 Unscheduled", "definition": "3.1 (Null) 17 4.1.4.6 REPRESENTING ADDITIONAL STUDY DAYS The SDTM allows for --DTC values to be represented as study days (--DY) relative to the RFSTDTC reference start date variable in the DM dataset, as described above in Section 4.1.4.4. The calculation of additional study days within subdivisions of time in a clinical trial may be based on one or more sponsor-defined reference dates not represented by RFSTDTC. In such cases, the Sponsor may define Supplemental Qualifier variables and the Define data definition document should reflect the reference dates used to calculate such study days. CDISC SDTM Implementation Guide (Version 3.1.2) 4.1.4.7 USE OF RELATIVE TIMING VARIABLES --STRF, --STTPT, --STRTPT, --ENRF, --ENTPT, AND --ENRTPT --STRF and --ENRF These variables --STRF and --ENRF were originally intended to represent timing of events and interventions relative to the study timeline when sponsors collected information such as 'PRIOR', 'ONGOING', or 'CONTINUING via check boxes on the CRF in lieu of collecting a date. However, it is acceptable to populate --STRF and --ENRF even if a date is collected. Some sponsors may automatically derive such information from collected dates for analysis or reporting purposes. --STRF is used to identify the start of an observation (Event, Intervention) or the time of collection (Finding) as being 'BEFORE', \u2018BEFORE/DURING\u2019, 'DURING', or 'AFTER' the sponsor-defined reference period. The sponsor- defined reference period is the continuous period of time defined by the discrete starting point (RFSTDTC) and the discrete ending point (RFENDTC) for each subject in Demographics. --ENRF is used to identify the end of the observation (Event, Intervention, or Finding) as being 'BEFORE', 'DURING', \u2018DURING/AFTER' or 'AFTER' the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by the discrete starting point (RFSTDTC) and the discrete ending point (RFENDTC) in Demographics. Both --STRF and --ENRF should be set to \u2018U\u2019 if the underlying value (e.g., \u2018PRIOR', 'ONGOING', or 'CONTINUING\u2019) was not collected for a subject, and is therefore unknown. Figure 4.1.4.7 below illustrates how to populate these variables in a CM domain for the standard reference period represented by RFSTDTC and RFENDTC (defined in the DM domain). ` Figure 4.1.4.7 Example of --STRF and --ENRF Variables for Concomitant Medications", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 46", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 48", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Collection Type", "definition": "--DTC --STDTC --ENDTC Single-Point Collection", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "4.1.4.9", "definition": "USE OF DATES AS RESULT VARIABLES Dates are generally used only as timing variables to describe the timing of an event, intervention, or collection activity, but there may be occasions when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. Note that using a date as a result to a Findings question is unusual and atypical, and should be approached with caution, but this situation may occasionally occur when a) a group of questions (each of which has a date response) is asked and analyzed together; or b) the event(s) and intervention(s) in question are not medically significant (often the case when included in questionnaires). Consider the following cases: \u2022", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Calculated due date", "definition": "\u2022 Date of last day on the job \u2022 Date of high school graduation CDISC SDTM Implementation Guide (Version 3.1.2) One approach to modeling these data would be to place the text of the question in --TEST and the response to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these date results do not contain the dates of medically significant events or interventions. Again, use extreme caution when storing dates as the results of findings. Remember, in most cases, these dates should be timing variables associated with a record in an Intervention or Events dataset. 4.1.4.10 REPRESENTING TIME POINTS Time points can be represented using the time point variables, --TPT, --TPTNUM, --ELTM, and the time point anchors, --TPTREF (text description) and --RFTDTC (the date/time). Note that time-point data will usually have an associated --DTC value. The interrelationship of these variables is shown in Figure 4.1.1.10 below. Figure 4.1.1.10 Values for these variables for Vital Signs measurements taken at 30, 60, and 90 minutes after dosing would look like the following.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DOSE ADMINISTRATION", "definition": "2006-08-01T08:00 2006-08-01T09:32 Note that the actual elapsed time is not an SDTM variable, but can be derived by an algorithm representing VSDTC-VSRFTDTC. When time points are used, --TPTNUM is required. Time points may or may not have an associated --TPTREF. Sometimes, --TPTNUM may be used as a key for multiple values collected for the same test within a visit; as such, there is no dependence upon an anchor such as --TPTREF, but there will be a dependency upon the VISITNUM. In such cases, VISITNUM will be required to confer uniqueness to values of --TPTNUM. If the protocol describes the scheduling of a dose using a reference intervention or assessment, then --TPTREF should be populated, even if it does not contribute to uniqueness. The fact that time points are related to a reference time point, and what that reference time point is, are important for interpreting the data collected at the time point. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 50", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PRE-DOSE", "definition": "1 1H 2 PERIOD 2, DAY 1 5", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PERIOD 1", "definition": "3 DAY 5, PM DOSE 4H 3", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PERIOD 2", "definition": "4 DAY 1, PM DOSE 4H 3 CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 52", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 54", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Chemistry", "definition": "229 mg/dL 0 199 229 229 11", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BLQ", "definition": "mg/L 0 0 mg/L 7", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Hematology", "definition": "5.9 10^9/L 4 11 5.9 5.9", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Not Done", "definition": "--STAT Populated using a code value in the list of controlled terms, codelist ND (C66789) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QS2", "definition": "HEALTH PERCEPTIONS (0-100) 82 82", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QSP11", "definition": "EXPECT HEALTH TO GET BETTER", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 56", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRF", "definition": "Case report form (sometimes case record form)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "COMMITTEE", "definition": "4.1.5.5 CLINICAL SIGNIFICANCE FOR FINDINGS OBSERVATION CLASS DATA SDTM provides two ways to handle assessments of clinical significance. Each has its place; they are not interchangeable. One is used to handle assessments of the clinical significance of a particular result (single record), CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 58", "definition": "CDISC, \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBSEQ", "definition": "48 1 Additional examples may be found in the domain examples such as the examples for Disposition/Adverse Event found in Section 6.2.2.2, Example 4, and all of the Pharmocokinetics examples in Section 6.3.10.5. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Value of", "definition": "--STAT Spontaneously reported event occurred Pre-specified event occurred", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DM", "definition": "--REAS Reason (include domain prefix) All general observation classes", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Exp", "definition": "* Indicates variable may be subject to controlled terminology A record in a SUPP-- dataset relates back to its parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID and IDVAR/IDVARVAL variables. An exception is SUPP-- dataset records that are related to Demography (DM) records , such as the Intent To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are sufficient to identify the unique parent record in DM (DM has one record per USUBJID). All records in the SUPP-- datasets must have a value for QVAL. Transposing source variables with missing/null values may generate SUPP-- records with null values for QVAL, causing the SUPP-- datasets to be extremely large. When this happens, the sponsor must delete the records where QVAL is null prior to submission. See Section 4.1.5.3 for information on representing information greater than 200 characters in length. CDISC SDTM Implementation Guide (Version 3.1.2) See Appendix C5 for controlled terminology for QNAM and QLABEL for some of the most common Supplemental Qualifiers. Additional QNAM values may be created as needed, following the guidelines provided in the CDISC Notes for QVAL. 8.4.2 SUBMITTING SUPPLEMENTAL QUALIFIERS IN SEPARATE DATASETS Beginning with the SDTMIG V3.1.1, the preferred approach is to submit Supplemental Qualifiers by domain rather than placing all of the supplemental information within one dataset. Therefore, it is recommended that sponsors who utilize the single SUPPQUAL approach begin to transition to individual SUPP-- datasets by domain. The single SUPPQUAL dataset option will be deprecated in the next (post V3.1.2) release. Following this convention for the Supplemental Qualifiers produces a one-to-one correspondence between a domain dataset and its Supplemental Qualifier dataset. In such cases, the set of Supplemental Qualifiers for each domain should be included in a separate dataset with the name SUPP-- where -- denotes the source domain which the Supplemental Qualifiers relate back to. For example, population flags and other demographic qualifiers would be placed in suppdm.xpt. Data may have been additionally split into multiple datasets (see Section 4.1.1.6.1, Splitting Domains). Sponsors must, however, choose only one approach for each study. Either individual SUPP-- datasets for each domain where needed should be submitted, or a single SUPPQUAL dataset for the entire study. In other words, separate SUPP-- datasets cannot be used with some domains and SUPPQUAL for the others. 8.4.3 SUPP-- EXAMPLES The examples below demonstrate how a set of SUPP-- datasets could be used to relate non-standard information to a parent domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Perm", "definition": "* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) 7.5.1 ASSUMPTIONS FOR TI DATASET 1. If inclusion/exclusion criteria were amended during the trial, then each complete set of criteria must be included in the TI domain. TIVERS is used to distinguish between the versions. 2. Protocol version numbers should be used to identify criteria versions, though there may be more versions of the protocol than versions of the inclusion/exclusion criteria. For example, a protocol might have versions 1, 2, 3, and 4, but if the inclusion/exclusion criteria in version 1 were unchanged through versions 2 and 3, and only changed in version 4, then there would be two sets of inclusion/exclusion criteria in TI, one for version 1, one for version 4. 3. Individual criteria do not have versions. If a criterion changes, it should be treated as a new criterion, with a new value for IETESTCD. If criteria have been numbered and values of IETESTCD are generally of the form INCL00n or EXCL00n, and new versions of a criterion have not been given new numbers, separate values of IETESTCD might be created by appending letters, e.g. INCL003A, INCL003B. 4. IETEST contains the text of the inclusion/exclusion criterion. However, since entry criteria are rules, the variable TIRL has been included in anticipation of the development of computer executable rules. 5. Assumption 5 for the IE Domain (Section 6.3.2.1) describes how to handle values of IETEST > 200 characters. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 60", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Timing", "definition": "1. Planned study day of VISIT. 2. Due to its sequential nature, used for sorting.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DMDY", "definition": "Study Day of Collection Num", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 62", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABC12301001", "definition": "001 2006-01-12 2006-03-10 01 JOHNSON, M 1948-12-13 57", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABC12301002", "definition": "002 2006-01-15 2006-02-28 01 JOHNSON, M 1955-03-22 50", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABC12301003", "definition": "003 2006-01-16 2006-03-19 01 JOHNSON, M 1938-01-19 68", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABC12301004", "definition": "004 01 JOHNSON, M 1941-07-02 5", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABC12302001", "definition": "001 2006-02-02 2006-03-31 02 GONZALEZ, E 1950-06-23 55", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABC12302002", "definition": "002 2006-02-03 2006-04-05 02 GONZALEZ, E 1956-05-05 49", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USA", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Check One", "definition": "American Indian or Alaska Native \u0000", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Asian", "definition": "\u0000 Black or African American \u0000 Native Hawaiian or Other Pacific", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HISPANIC OR LATINO", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Check all that apply", "definition": "American Indian or Alaska Native \u0000", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "White", "definition": "\u0000 Other, Specify: _____________________ \u0000 Row 1 (DM), Row 1 (SUPPDM) Subject 001 checked \u201cOther, Specify\u201d and entered \u201cJapanese\u201d which was mapped to \u201cAsian\u201d by the sponsor. Row 2 (DM), Row 2 (SUPPDM) Subject 002 checked \u201cOther, Specify\u201d and entered \u201cSwedish\u201d which was mapped to \u201cWhite\u201d by the sponsor.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Race 2", "definition": "AMERICAN INDIAN OR ALASKA NATIVE", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 64", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Non-Japanese", "definition": "\u0000 Black or African American \u0000 Native Hawaiian or Other Pacific", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 66", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Run-In", "definition": "2006-05-21 2006-05-26 CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 68", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CO", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 70", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INVESTIGATOR", "definition": "Note that the use of 10^9 as a unit is not a standard representation. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 72", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SE", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Req", "definition": "\u2022 * indicates variable may be subject to controlled terminology CDISC SDTM Implementation Guide (Version 3.1.2) 8.2.2 RELREC DATASET EXAMPLES Example 1: This example shows how to use the RELREC dataset to relate records stored in separate domains for USUBJID 123456 who had two lab tests performed (Rows 5 and 6) and took two concomitant medications (Rows 2 and 3) as the result of an adverse event (Rows 1 and 4). This example represents a situation in which the adverse event is related to both the concomitant medications and the lab tests, but there is no relationship between the lab values and the concomitant medications", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Example 1", "definition": "In the two rows of suppdm.xpt, population flags are defined as supplemental information to a subject\u2019s demographic data. IDVAR and IDVARVAL are null because the key variables STUDYID, RDOMAIN, and USUBJID are sufficient to identify a unique parent record in DM. suppdm.xpt: Supplemental Qualifiers for DM Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "COUNTRY", "definition": "Populated using a code value in the list of controlled terms, codelist COUNTRY (C66786) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 74", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Example 2", "definition": "The two rows of suppae.xpt add qualifying information to adverse event data (RDOMAIN=AE). IDVAR defines the key variable used to link this information to the AE data (AESEQ). IDVARVAL specifies the value of the key variable within the parent AE record that the SUPPAE record applies to. The remaining columns specify the supplemental variables\u2019 names (AESOTHC and AETRTEM), labels, values, , and who made the evaluation. suppae.xpt: Supplemental Qualifiers for AE Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DBA", "definition": "2006-05-03 2006-05-31 2 DOUBLE-BLIND TREATMENT 5 456 3", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "UNPLAN", "definition": "2006-05-31 2006-06-13 Drug B dispensed in error DOUBLE-BLIND TREATMENT 6 456 4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 76", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SV", "definition": "101 4.1 2006-02-07 2006-02-07 18 18", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SVSTDTC", "definition": "Start Date/Time of Visit Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SVENDTC", "definition": "End Date/Time of Visit Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screen", "definition": "Example Trial 6: Arms and Epochs Screen Trt A R A Trt A R A Trt A R A Trt A R A Follow", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DAY 1", "definition": "1 2001-02-01T18:30 1 600 min 12", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Week 1", "definition": "1999-06-19 8 (cont) 5.00 9.00", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Week 2", "definition": "1999-07-21 11 (cont) 10^3/uL 4 11", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Follow-up", "definition": "Decision not to treat further 4 weeks", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 78", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Observation Classes", "definition": "6.1 INTERVENTIONS 6.1.1 CONCOMITANT MEDICATIONS \u2014 CM cm.xpt, Concomitant Medications \u2014 Interventions, Version 3.1.2, July 25, 2007. One record per recorded intervention occurrence or constant-dosing interval per subject, Tabulation", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char CM", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF as an explicit line identifier or record identifier defined in the sponsor\u2019s operational database. Example: line number on a concomitant medication page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMTRT", "definition": "Reported Name of Drug, Med, or Therapy", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 80", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMCAT", "definition": "Category for Medication Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMROUTE", "definition": "Route of Administration Char (ROUTE)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 82", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "References", "definition": "MBORRESU Original Units Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Time Point", "definition": "Char BEFORE, AFTER, COINCIDENT, ONGOING, U", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMSTTPT", "definition": "Start Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMENTPT", "definition": "End Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 84", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VPA", "definition": "Example 3: Pre-specified concomitant medications using CMPRESP, CMOCCUR, CMSTAT, and CMREASND Sponsors often are interested in whether subjects are exposed to specific concomitant medications, and collect this information using a checklist. The example below is for a study that has a particular interest in the antidepressant medications that subjects use. For the study\u2019s purposes, the absence is just as important as the presence of a medication. This can be clearly shown by using CMOCCUR. In this example, CMPRESP shows that the subjects were specifically asked if they use any of three antidepressants (Zoloft, Prozac, or Paxil). The value of CMOCCUR indicates the response to the pre-specified medication question. CMSTAT indicates whether the response was missing for a pre-specified medication and CMREASND shows the reason for missing response. The medication details (e.g., dose, frequency) are not of interest.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 86", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char EX", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EXSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a CRF Page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EXTRT", "definition": "Name of Actual Treatment Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EXCAT", "definition": "Category for Treatment Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EXSCAT", "definition": "Subcategory for Treatment Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EXROUTE", "definition": "Route of Administration Char (ROUTE)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 88", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EXTPT", "definition": "Planned Time Point Name Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EX Definition", "definition": "a. The Exposure domain model records the details of a subject\u2019s exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject. Examples include but are not limited to placebo, active comparators, and investigational products. Treatments that are not protocol-specified should be recorded in the Concomitant Medication (CM) domain. b. This domain should contain one record per constant dosing interval per subject. \"Constant dosing interval\" is sponsor-defined, and may include any period of time that can be described in terms of a known treatment given at a consistent dose. E.g., for a study with once-a-week administration of a standard dose for 6 weeks, exposure may be represented with a single record per subject, spanning the entire treatment phase. Or if the sponsor monitors each treatment administration and deviations in treatment or dose occur, there could be up to six records (one for each weekly administration). 2. Categorization and Grouping a. EXCAT and EXSCAT may be used when appropriate to categorize treatments into categories and subcategories. For example, if a study contains several active comparator medications, EXCAT may be set to 'ACTIVE COMPARATOR.' Such categorization will not be useful in most studies, so these variables are permissible but not expected. 3. Exposure Treatment Description a. EXTRT captures the name of the investigational treatment and it is the topic variable. It is a required variable and must have a value. EXTRT should only include the treatment name and should not include dosage, formulation or other qualifying information. For example, \u201cASPIRIN 100MG TABLET\u201d is not a valid value for EXTRT. This example should be expressed as EXTRT= \u201cASPIRIN\u201d, EXDOSE= \u201c100\u201d, EXDOSU= \u201cMG\u201d, and EXDOSFRM= \u201cTABLET\u201d. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Timing Variables", "definition": "a. Relative timing assessments \"Prior\" or \u201cOngoing\u201d are common in the collection of Clinical Event information. CESTRF or CEENRF may be used when this timing assessment is relative to the study reference period for the subject represented in the Demographics dataset (RFENDTC). CESTRTPT with CESTTPT or CEENRTPT with CEENTPT may be used when \"Prior\" or \"Ongoing\" are relative to specific dates other than the start and end of the study reference period. See Section 4.1.4.7. b. Additional Timing variables may be used when appropriate. 5. Additional Events Qualifiers The following qualifiers would generally not be used in CE: --SER, --ACN, --ACNOTH, --REL, --RELNST, --OUT, --SCAN, --SCONG, --SDISAB, --SDTH, --SHOSP, --SLIFE, --SOD, --SMIE CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EXDOSFRM", "definition": "EXDOSFRQ EXDOSTOT EXROUTE EXSTDTC EXENDTC EXSTDY EXENDY 1 12345", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ORAL", "definition": "2004-07-10T07:30 2004-07-10T07:30 10 10 12 (cont) 800", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 90", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TABLET", "definition": "2002-07-02 2002-08-01 Increased due to suboptimal efficacy CDISC SDTM Implementation Guide (Version 3.1.2) Exposure Example 4: This is an example of a titration Exposure dataset for a study that gradually increases dosage while simultaneously evaluating efficacy and toleration of the treatment regimen. The schedule specifies that Drug A be administered twice daily starting with 100 mg for 3 days, then increase to 200 mg daily for 3 days, then increase further in 100-mg increments every three days until signs of intolerance are noted or no improvement in efficacy is observed. Row STUDYID DOMAIN USUBJID EXSEQ EXGRPID EXTRT EXDOSE EXDOSU", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 92", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char SU", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a Tobacco & Alcohol use CRF page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 94", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUROUTE", "definition": "Route of Administration Char (ROUTE)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUDUR", "definition": "Duration of Substance Use Char ISO 8601", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUSTTPT", "definition": "Start Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUENTPT", "definition": "End Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 96", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ONGOING", "definition": "2 (cont) 2006-01-01 2006-01-01 3 (cont) 2006-03-15", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BEFORE", "definition": "2003 4 (cont) 2006-03-15 2006-03-15 5 (cont) 2006-03-15 2006-03-15 6 (cont) Subject left office before CRF was completed 7 (cont) Subject left office before CRF was completed CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 98", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char AE", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AESPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. It may be pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on an Adverse Events page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AELOC", "definition": "Location of the Reaction Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AEPATT", "definition": "Pattern of Adverse Event Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AEOUT", "definition": "Outcome of Adverse Event Char (OUT)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 100", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AESOD", "definition": "Occurred with Overdose Char (NY)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AETOXGR", "definition": "Populated using a code value in the list of controlled terms, codelist TOXGR (C66784) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AEDUR", "definition": "Duration of Adverse Event Char ISO 8601", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Period", "definition": "--ROUTE Please see Section 4.1.4.7 \u201cUse of RELATIVE Timing Variables --STRF, --STTPT, --STRTPT, --ENRF, --ENTPT, AND --ENRTPT\u201d for specific regarding controlled terminology for these variables. Populated using a code value in the list of controlled terms, codelist STENRF (C66728) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AEENTPT", "definition": "End Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 102", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AE Structure", "definition": "The structure of the AE domain is one record per adverse event per subject. It is the sponsor's responsibility to define an event. This definition may vary based on the sponsor's requirements for characterizing and reporting product safety and is usually described in the protocol. For example, the sponsor may submit one record that covers an adverse event from start to finish. Alternatively, if there is a need to evaluate AEs at a more granular level, a sponsor may submit a new record when severity, causality, or seriousness changes or worsens. By submitting these individual records, the sponsor indicates that each is considered to represent a different event. The submission dataset structure may differ from the structure at the time of collection. For example, a sponsor might collect data at each visit in order to meet operational needs, but submit records that summarize the event and contain the highest level of severity, causality, seriousness, etc. Examples of dataset structure: 1. One record per adverse event per subject for each unique event. Multiple adverse event records reported by the investigator are submitted as summary records \u201ccollapsed\u201d to the highest level of severity, causality, seriousness, and the final outcome. 2. One record per adverse event per subject. Changes over time in severity, causality, or seriousness are submitted as separate events. Alternatively, these changes may be submitted in a separate dataset based on the CF model (see Section 6.3.11). 3. Other approaches may also be reasonable as long as they meet the sponsor's safety evaluation requirements and each submitted record represents a unique event. The domain-level metadata (See Section 3.2.2) should clarify the structure of the dataset. 8. Additional Events Qualifiers The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted because the AE domain contains only records for adverse events that actually occurred. See Assumption 4c above for information on how to deal with negative responses or missing responses to probing questions for pre-specified adverse events. CDISC SDTM Implementation Guide (Version 3.1.2) 6.2.1.2 EXAMPLES FOR ADVERSE EVENTS DOMAIN MODEL", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 1 and 2", "definition": "Show the following: -an example of modifying the reported term for coding purposes. The modified value is in AEMODIFY. -an example of the overall seriousness question AESER answered with an \u201cN\u201d and corresponding seriousness category variables (e.g., AESDTH, AESHOSP) left blank.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 3", "definition": "Shows a date/time in ISO 8601 representation where both the date and time were collected. Rows 4-5 Show where EGGRPID is used to group related results.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AE", "definition": "--CLSIG Clinically Significant (include domain prefix)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AEREL", "definition": "1 (cont) Nervous system disorders", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NOT APPLICABLE", "definition": "DEFINITELY NOT RELATED 2 (cont) Musculoskeletal and connective tissue disorders", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AEENRF", "definition": "1 (cont) RECOVERED/RESOLVED -1 -1 2 (cont) RECOVERED/RESOLVED 1 1 3 (cont) RECOVERING/RESOLVING", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 104", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 1and 2", "definition": "Show that nausea and vomiting were pre-specified on a CRF, as indicated by AEPRESP = \u201cY\u201d. The subject did not experience diarrhea, so no record for that term exists in the AE dataset.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 3", "definition": "Shows an example of an AE (headache) that is not pre-specified on a CRF as indicated by a blank for AEPRESP", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RELATED", "definition": "RECOVERED/RESOLVED 2005-10-13T13:00 2005-10-13T19:00 3 3 3 (cont) DOSE NOT CHANGED", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "POSSIBLY RELATED", "definition": "RECOVERED/RESOLVED 2005-10-21 2005-10-21 11 11", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Example 3", "definition": "This is an example of how the language used for a questionnaire might be represented. The parent domain (RDOMAIN) is QS, and IDVAR is QSCAT. QNAM holds the name of the Supplemental Qualifier variable being defined (QSLANG). The language recorded in QVAL applies to all of the subject\u2019s records where IDVAR (QSCAT) equals the value specified in IDVARVAL . In this case, IDVARVAL has values for two questionnaires (SF36 and ADAS) for two separate subjects. QVAL identifies the questionnaire language version (French or German) for each subject. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "disorders", "definition": "2005-10-29 19 CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Example 4", "definition": "The following example illustrates how data that may have been represented in an operational database as a single domain can be expressed using an Events general-observation-class dataset and a Supplemental Qualifiers dataset. Original Operational (non-SDTM) Dataset:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 1", "definition": "Shows extent of growth of Organism 1 found at Visit 1 in specimen 1 ( MBGRPID=1, Row 3 in MB example above). Rows 2, 3 Show results of susceptibility testing on Organism 1 found at Visit 1 in specimen 1 (MBGRPID=1, Row 3 in MB example above).", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 2-6", "definition": "Show the data in original units of measure in EGORRES, EGSTRESC, and EGSTRESN. See Section 4.1.5.1 for additional examples for the population of Result Qualifiers.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 106", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char DS", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DSSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a Disposition page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 108", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DS Definition", "definition": "a. The Disposition dataset provides an accounting for all subjects who entered the study and may include protocol milestones, such as randomization, as well as the subject's completion status or reason for discontinuation for the entire study or each phase or segment of the study, including screening and post-treatment follow up. Sponsors may choose which disposition events and milestones to submit for a study. See ICH E3, Section 10.1 for information about disposition events. 2. DS Description and Coding a. DSTERM and DSDECOD are required. DSDECOD values are drawn from sponsor-defined controlled terminology. The controlled terminology will depend on the value of DSCAT. When DSCAT=\"DISPOSITION EVENT\", DSTERM contains either \"COMPLETE\" or, if the subject did not complete, specific verbatim information about the disposition event. b. When DSTERM = \"COMPLETE\", DSDECOD = \"COMPLETE\". When DSTERM contains verbatim text, DSDECOD will contain a standard term from a controlled terminology list. For example, DSTERM = \"Subject moved\" might map to \"LOST TO FOLLOW-UP\" in the sponsor's controlled terminology. c. A sponsor may collect one disposition event for the trial as a whole, or they may collect disposition for each Epoch of the trial. When disposition is collected for each Epoch, the variable EPOCH should be included in the DS dataset. When EPOCH is populated for disposition events (records with DSCAT = DISPOSITION EVENT), EPOCH is the name of the Epoch whose disposition is described in the record. This is a subtly different meaning from that of EPOCH when it is used in other Events general-observation-class domains, where EPOCH, as a timing variable, is the name of the Epoch during which --STDTC occurs. The values of EPOCH are drawn from the Trial Arms domain, Section 7.2. d. When DSCAT=\"PROTOCOL MILESTONE\", DSTERM and DSDECOD will contain the same value drawn from the sponsor's controlled terminology. Examples of controlled terms include \"INFORMED CONSENT OBTAINED\" and \"RANDOMIZED.\" EPOCH should not be populated when DSCAT = 'PROTOCOL MILESTONE'. e. Events that are not disposition or milestone related are classified as an \u201cOTHER EVENT.\u201d \u201cTREATMENT UNBLINDED\u201d is a common example of \u201cOTHER EVENT.\u201d CDISC SDTM Implementation Guide (Version 3.1.2) 3.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 110", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DS", "definition": "456102 1 SUBJECT TAKING STUDY MED", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DISPOSITION EVENT", "definition": "2003-10-15 Disposition Example 3: Rows 1, 2 Subject completed the treatment and follow-up phase Rows 3, 5 Subject did not complete the treatment phase but did complete the follow-up phase.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 4", "definition": "Shows extent of growth of Organism 2 found at Visit 1 in specimen 1 (MBGRPID=2, Row 4 in MB example above). Rows 5, 6 Show results of susceptibility testing on Organism 2 found at Visit 1 in specimen 1 (MBGRPID=2, Row 4 in MB example above).", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 112", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PHASE", "definition": "2003-09-29 2003-09-29 Adverse Event (AE) Dataset:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AESMIE", "definition": "1 (cont) DEFINITELY NOT RELATED", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RELREC Dataset", "definition": "Rows 1-5 identify the records that participate in the relationship with RELID=1. Rows 1-4 identify the four CF records, and Row 5 identifies the AE record. Rows 6-8 identify the records that participate in the relationship with RELID=2. Rows 6 and 7 identify the two CF records, and Row 8 identifies the AE record.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AESEQ", "definition": "2 2 CDISC SDTM Implementation Guide (Version 3.1.2) 7 Trial Design Datasets 7.1", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 114", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char MH", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MHSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a Medical History page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MHENTPT", "definition": "End Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 116", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Value of MHSTAT", "definition": "Spontaneously reported event occurred Pre-specified event occurred", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 1-3", "definition": "MHENRF has been populated based on the response to the \"Ongoing at Study Start\" question on the General Medical History CRF. If \"Yes\" is specified, MHENRF=\"DURING/AFTER;\" if \"No\" is checked, MHENRF=\"PRIOR.\" See Section 4.1.4.7 for further guidance on using --STRF and --ENRF.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 5", "definition": "Shows the organism assigned as ORG02 is still present in Specimen 2 at Visit 2.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Example 1 data", "definition": "Row STUDYID DOMAIN USUBJID MHSEQ", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MH", "definition": "101003 4 TRANSIENT ISCHEMIC ATTACK", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 118", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 1-10", "definition": "MHPRESP values of 'Y' indicate that each condition was pre-specified on the CRF. The presence or absence of a condition is documented with MHOCCUR. The data are collected as part of the Screening visit. Rows 1-3, 7, 9 The absence of a condition is documented with MHOCCUR. Rows 4-6, 8 The presence of a condition is documented with MHOCCUR.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 10", "definition": "The subject had cholesterol measured. The normal range for this test is <200 mg/dL. The value <200 may not be used in the normal range variables LBORNRHI or LBSTNRHI; however, a sponsor may decide, for example, to enter '0' into LBORNRLO and '199' in LBORNRHI. The sponsor must define the appropriate value for all of the normal range variables. Row 1, 6 The SUPPLB dataset example shows clinical significance assigned by the investigator for test results where LBNRIND (reference range indicator) is populated. Lab Example 1 LB dataset", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 5-9", "definition": "MHCAT indicates that these terms were reported on the RISK FACTORS page. These terms are not coded.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 5- 8", "definition": "MHPRESP values of 'Y' indicate that each risk factor was pre-specified on the CRF. MHOCCUR is populated with Y or N corresponding to the CRF response to the questions for the 4 pre-specified risk factors.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 9", "definition": "Shows the proper use of the LBSTAT variable to indicate \"NOT DONE\", where a reason was collected when a test was not done.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 120", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char DV", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DVSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a CRF page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 1 and 3", "definition": "Show examples of a TREATMENT DEVIATION type of protocol deviation. This type of deviation is categorized as MAJOR (DVCAT) for this study.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 2", "definition": "Shows the proper use of the STAT variable to indicate \"NOT DONE\", and when PEREASND is used to indicate why a body system (PETEST) was not examined.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 4 and 5", "definition": "Shows an example of VISIT OUTSIDE WINDOW, which is considered to be a MINOR (DVCAT) deviation for this study. Row STUDYID DOMAIN USUBJID DVSEQ", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DV", "definition": "123103 4 VISIT 3 MORE THAN 3 DAYS OUT OF", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 122", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char CE", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CESPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a CRF page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CECAT", "definition": "Category for Clinical Event Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CEOCCUR", "definition": "Clinical Event Occurrence Char (NY)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 124", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CESTTPT", "definition": "Start Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CEENTPT", "definition": "End Reference Time Point Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Value of CESTAT", "definition": "Spontaneously reported event occurred Pre-specified event occurred", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Conjunctivitis", "definition": "Example 1 Data: Rows 1-3 Show records for clinical events for which start dates were recorded. Since conjunctivitis was not observed, no start date was recorded and there is no CE record.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 126", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Diarrhea", "definition": "Row 1 shows the record for a Nausea probing question answered \"Yes\". Since Nausea is a pre-specified adverse event, the AE domain will contain a record for this event. Row 2 shows the record for a Vomiting probing question answered \"No\". Row 3 shows the record for a Diarrhea probing question with an answer of \"NOT DONE\".", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SEVERE", "definition": "2005-10-09 2005-10-11 CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 128", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char EG", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EGSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the ECG page.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EGPOS", "definition": "ECG Position of Subject Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EGXFN", "definition": "ECG External File Name Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 130", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EGTPT", "definition": "Planned Time Point Name Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 1-6", "definition": "Show how ECG measurements are represented.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 2-10", "definition": "Show how EGCAT could be used to group the intervals and the findings.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 5-6", "definition": "Show QTCB and QTCF. The data shows a \u201cY\u201d in the EGDRVFL column since these results are derived by the sponsor in this example.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 7-10", "definition": "Show how ECG findings are represented.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 11", "definition": "Shows derived records. Notice how QSORRES is blank for derived records because there is no corresponding text value for the numeric value shown (see Section 4.1.1.7.1). In this study, QSTPTNUM is an arbitrary number, sponsor defined to aid in sorting.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 12", "definition": "The TEST \"Interpretation\" (i.e., the interpretation of the ECG strip as a whole), is \"ABNORMAL \". CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screening 1", "definition": "2003-04-15T11:58 -36 ECG Example 1 SUPPEG dataset", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 132", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SCREEN I", "definition": "-2 2003-11-26 -2 2 (cont)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SCREEN II", "definition": "-1 2003-11-27 -1 3 (cont)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DAY 10", "definition": "10 2003-12-07T09:02 10 4 (cont)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DAY 15", "definition": "15 2003-12-12 15 CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 134", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char IE", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "IESPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Inclusion or Exclusion criteria number from CRF.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INCL03", "definition": "Acceptable mammogram from local radiologist?", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WEEK -8", "definition": "-56 1999-01-12 -56 4 (cont) 1", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 136", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char LB", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBSCAT", "definition": "Subcategory for Lab Test Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 138", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBTOXGR", "definition": "Standard Toxicity Grade Num *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 140", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 2-4", "definition": "Show two records for Alkaline Phosphatase done at the same visit, one day apart. Row 4 shows how to create a derived record (average of the records 2 and 3) and flagged derived (LBDRVFL = \u201cY\u201d) and as the record to use as baseline (LBBLFL = \u201cY\u201d).", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 6 and 7", "definition": "Show a suggested use of the LBSCAT variable. It could be used to further classify types of tests within a laboratory panel (i.e., \u201cDIFFERENTIAL\u201d).", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DIFFERENTIAL", "definition": "5.1 10^9/L 2 8 5.1 5.1 8", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Urinalysis", "definition": "7.5 5.0 9.0 7.5 9", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBDTC", "definition": "1 (cont) g/dL 3.5 5", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 1", "definition": "Shows an example of a pre-dose urine collection interval (from 4 hours prior to dosing until 15 minutes prior to dosing) with a negative value for LBELTM that reflects the end of the interval in reference to the fixed reference LBTPTREF, the date of which is recorded in LBRFTDTC.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 2 and 3", "definition": "Show an example of post-dose urine collection intervals with values for LBELTM that reflect the end of the intervals in reference to the fixed reference LBTPTREF, the date of which is recorded in LBRFTDTC.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VISITNUM", "definition": "Row 1 (cont) 0.38 0.38 mmol/L 0.1 0.8", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "INITIAL DOSING", "definition": "2 Row 3 (cont) 0.5 0.5 mmol/L 0.1 0.8", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBRFTDTC", "definition": "Row 1 (cont) 1999-06-19T04:00 1999-06-19T07:45", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dosing", "definition": "1999-06-19T08:00 LB Example 3: This is an example of pregnancy test records, one with a result and one with no result because the test was not performed due to the subject being male.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 142", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char PE", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PESPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a CRF.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PECAT", "definition": "Category for Examination Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 144", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VISITDY", "definition": "Planned Study Day of Visit Num", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PEDTC", "definition": "Date/Time of Examination Char ISO 8601", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PEDY", "definition": "Study Day of Examination Num", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 4-6", "definition": "Show how PESPID is used to show the sponsor-defined identifier, which in this case is a sequence number used for identifying abnormalities within a body system.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rows 4-7", "definition": "Show how PESTRESC is populated if abnormality is dictionary coded. Rows 8, 13 Show how the PECAT variable can be used to indicate a different type of physical examination. In this case, the ophthalmologic examination may have been collected in a separate dataset in the operational database.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BASELINE", "definition": "1 1999-06-19 1 12 (cont)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VISIT 1", "definition": "35 1999-07-21 33 CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 146", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char QS", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QSSCAT", "definition": "Subcategory for Question Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QSORRES", "definition": "Finding in Original Units Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 148", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 150", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "GH11C", "definition": "Expect health to get worse", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RP4A", "definition": "Phys. Health-cut down time spent", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RP4C", "definition": "Phys. Health-limit kind of work", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SCREENING", "definition": "-14 2001-03-20 -10 1 11 (cont) 9", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 152", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char SC", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SCSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Perm SDTM 2.2.4 SCTESTCD Subject Characteristic", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 154", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SCDY", "definition": "Study Day of Examination Num", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CQH", "definition": "1999-06-14 CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 156", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Identifier", "definition": "Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database. Example: Line number on a CRF. Perm SDTMIG 2.4.4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor\u2019s operational database.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSCAT", "definition": "Category for Vital Signs Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSSCAT", "definition": "Subcategory for Vital Signs Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 158", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSDY", "definition": "Study Day of Vital Signs", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSTPT", "definition": "Planned Time Point Name Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 14", "definition": "Shows a value collected in one unit, but converted to selected standard unit.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 15", "definition": "Shows the proper use of the STAT variable to indicate \"NOT DONE\" where a reason was collected when a test was not done.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSPOS", "definition": "VSORRES VSORRESU VSSTRESC VSSTRESN VSSTRESU 1", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BASELINE BASELINE 1", "definition": "1 1 1999-06-19T08:45 1 9 (cont)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BASELINE BASELINE 2", "definition": "2 1 1999-06-19T09:00 1 10 (cont)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 160", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char DA", "definition": "Identifier Two-character abbreviation for the domain most relevant to the observation.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DACAT", "definition": "Category of Assessment Char *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DA Example 1", "definition": "Example 1 below shows drug accounting for a study with two study meds and one rescue med, all of which are measured in tablets. The sponsor has chosen to add EPOCH from the list of timing variables and to use DASPID and DAREFID for code numbers that appear on the label.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DISPAMT", "definition": "Amount Dispensed Rescue Medication 6", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TABLETS", "definition": "Study Med Period 1 2004-07-15", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DA Example 2", "definition": "Example 2 is for a study where drug containers, rather than their contents, are being accounted for and the sponsor did not track returns. In this case, the purpose of the accountability tracking is to verify that the containers dispensed were consistent with the randomization. The sponsor has chosen to use DASPID to record the identifying number of the container dispensed or returned.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 162", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char MB", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MBSPID", "definition": "Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Organism identifier. For organism identification, MBSPID would remain the same each time the same organism is identified in a new specimen.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 164", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MBTPT", "definition": "Planned Time Point Name Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "The use of GRPID to relate MS to MB greatly simplifies RELREC because only two records are needed in RELREC to describe the relationship of", "definition": "MB to the many related records in MS. With this method there is no need to create detailed relationships at the subject level. Other standard methods of relating records can also be used, but will produce a more complicated RELREC requiring detail of the relationships by subject. For example, if MBSEQ and MSSEQ are used, then RELREC would contain records for each specimen's MBSEQ, and all of the related MS findings by MSSEQ, for every subject.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 166", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char MS", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MSSPID", "definition": "Sponsor Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 168", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MSTPT", "definition": "Planned Time Point Name Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 170", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 6", "definition": "Shows no organisms have grown from this specimen at Visit 3. Therefore the organism recorded is \"NO GROWTH\".", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row 1-6", "definition": "Show MBMETHOD being used for reporting the method of testing the sample, e.g. GRAM STAIN or CULTURE PLATE. Microbiology Example 1 MB dataset", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "GRAM STAIN", "definition": "1 2005-06-19T08:00 2 (cont) 2+ FEW", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CULTURE PLATE", "definition": "3 2005-07-06T08:00 If the method of the collection of the sputum is reported (e.g., EXPECTORATION or BIOPSY), this information would go into SUPPMB. suppmb.xpt", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QUADRANT", "definition": ">=30 COLONIES IN 2ND QUADRANT 1 5 (cont) 0.125 mcg/mL 0.125 0.125 mcg/mL", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "E-TEST", "definition": "Example 5: RELREC to relate MB and MS Row 1, 2 - Show the one-to-many relationship between MB and MS. For any organism found in a microbiology specimen and recorded in MB, there may be multiple findings about that organism recorded in MS. The organism in MB can be linked to its findings in MS because MBGRPID=MSGRPID for any organism within a subject.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 172", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MSMETHOD", "definition": "1 (cont) 0.25 mcg/mL 0.25 mcg/mL", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BROTH DILUTION", "definition": "4 (cont) 0.5 mcg/mL 0.5 mcg/mL", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ZONE SIZE", "definition": "7 (cont) 0.25 mcg/mL 0.25 mcg/mL", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 174", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PC", "definition": "Identifier Two-character abbreviation for the domain most relevant to the observation.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 176", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 178", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "All Rows", "definition": "PCTPTREF is a text value of the description of a \u201czero\u201d time. It should be meaningful. If there are multiple PK profiles being generated, the zero time for each will be different (e.g., a different dose such as \"first dose\", \"second dose\"). In this example it is required to make values of PCTPTNUM and PCTPT unique (See Section 4.1.4.10). Rows 1-4, 12: Sponsor has standardized values of \u201c<0.01\u201d to \u201c0\u201d for this study. Rows 5, 6, 19, 20, 25, 26, 29, and 30: Specimen properties (volume and pH) are submitted as separate rows. Rows 3-6, 17-20, 23-30: The elapsed times for urine samples are based upon the elapsed time (from the reference time point, PCTPTREF) for the end of the specimen collection period. Elapsed time values that are the same for urine and plasma samples have been assigned the same value for PCTPT. For the urine samples, the value in PCEVLINT describes the planned evaluation (or collection) interval relative to the time point. The actual evaluation interval can be determined by determining PCENDTC - PCDTC. Row STUDYID DOMAIN USUBJID PCSEQ PCGRPID PCREFID PCTESTCD", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PCCAT", "definition": "PCSPEC PCORRES PCORRESU PCSTRESCPCSTRESNPCSTRESU 1", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANALYTE PLASMA", "definition": ") CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "URINE", "definition": "2.4 ng/mL 2.4 2.4 ng/mL 29", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DAY 11", "definition": "11 2001-02-11T14:03 2001-02-11T20:10 11 12H 3 Day 11 Dose 2001-02-11T08:00", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PREDOSE", "definition": "0 Day 11 Dose 2001-02-11T08:00 -PT15M 15 (cont) 0.10 3", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PT6H", "definition": "-PT6H 21 (cont) 0.10 3", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DAY 2", "definition": "2 2001-02-02T08:00 2 24H 3 Day 1 Dose 2001-02-01T08:00", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PT12H", "definition": "-PT6H 27 (cont) 2.00 4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DAY 12", "definition": "12 2001-02-12T08:00 12 24H 4 Day 11 Dose 2001-02-11T08:00", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PT24H", "definition": "-P12H 31 (cont) 0.10 4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 180", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DRUG A PARENT", "definition": "Half-life of 2nd exp phase 4.50", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DRUG A METABOLITE", "definition": "THALF_2 Half-life of 2nd exp phase 2.25", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clearance", "definition": "0.88 L/h (Additional variables in dataset example on following page- > ) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DAY 8", "definition": "2 2001-02-08T18:30 8 600 min 12", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 182", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RELATING DATASETS", "definition": "If all time-point concentrations in PC are used to calculate all parameters for all subjects, then the relationship between the two datasets can documented as shown in the table below. Note that incorporating the name of the analyte and the day of the collection into the value of --GRPID (or some equivalent method for assigning different values of --GRPID for all the combinations of analytes and reference time points) is necessary when there is more than one reference time point (PCRFTDTC and PPRFTDTC, which are the same for related records), and more than one analyte (PCTESTCD, copied into PPCAT to indicate the analyte with which the parameters are associated), since these variables are part of the natural key (see Section 3.2.1.1) for both datasets. In this case, --GRPID is a surrogate key (Section 3.2.1.1) used for the relationship.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RELATING RECORDS", "definition": "Four possible examples of different types of relationships between PC and PP records for one drug (DRUG X in this case) are described. For all of these, the actual PC and PP data are the same. The only variables whose values change across the examples are the sponsor-defined PCGRPID and PPGRPID. As in the case for relating datasets above (Section 6.3.10.5.1), --GRPID values must take into account all the combinations of analytes and reference time points, since both are part of the natural key (see Section 3.2.1.1) for both datasets. To conserve space, the PC and PP domains appear only once, but with four --GRPID columns, one for each of the examples. Note that a submission dataset would contain only one --GRPID column with a set of values such as those shown in one of the four columns in the PC and PP datasets, or values defined by the sponsor. The example specifics are as follows: Example 1: All PK time-point-concentration values in the PC dataset are used to calculate all the PK parameters in the PP dataset for both Days 1 and 8 for one subject. Pharmacokinetic Concentrations (PC) Dataset For All Examples Pharmacokinetic Parameters (PP) Dataset For All Examples RELREC Example 1. All PC records used to calculate all PK parameters \u2022 Method A (Many to many, using PCGRPID and PPGRPID) \u2022 Method B (One to many, using PCSEQ and PPGRPID) \u2022 Method C (Many to one, using PCGRPID and PPSEQ) \u2022 Method D (One to one, using PCSEQ and PPSEQ) Example 2: Two PC values were excluded from the calculation of all PK parameters for the Day 1 data. Day 8 values are related as per Example 1. RELREC Example 2: Only some records in PC used to calculate all PK parameters \u2022 Method A (Many to many, using PCGRPID and PPGRPID) \u2022 Method B (One to many, using PCSEQ and PPGRPID) \u2022 Method C (Many to one, using PCGRPID and PPSEQ) \u2022 Method D (One to one, using PCSEQ and PPSEQ) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 184", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABC-123-0001", "definition": "12 DY1_DRGX DY1_DRGX DY1_DRGX_A DY1DRGX_D 123-0001-12", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DRUG X", "definition": "First dose of study drug, where drug is DRUG X 2 weeks after start of Element", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PCELTM", "definition": "1 (cont) 9 9 ug/mL 1.00 1", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Day 1 Dose", "definition": "2001-02-01T08:30 PT10H 13 (cont) 10.0 10.0 ug/mL 1.00 2", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Day 8 Dose", "definition": "2001-02-08T08:30 PT8H20M 24 (cont) 11.0 11.0 ug/mL 1.00 2", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 186", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "5 (cont)", "definition": "T1/2, 2 Half-life of 2nd exp phase", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "12 (cont)", "definition": "T1/2, 2 Half-life of 2nd exp phase", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DY8DRGX", "definition": "2 * RELID 1 indicates records with PCSEQ values of 1-12 are related to records with PPGRPID = DY1DRGX. * RELID 2 indicates records with PCSEQ values of 13-24 are related to records with PPGRPID = DY8DRGX. Method C (Many to one, using PCGRPID and PPSEQ)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PPSEQ", "definition": "7 4 The Day 8 relationships are the same as those shown in Example 1. * RELID 1 indicates records with PCSEQ values of 1-4 and 6-12 are related to the record with a PPSEQ value of 1. * RELID 2 indicates records with PCSEQ values of 1-5 and 7-12 are related to the record with a PPSEQ value of 2. * RELID 3 indicates records with PCSEQ values of 1-10 are related to the record with a PPSEQ value of 3. * RELID 4 indicates records with PCSEQ values of 1-12 are related to the records with PPSEQ values of 4-7.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 188", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DY1DRGX", "definition": "1 The Day 8 relationships are the same as those shown in Example 1. * RELID 1 indicates records with PCSEQ values of 1-7 and 10-12 are related to records with PPGRPID = DY1DRGX. * RELID 2 indicates records with PCSEQ values of 13-24 are related to records with PPGRPID = DY8DRGX. Method C (Many to one, using PCGRPID and PPSEQ)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 190", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PPGRPID", "definition": "DY1DRGX_HALF 2 The Day 8 relationships are the same as those shown in Example 1. * RELID 1 indicates records with PCSEQ values of 1-12 are related to records with PPGRPID = DY1DRGX_A * RELID 2 indicates records with PCSEQ values of 1-7 and 10-12 are related to records with PPGRPID = DY1DRGX_HALF. Method C (Many to one, using PCGRPID and PPSEQ)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 192", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PCGRPID", "definition": "DY1DRGX_D 4 The Day 8 relationships are the same as those shown in Example 1. * Same RELID of \"1\" Indicates that Tmax used records with PCGRPID values DY1DRGX_A, DY1DRGX_C, and DY1DRGX_D. * Same RELID of \"2\" Indicates that Cmax used records with PCGRPID values DY1DRGX_A, DY1DRGX_B, and DY1DRGX_D. * Same RELID of \"3\" Indicates that AUC used PCGRPID values DY1DRGX_A, DY1DRGX_B, and DY1DRGX_C. * Same RELID of \"4\" Indicates that all other parameters (PPGRPID = OTHER) used all PC time points: PCGRPID values DY1DRGX_A, DY1DRGX_B, DY1DRGX_C, and DY1DRGX_D. Note that in the above RELREC table, the single records in rows 1, 3, 5, 7, and 9, represented by their --GRPIDs (TMAX, DY1DRGX_C, CMAX, DY1DRGX_B, AUC) could have been referenced by their SEQ values, since both identify the records sufficiently. At least two other hybrid approaches would have been acceptable as well: using PPSEQ and PCGRPIDs whenever possible, and using PPGRPID and PCSEQ values whenever possible. Method D below uses only SEQ values. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 194", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 196", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CFOBJ", "definition": "CFORRES CFORRESU CFSTRESC CFSTRESCU VISIT", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LEFT ARM", "definition": "Perm SDTMIG 2.4.3, SDTMIG 4.1.1.9", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 198", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VESICLES", "definition": ". 5. Records in CF may or may not relate to records in an Events domain, such as AE or CE. If there are related event records, then RELREC may be used to document the relationships. a. If the clinical event or condition being evaluated does not represent a reportable adverse event, and if no data about the event as a whole (e.g., start date, end date) is collected, then there is no requirement that there be an event record for the clinical event or condition. b. If the clinical event or condition being assessed represents a reportable adverse event, as defined/agreed in the particular study, then it must be recorded in the AE domain, since all adverse events must be recorded in the AE domain. 6. Although no examples for clinical findings related to interventions have been provided, data on findings about interventions are expected to arise and may be stored in CF. 7. The following qualifiers should generally not be used in CF: --BODSYS, --MODIFY, --DTHREL, --SEV. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Date of Collection", "definition": "Did you have the following?", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 200", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SYMPTOMS", "definition": "INVESTIGATOR GERD SYMPTOM MEASUREMENT (IF SYMPTOM OCCURRED) OCCURRED? Yes/No VOLUME (mL) Total for all episodes", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NAUSEA", "definition": "1 1 1 2006-02-02 10", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "XYZ-701-002", "definition": "13 NUMEPISD Number of episodes DIARRHEA 1 1 2 2006-02-03 14", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NOT DONE 2006-02-03", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VOMIT", "definition": ">10 >10 1 2006-02-02 4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 202", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit", "definition": "1 2 3 4 5 6", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AE Domain (For clarity, only selected variables are shown.)", "definition": "Row 1 shows the record for a verbatim term of \"Morning queasiness\", for which the maximum severity over the course of the event was \"Moderate.\" Row 2 shows ????", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CF domain", "definition": "Rows 1-4 show severity data collected at the four visits that occurred between the start and end of the AE 'Morning queasiness'. CFOBJ = NAUSEA, which is the value of AEDECOD in the associated AE record. Rows 5-6 show severity data collected at the two visits that occurred between the start and end of the AE 'Watery stools'. CFOBJ = DIARRHOEA, which is the value of AEDECOD in the associated AE record.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 204", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 206", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Domain", "definition": "A collection of observations with a topic-specific commonality about a subject", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rule", "definition": "Rule that expresses the criterion in computer-executable form.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 208", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Randomization", "definition": "Evaluation for disease progression Evaluation/consent for surgery", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "In the next diagram, the Epochs of the trial have been identified. The Epochs are represented by the rectangles", "definition": "\"behind\" the blocks representing the Elements. In this simple trial, which has three Elements in each Arm, there are three Epochs. There is not always a one-to-one relationship between the Elements in the Arms of the trial and the Epochs of the trial, but such a relationship is common, particularly for blinded trials.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 210", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Blind", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Drug B", "definition": "First dose of study drug, where drug is Drug B 2 weeks after start of Element", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 212", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P-5-10", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 214", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Placebo-5mg-10mg", "definition": "Second Treatment Epoch 4 5 5 mg 5", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Third Treatment Epoch", "definition": "6 10 10 mg 14", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "First Treatment Epoch", "definition": "2 5 5 mg 17", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TA", "definition": "CRS/No P/S CRS/No P/S Contin/", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 216", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rescue", "definition": "See Section 7.2.3.1 for additional discussion of when a decision point in a trial design should be considered to give rise to a new Arm. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screen Study Drug", "definition": "Blind/Rescue Blind/Open A Study Drug Open Drug A", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 218", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Treatment A", "definition": "5 days after start of", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Treatment B", "definition": "Assigned to Rescue on basis of", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 220", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "In the diagram below, the trial is considered to have one Epoch for each cycle, with each Epoch consisting of two", "definition": "Elements, a treatment Element and a rest Element. The choice between these alternatives is a somewhat subjective one. In oncology trials, there is a strong tradition of discussing \"cycles\" and the second diagram is more consistent with this tradition. However, if there were important analyses which distinguished between assessments or events in the Treatment and Rest Elements, then the first assignment of Epochs might better support those analyses.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 222", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "The logistics of dosing mean that few oncology trials are blinded, but the diagrams we have drawn might represent a", "definition": "blinded trial. If this trial is blinded, then the diagram below, based on the one-Epoch-per-cycle alternative, shows the trial from the viewpoint of blinded participants.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 224", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rest", "definition": "Last dose of previous treatment cycle + 24 hrs At least 16 days after start of Element and WBC recovered 5", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 226", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "R A Follow", "definition": "Trt A = Treatment A R A = Rest A B = Treatment B", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 228", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "The Trial Design Matrix below corresponds to the last diagram for this trial, with one Epoch per cycle.", "definition": "Trial Design Matrix for Example Trial 5, with one Epoch per Cycle", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rest A", "definition": "If disease progression, go to Follow-up Epoch 8", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rest B", "definition": "If disease progression, go to Follow-up Epoch 18", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 230", "definition": "CDISC. \u00a9 2007. All rights reserved July 1025, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "The Trial Design Matrix for this trial assumes that Epochs are assigned as in the diagram above. Note that in this", "definition": "trial, there are eight Elements in the treatment Epoch for Arm A, and six Elements in the treatment Epoch for Arm B. Trial Design Matrix for Example Trial 6", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 232", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 234", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "No surgery", "definition": "However, it is also possible to see this study as a two-Arm trial, but with major \"skip forward\" arrows for some subjects, as illustrated in the following diagram. 3-5w", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Arm 2", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Progression", "definition": "Example Trial 7, RTOG 93-09: Five Arms and Four Epochs", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 236", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Induction", "definition": "Chemo + RT 3-5 w", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 238", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CBST", "definition": "Addl Chemo + Rad Boost 4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Induction CR", "definition": "No Progression and eligible and consented to surgery 10", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FU", "definition": "Off Treatment Follow-up CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "up", "definition": "The Trial Arms dataset for the trial is also simpler for the two-Arm version of the trial. Note that this version has rules in the TRANS column that appeared in the BRANCH column in the five-Arm version of the Trial Arms dataset. In the five-Arm view of the trial, these decision points are considered to be branches between Arms, while in the two-Arm view of the trial, these are considered to represent variations within an Arm. Trial Arms dataset for Example Trial 7, as a tow-Arm trial", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 240", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DEFINING EPOCHS", "definition": "The series of examples in Section 7.2.2 provides a variety of scenarios and guidance about how to assign Epoch in those scenarios. In general, assigning Epochs for blinded trials is easier than for unblinded trials. The blinded view of the trial will generally make the possible choices clear. For unblinded trials, the comparisons that will be made between Arms can guide the definition of Epochs. For trials that include many variant paths within an Arm, comparisons of Arms will mean that subjects on a variety of paths will be included in the comparison, and this is likely to lead to definition of broader Epochs. 7.2.3.4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RULE VARIABLES", "definition": "The Branch and Transition columns shown in the example tables are variables with a Role of 'Rule.' The values of a Rule variable describe conditions under which something is planned to happen. At the moment, values of Rule variables are text. At some point in the future, it is expected that these will become executable code. Other Rule variables are present in the Trial Elements and Trial Visits datasets. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 242", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TAETORD", "definition": "Orders the Elements within an Arm ETCD, ELEMENT Name an Element within the Arm", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TABRANCH", "definition": "Indicate a branch in the trial design at the end of the Element. A branch may be a randomization or another method of assigning subjects to Arms", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TATRANS", "definition": "Indicates how to decide where a subject should go at the end of the Element. The default rule is, 'go to the next Element in sequence.'", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Epoch", "definition": "1 hour after start of Treatment", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TE", "definition": "10 10 mg First dose of a treatment Epoch, where dose is 10 mg drug 2 weeks after start of Element", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TEENRL", "definition": "Rule for End of Element Char", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 244", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Informed Consent", "definition": "Screening assessments are complete, up to 2 weeks after start", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Eligibility confirmed", "definition": "2 weeks after start of Element", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Placebo", "definition": "1 2 3 4 5 CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P14D", "definition": "Trial Elements Dataset for Example Trial 2", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P21D", "definition": "The Trial Elements dataset for Example Trial 4 illustrates Element end rules for Elements that are not of fixed duration. The Screen Element in this study can be up to 2 weeks long, but may end earlier, so is not of fixed duration. The Rest Element has a variable length, depending on how quickly WBC recovers. Note that the start rules for the A and B Elements have been written to be suitable for a blinded study. Trial Elements Dataset for Example Trial 4", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trt A", "definition": "First dose of treatment in Element, where drug is", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trt B", "definition": "First dose of treatment Element, where drug is Treatment B 5 days after start of Element", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P28D", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 246", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Step Question", "definition": "How step question is answered by information in the Trial Design datasets 1 Should the subject leave the current Element? Criteria for ending the current Element are in TEENRL in the TE dataset. 2 Which Element should the subject enter next? \u2022 If there is a branch point at this point in the trial, evaluate criteria described in TABRANCH (e.g., randomization results) in the TA dataset \u2022 otherwise, if TATRANS in the TA dataset is populated in this Arm at this point, follow those instructions \u2022 otherwise, move to the next Element in this Arm as specified by TAETORD in the TA dataset. 3 What does the subject do to enter the next Element? The action or event that marks the start of the next Element is specified in TESTRL in the TE dataset Note that the subject is not \"in limbo\" during this process. The subject remains in the current Element until Step 3, at which point the subject transitions to the new Element. There are no gaps between Elements. From this table, it is clear that executing a transition depends on information that is split between the Trial Elements and the Trial Arms datasets. It can be useful, in the process of working out the Trial Design datasets, to create a dataset that supplements the Trial Arms dataset with the TESTRL, TEENRL, and TEDUR variables, so that full information on the transitions is easily accessible. However, such a working dataset is not an SDTM dataset, and should not be submitted. The following table shows a fragment of such a table for Example Trial 4. Note that for all records that contain a particular Element, all the TE variable values are exactly the same. Also, note that when both TABRANCH and TATRANS are blank, the implicit decision in Step 2 is that the subject moves to the next Element in sequence for the Arm.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screening assessments", "definition": "are complete, up to 2", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Last dose of previous", "definition": "treatment cycle + 24 hrs 16 days after start of", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "P5D", "definition": "Note that both the first and fourth rows of this dataset involve the same Element, Trt A, and so TESTRL is the same for both. The activity that marks a subject's entry into the fourth Element in Arm A is \"First dose of treatment Element, where drug is Treatment A.\" This is not the subject's very first dose of Treatment A, but it is their first dose in this Element, which is in the Second Treatment Epoch. 7.3.4 RECAP OF TRIAL ELEMENTS VARIABLES", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TESTRL", "definition": "Describe the \"transition event\" that defines the start of the Element TEENRL, TEDUR Describe when the Element should end (TEDUR is used only if the Element is of fixed duration) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 248", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TV", "definition": "5 2 weeks after start of Treatment", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Start of Screen Epoch", "definition": "1 hour after start of Visit 2", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "At Trial Exit", "definition": "Although the start and end rules in this example reference the starts and ends of Epochs, the start and end rules of some Visits for trials with Epochs that span multiple Elements will need to reference Elements rather than Epochs. When an Arm includes repetitions of the same Element, it may be necessary to use TAETORD as well as an Element name to specify when a Visit is to occur. 7.4.3 TRIAL VISITS ISSUES 7.4.3.1 IDENTIFYING TRIAL VISITS In general, a trial's Visits are defined in its protocol. The term 'Visit' reflects the fact that data in out-patient studies is usually collected during a physical Visit by the subject to a clinic. Sometimes a Trial Visit defined by the protocol may not correspond to a physical Visit. It may span multiple physical Visits, as when screening data may be collected over several clinic Visits but recorded under one Visit name (VISIT) and number (VISITNUM). A Trial Visit may also represent only a portion of an extended physical Visit, as when a trial of in-patients collects data under multiple Trial Visits for a single hospital admission. Diary data and other data collected outside a clinic may not fit the usual concept of a Trial Visit, but the planned times of collection of such data may be described as 'Visits' in the Trial Visits dataset if desired. 7.4.3.2", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TRIAL VISIT RULES", "definition": "Visit start rules are different from Element start rules because they usually describe when a Visit should occur, while Element start rules describe the moment at which an Element is considered to start. There are usually gaps between Visits, periods of time that do not belong to any Visit, so it is usually not necessary to identify the moment when one Visit stops and another starts. However, some trials of hospitalized subjects may divide time into Visits in a manner more like that used for Elements, and a transition event may need to be defined in such cases. Visit start rules are usually expressed relative to the start or end of an Element or Epoch, e.g., '1-2 hours before end of First Wash-out' or '8 weeks after end of 2nd Treatment Epoch.' Note that the Visit may or may not occur during", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 250", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CONTINGENT VISITS", "definition": "Section 5.3.1, which describes the Subject Visits dataset, describes how records for unplanned Visits are incorporated. It is sometimes difficult to decide exactly what constitutes an \"unplanned Visit\" versus a \"contingent Visit, \" a Visit that is contingent on a \"trigger\" event, i.e., a Visit that the protocol says should take place under certain circumstances. Also, for certain contingent assessments, it can be difficult to decide whether performing that assessment constitutes a Visit. Contingent Visits can be included in the Trial Visits table, with start rules that describe the circumstances under which they will take place. Since values of VISITNUM must be assigned to all records in the Trial Visits dataset, a contingent Visit must be assigned a value of VISITNUM, but that value may not be a \"chronological\" value, due to the uncertain timing of the Visit. 7.4.4 RECAP OF TRIAL VISITS VARIABLES", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Identifiers", "definition": "VISIT, VISITNUM, VISITDY Name and order the Visits ARM, ARMCD Blank if Visit schedule does not depend on Arm. Name of the ARM if Visit schedule does depend on Arm.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TVSTRL", "definition": "Rule describing when the Visit should start. Usually expressed relative to the start or end of an Epoch or Element.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TVENRL", "definition": "Rule describing when the Visit should end. Usually expressed relative to the start of an Epoch or Element. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 252", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Char TS", "definition": "Identifier Two-character abbreviation for the domain.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "OBJPRIM", "definition": "Trial Primary Objective TO INVESTIGATE THE SAFETY AND EFFICACY OF TWO DOSES 14", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Title", "definition": "No controlled terminology. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TRT", "definition": "Reported Name Of Test Product Investigational New Drug 15", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 254", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and Safety of New", "definition": "Drug (up to 16 mg/day) in the", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAFETY", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ADDON", "definition": "Test Product Is Added On To", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DOSE", "definition": "Dose Per Administration 200 9", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "OBJSEC", "definition": "Trial Secondary Objective COMPARE SAFETY PROFILES", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PLANSUB", "definition": "Planned Number Of Subjects 210 16", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 256", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 258", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "THE --GRPID VARIABLE", "definition": "The optional grouping identifier variable --GRPID is permissible in all domains that are based on the general observation classes. It is used to identify relationships between records within a USUBJID within a single domain. An example would be Intervention records for a combination therapy where the treatments in the combination varies from subject to subject. In such a case, the relationship is defined by assigning the same unique character value to the --GRPID variable. The values used for --GRPID can be any values the sponsor chooses; however, if the sponsor uses values with some embedded meaning (rather than arbitrary numbers), those values should be consistent across the submission to avoid confusion. It is important to note that --GRPID has no inherent meaning across subjects or across domains. Using --GRPID in the general-observation-class datasets can reduce the number of records in the RELREC, SUPP--, and CO datasets when those datasets are submitted to describe relationships/associations for records or values to a \u2018group\u2019 of general-observation-class records. 8.1.1 --GRPID EXAMPLE The following table illustrates how to use --GRPID in the Concomitant Medications (CM) domain to identify a combination therapy. In this example, both subjects 1234 and 5678 have reported two combination therapies, each consisting of three separate medications. Each component of a combination is given the same value for CMGRPID. Note that for USUBJID 1234, the medications for CMGRPID = \u2018COMBO THPY 1\u2019 (Rows 1-3) are different from the medications for CMGRPID = \u2018COMBO THPY 2 (Rows 4-6). Likewise, for USUBJID 5678, the medications for CMGRPID = \u2018COMBO THPY 1\u2019 (Rows 7-9) are different from the medications for CMGRPID = \u2018COMBO THPY 2\u2019 (Rows 10-12). Additionally, the medications for Subject 1234 CMGRPID = \u2018COMBO THPY 1\u2019 and CMGRPID = \u2018COMBO THPY 2\u2019 (Rows 1-6) are different from the medications for Subject 5678 CMGRPID = \u2018COMBO THPY 1\u2019 and CMGRPID = \u2018COMBO THPY 2\u2019 (Rows 7-12). This example illustrates how CMGRPID groups information only within a subject within a domain. Row STUDYID DOMAIN USUBJID CMSEQ CMGRPID", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "mg", "definition": "2004-03-21 2004-03-22 CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 260", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study Identifier Char", "definition": "Unique identifier for a study", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "In the sponsor's operational database, these datasets may have existed as either separate datasets that were merged", "definition": "for analysis, or one dataset that may have included observations from more than one general observation class (e.g., Events and Findings). The value in IDVAR must be the name of the key used to merge/join the two datasets. In the above example, the --SPID variable is used as the key to identify the related observations. The values for the --SPID variable in the two datasets are sponsor defined. Although other variables may also serve as a single merge key when the corresponding values for IDVAR are equal, --SPID or --REFID are typically used for this purpose. The variable RELTYPE identifies the type of relationship between the datasets. The allowable values are ONE and MANY. This information defines how a merge/join would be written, and what would be the result of the merge/join. The possible combinations are: 1. ONE and ONE. This combination indicates that there is NO hierarchical relationship between the datasets and the records in the datasets. Only One record from each dataset will potentially have the same value of the IDVAR within USUBJID. 2. ONE and MANY. This combination indicates that there IS a hierarchical (parent/child) relationship between the datasets. One record within USUBJID in the dataset identified by RELTYPE=ONE will potentially have the same value of the IDVAR with many (one or more) records in the dataset identified by RELTYPE=MANY. 3. MANY and MANY. This combination is unusual and challenging to manage in a merge/join, and may represent a relationship that was never intended to convey a usable merge/join (such as in described for PC and PP in Section 6.3.10.5). Since IDVAR identifies the keys that can be used to merge/join records between the datasets, the root values (i.e., SPID in the above example) for IDVAR must be the same for both records with the same RELID. --SEQ cannot be used because --SEQ only has meaning within a subject within a dataset, not across datasets.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 262", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 264", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Abbreviation", "definition": "Char * Domain Abbreviation of the Parent record(s).", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Variable", "definition": "Char * Identifying variable in the dataset that identifies the related record(s). Examples: --SEQ, --GRPID.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Variable Name", "definition": "Char * The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., '1TEST'). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor\u2019s operational dataset.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Evaluator", "definition": "Char * Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include ADJUDICATION COMMITTEE, STATISTICIAN, DATABASE ADMINISTRATOR, CLINICAL COORDINATOR, etc.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SPUNFL", "definition": "Any Time in Spec. Unit?", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RLCNDF", "definition": "Visit Related to Study Med Cond.?", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUPPQUAL Variables", "definition": "HO Events General Observation Class Custom Dataset with SUPPHO Supplemental Qualifiers dataset: The shading in the two datasets below is used to differentiate the three hospitalization records for which data are shown. Note that for Rows 1-7 in the SUPPHO dataset, RDOMAIN= HO, USUBJID = 0001, IDVAR = HOSEQ, and IDVARVAL = 1. These three values (along with STUDYID and USUBJID) allow these seven SUPPHO records to be linked to the HO dataset record in Row 1 which has value in HOSEQ = 1 for Subject 0001. Likewise, SUPPHO dataset rows 8-14 are linked to the HO dataset record where HOSEQ = 2 for the same subject, and SUPPHO dataset rows 15-21 are linked to the HO dataset record where HOSEQ =1 for Subject 0002. ho.xpt: Hospitalization (modeled as a custom Events general-observation-class domain) Row STUDYID DOMAIN USUBJID HOSEQ", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HO", "definition": "0002 1 Hospitalization 2004-01-21 2004-01-22 P1D", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 266", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HOSEQ", "definition": "1 RLCNDF Visit Related to Study Med Cond.?", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Comments Examples", "definition": "The table below shows the following: \u2022 A comment unrelated to any specific domain or record, because it was collected on a separate comments page/screen (Row 1) \u2022 A comment related to a specific domain (PE in this example), but not to any specific record because it was collected on the bottom of the PE page without any indication of specific records it applies to. COREF is populated with the text \u2018VISIT 7\u2019 to show this comment came from the VISIT 7 PE page (Row 2) \u2022 Comments related to parent records:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "A comment related to multiple VS records with VSGRPID=\u2019VS2\u2019", "definition": "\u2022 Three options are available for representing a comment unrelated to any specific general observation class record(s) because it was collected on a separate comments page/screen, but the page was associated with a specific visit:", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 268", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "A comment related to a Subject Visit record in SV (Row 6). The RDOMAIN variable is populated", "definition": "with SV (the Subject Visits domain) and the variables IDVAR and IDVARVAL are populated with the key variable name and value of the parent Subject-Visit record.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "COREF is populated to indicate that the comment reference is \u201cVISIT 4\u201d. RDOMAIN, IDVAR,", "definition": "and IDVARVAL are not populated.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VISIT 4", "definition": "PRINCIPAL INVESTIGATOR PRINCIPAL INVESTIGATOR 4 8.6 RELATING FINDINGS OBSERVATIONS TO EVENTS OR INTERVENTIONS USING --OBJ The Clinical Findings domain introduces the --OBJ variable. A record in CF may have a parent record in an event or intervention domain, although a parent record in another domain is not required. When there is a parent-child relationship between an event or intervention record and a CF record, --OBJ establishes that relationship. See the following for further information: \u2022 Section 2.4.3 for a definition of the --OBJ variable \u2022 Section 6.3.11 for the Clinical Findings domain definition and examples illustrating the use of the --OBJ variable. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 270", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FINDINGS ABOUT EVENTS", "definition": "This section discusses events, findings, and findings about events. The relationship between interventions, findings, and findings about interventions is similar. The names of the new Clinical Events (Section 6.2.5) and Clinical Findings (Section 6.3.11) domains are similar because both are intended to hold data about \"clinical\" events or conditions. The Clinical Findings domain was specially created to store findings about events. This section discusses events and findings generally, but it is particularly useful for understanding the distinction between the CE and CF domains. There may be several sources of confusion about whether a particular piece of data belongs in an event record or a findings record. One generally thinks of an event as something that happens spontaneously, and has a beginning and end; however, one should consider the following: \u2022 Events of interest in a particular trial may be pre-specified, rather than collected as free text. \u2022 Some events may be so long lasting in that they are perceived as \"conditions\" rather than \"events\", and their beginning and end dates are not of interest. \u2022 Some variables or data items one generally expects to see in an Events record may not be present. For example, a post-marketing study might collect the occurrence of certain adverse events, but no dates. \u2022 Properties of an Event may be measured or assessed, and these are then treated as findings about events, rather than as events. \u2022 Some assessments of events (e.g., severity, relationship to study treatment) have been built into the SDTM Events model as qualifiers, rather than being treated as findings about events. \u2022 Sponsors may choose how they define an Event. For example, adverse event data may be submitted using one record that summarizes an event from beginning to end, or using one record for each change in severity. The structure of the data being considered, although not definitive, will often help determine whether the data represent an Event or a Finding. The structural questions below may assist sponsors in deciding where data should be placed in SDTM.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 272", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Appendices", "definition": "APPENDIX A: CDISC SDS TEAM *", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Company", "definition": "Fred Wood, Team Leader Octagon Research Solutions, Inc. Wayne Kubick, Past Team Leader", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FDA Observer", "definition": "* Individuals having met membership criteria as of publication date. CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ATC code", "definition": "Anatomic Therapeutic Chemical code from WHO Drug", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AUC", "definition": "Area under the curve (PK and PD)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "BID", "definition": "Twice a Day (Latin: bis in die)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDISC", "definition": "Clinical Data Interchange Standards Consortium", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMAX", "definition": "Concentration maximum; used in pharmacokinetics and bioequivalence testing to indicate maximum plasma concentration for a drug", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CTCAE", "definition": "Common Terminology Criteria for Adverse Events", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dataset", "definition": "A collection of structured data in a single file", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Health Level 7", "definition": "HPLC/MS High Performance Liquid Chromatography/Mass Spectrometer", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ICD9", "definition": "International Classification of Diseases, 9th revision. See also MedDRA.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ICH", "definition": "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ICH E2A", "definition": "ICH guidelines on Clinical Safety Data Management : Definitions and Standards for Expedited", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ICH E3", "definition": "ICH guidelines on Structure and Content of Clinical Study Reports", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ICH E9", "definition": "ICH guidelines on Statistical Principles for Clinical Trials", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ISO 3166", "definition": "ISO country codes. The SDTM uses the three-character format.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ISO 8601", "definition": "ISO character representation of dates, date/times, intervals, and durations of time", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LOINC", "definition": "Logical Observation, Identifiers, Names, and Codes", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MedDRA", "definition": "Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies (such as COSTART and ICD9) used in the medical product", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PD", "definition": "Pharmacodynamics. The effect of the drug on physiological measures in the subject.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PK", "definition": "Pharmacokinetics. The study of the absorption, distribution, metabolism and excretion of a drug.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QD", "definition": "Every Day (Latin: quaque die)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SDS", "definition": "Submission Data Standards. Also the name of the Team that created the SDTM and SDTMIG", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SDTMIG", "definition": "Submission Data Standards SDTM Implementation Guide for Human Clinical Trials (this document)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SEND", "definition": "Standard for Exchange of Non-Clinical Data", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SF-36", "definition": "A multi-purpose, short-form health survey with 36 questions", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SNOMED", "definition": "Systematized Nomenclature of Medicine (a dictionary)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOC", "definition": "CDISC System Organ Class --BODSYS Populated using a code value in the list of controlled terms, codelist SOC (C66783) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TID", "definition": "Three Times Daily (Latin: ter in die)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TMAX", "definition": "The time after dosing when Cmax occurs (PK) or when the maximum effect is observed (PD)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "UUID", "definition": "Universally Unique Identifier V3.x Version 3.1 of the SDSIG and all subsequent versions of the SDTMIG", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WHODRUG", "definition": "World Health Organization Drug Dictionary", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 274", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Treatment", "definition": "--CAN Populated using a code value in the list of controlled terms, codelist ACN (C66767) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Age Unit", "definition": "Populated using a code value from the list of controlled terms, codelist AGEU (C66781) at http://www.cdisc.org/standards/terminology/index.html Units are associated with", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AESEV", "definition": "Populated using a code value in the list of controlled terms, codelist AESEV (C66769) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ETHNIC", "definition": "Will be changed to Subject Ethnic Group in the future", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Form", "definition": "--DOSFRM Populated using a code value in the list of controlled terms, codelist FRM (C66726) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Size", "definition": "Controlled Terms for when VSTESTCD = FRMSIZE (Frame Size) Populated using a code value in the list of controlled terms, codelist SIZE (C66733) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "IECAT", "definition": "Populated using a code value in the list of controlled terms, codelist IECAT (C66797) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBTESTCD", "definition": "Populated using a code value in the list of controlled terms, codelist LBTESTCD (C65047) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBTEST", "definition": "Populated using a code value in the list of controlled terms, codelist LBTEST (C65154) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "See also LBTESTCD", "definition": "CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 276", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Non-Completion", "definition": "DSDECOD when DSCAT = \u201cDISPOSITION EVENT\u201d Populated using a code value in the list of controlled terms, codelist NCOMPLT (C66727) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "No Yes Response", "definition": "--PRESP, --OCCUR, --SCAN, --SCONG, --SDISAB, --SDTH, --SHOSP, --SLIFE, --SOD, --SMIE, --CONTRT, --BLFL, --FAST, --DRVFL, ADDON (Trial Summary Parameter) Populated using a code value in the list of controlled terms, codelist NY (C66742) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Outcome of Event", "definition": "--OUT Populated using a code value in the list of controlled terms, codelist OUT (C66768) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ROUTE", "definition": "Route of Administration --ROUTE Populated using a code value in the list of controlled terms, codelist ROUTE (C66728) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SEX", "definition": "Populated using a code value in the list of controlled terms, codelist SEX (C66731) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSTESTCD", "definition": "Populated using a code value in the list of controlled terms, codelist VSTESTCD (C66741) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VSTEST", "definition": "Populated using a code value in the list of controlled terms, codelist VSTEST (C67153) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "See also VSTESTCD", "definition": "CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Applicable", "definition": "Added as a \u201crestricted prefix\u201d and variable naming prefix - see Appendix D. Do not use as a Domain Code. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Events", "definition": "Evidence of disease or condition, including objective signs and subjective symptoms that are typically observed by a physician or described to the investigator by the subject.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Findings", "definition": "Semi-Quantitative measurement of vertebral fractures CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Purpose", "definition": "See SDTM 3.3. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 278", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Meal Data", "definition": "Interventions Information regarding the subject's meal consumption, such as fluid intake, amounts, form (solid or liquid state), frequency, etc., typically used for PK analysis. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "will not be used with", "definition": "SDTM standard domains, where - may be any valid letter or number. CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 280", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Autopsy", "definition": "TBD (To Be Determined) Additional data about deaths, specific to findings from autopsies.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Under Discussion", "definition": "Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Under Development", "definition": "Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 282", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Treatments", "definition": "Populated using a code value from the list of controlled terms, codelist No Yes Response (C66742) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DO NOT USE -", "definition": "Information on dictionaries and dictionary versions be", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "included in the SDTM", "definition": "metadata, since the define.xml specification has explicit mechanisms for handling references to dictionaries and dictionary versions. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "at", "definition": "http://www.cdisc.org/standards/terminology/index.html CDISC SDTM Implementation Guide (Version 3.1.2) APPENDIX C4: DRUG ACCOUNTABILITY TEST CODES The following table contains the test codes suggested by CDISC for use in DRUG Accountability domains.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of Subjects", "definition": "No controlled terminology. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Age Group", "definition": "Populated using a code value from the list of controlled terms, codelist AGESPAN (C66780) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "A record for each", "definition": "applicable category should be included. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AGEMAX", "definition": "Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Name", "definition": "No controlled terminology. In the future, may be added to list of controlled terms on CDISC website.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Administration", "definition": "(ROUTE) Includes many more controlled terms than for those listed in CDISC Notes for \u2013 ROUTE. Includes more specific routes than INHALATION listed in CDISC notes for SUROUTE on page 50.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "to submit dosing", "definition": "parameters, as the TE and TA datasets are better suited to describing such information. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Frequency", "definition": "Use controlled terminology for interventions (DOSFRQ). Dose frequency associated with a test product or comparative treatment. In the future, may be added to list of controlled terms on CDISC website", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dose Units", "definition": "Use controlled terminology for interventions (DOSU). Units used with value(s) in DOSE. In the future, may be added to list of controlled terms on CDISC website", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Indication", "definition": "No controlled terminology. In the future, may be added to list of controlled terms on CDISC website", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Length", "definition": "No controlled terminology. Defined as the planned", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "length of time for a", "definition": "subject's participation. It should be recorded using", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "the IS8601 format for", "definition": "durations, see Section 4.1.4.3. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 284", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Objective", "definition": "No controlled terminology Should be described in", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "terms of the desired", "definition": "statement in labeling. In the future, may be added to list of controlled terms on CDISC website", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subjects", "definition": "No controlled terminology. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Randomized", "definition": "Populated using a code value from the list of controlled terms, codelist NY (C66742) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Participants", "definition": "Populated using a code value from the list of controlled terms, codelist SEXPOP (C66732) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Organization", "definition": "No controlled terminology. In the future, may be added to list of controlled terms on CDISC website", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rules", "definition": "If the trial has study stop rules (STOPRULE is not equal to \"NONE\"), contains a description of the stop rules. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Schema", "definition": "Populated using a code value from the list of controlled terms, codelist TPLIND (C66735) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Control Type", "definition": "Populated using a code value from the list of controlled terms, codelist TCNTRL (C66785) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Group", "definition": "Populated using a code value from the list of controlled terms, codelist TDIGRP (C66787) at http://www.cdisc.org/standards/terminology/index.html If trial does not enroll healthy subjects (TDIGRP is not equal to \"HEALTHY SUBJECTS\"), contains the diagnosis of subjects to be enrolled. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Type", "definition": "Populated using a code value from the list of controlled terms, codelist TINDTP (C66736) at http://www.cdisc.org/standards/terminology/index.html", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TINDTP provides a", "definition": "classification system for the indication provided as text in INDIC.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "the adverse effect of", "definition": "another treatment. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Classification", "definition": "Populated using a code value from the list of controlled terms, codelist TPHASE (C66737) at http://www.cdisc.org/standards/terminology/index.html The controlled terminology for phase includes several formats as synonyms. Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of Test Product", "definition": "No controlled terminology. In the future, may be added to list of controlled terms on CDISC website", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Type", "definition": "Populated using a code value from the list of controlled terms, codelist TTYPE (C66739) at http://www.cdisc.org/standards/terminology/index.html Included as a value in the list of controlled terms, codelist Trial Summary Parameter Test Code (C66738)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Returned Amount", "definition": "APPENDIX C5: SUPPLEMENTAL QUALIFIERS NAME CODES The following table contains an initial set of standard name codes for use in the Supplemental Qualifiers (SUPP--) special-purpose datasets. There are no specific conventions for naming QNAM and some sponsors may choose to include the 2- character domain in the QNAM variable name. Note that the 2-character domain code is not required in QNAM since it is present in the variable RDOMAIN in the SUPP-- datasets.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dictionary Version", "definition": "AE, MH, PE and other domains that use dictionary-", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "High Level Group Term", "definition": "AE, MH, PE, and any other domain coded to MedDRA --HLT", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "High Level Term", "definition": "AE, MH, PE, and any other domain coded to MedDRA --LLT", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Lower Level Term", "definition": "AE, MH, PE, and any other domain coded to MedDRA", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ITT", "definition": "Intent to Treat Population Flag", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 286", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RL", "definition": "CDISC, \u00a9 2007. All rights reserved", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 288", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "General", "definition": "Changed abbreviation from SDSIG to SDTMIG . Updated references to SDTM v1.1. Introduced abbreviation of V3.x to refer to V3.1 IG and subsequent versions.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Change", "definition": "Controlled Terminology - Type of Trial (TTYPE) 1) TSPARMCD was changed from TYPE on page 170 to TTYPE. 2) TSVAL CONFIRMATORY and EXPLORATORY were removed based on review comments. 3) TSVAL PHARMACODYNAMICS changed to PHARMACODYNAMIC 4) TSVAL PHARMACOGENOMICS changed to PHARMACOGENOMIC TSVAL PHARMACOKINETICS changed to PHARMACOKINETIC", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Add", "definition": "10.3.1 Added SI Infection Site Measurements to domain codes.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Document", "definition": "New Pharmacokinetics Parameters domain model and example", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Correct", "definition": "10.4 Corrected list of fragments (Domain codes are no longer included in this fragment list, but appear only in 10.3.1). E4: CHANGES FROM CDISC SDTMIG V3.1.1 TO V3.1.2 DRAFT Note: This is limited to Appendix 10 changes as of current printing.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sections 5", "definition": "& 6 Changed the header for all domain models to use lowercase xpt filenames for consistency with eCTD specifications.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Section 6", "definition": "Changed domain models for CM, SU, AE, MH to address possible use of new SUPP-- variable --PRESP, reconsider use of --OCCUR, and emphasize importance of including data that represents actual interventions or events.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 290", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 292", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "move", "definition": "6.1.1.0 Added new assumption 5 to discuss record structure. Removed old assumption 5 (which was redundant with Notes and Section 4.1.4.7.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Replace", "definition": "9.5.1 Replaced Trial Design examples with new examples to better communicate core concepts; added new TS example.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Remove", "definition": "10.3.1 Removed reserved codes for DR, DY, NE, PF, RF, SZ, VX as these may no longer be necessary as separate domains. Changed code for Biopsy from BX to BR.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 294", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Delete", "definition": "10.3.2 Removed \u201cFINDING\u201d from list of controlled terms for EG.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Addition", "definition": "10.3.1 \u2013 Reserved Domain Codes \u2013 AD,", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FH", "definition": "Added Analysis Dataset and Family History", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Domain Codes - AU", "definition": "Class for Autopsy changed to TBD ( To Be Determined). SDS team has not yet determined the class or possibly classes for this domain. Findings obtained during an autopsy would fall into another domain such as organ measurements) or lab tests such as analysis of stomach contents. Facts about the autopsy may need to be captured such as date of autopsy, autopsy start and end dates, whether it is a complete or partial autopsy etc.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Codes", "definition": "Controlled terminology will be published on the CDISC website. CDISC SDTM Implementation Guide (Version 3.1.2)", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 296", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Changes", "definition": "Removed Controlled Terminology - Units for Vital Signs Results (VSRESU) Controlled terminology is published on the CDISC website. Examples were in CDISC notes for VSORRESU on page 126.More units were added and some were modified: 1) INCHES changed to IN 2) FEET is not included 3) POUNDS changed to LB BEATS PER MINUTE changed to BEATS/MINUTE Removed Section 10.3.3 Vital", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Signs Test Codes", "definition": "(VSTESTCD, VSTEST) Controlled terminology is published on the CDISC website and some changes made from10.3.3 Vital Signs Test Codes Page 167 1) VSTEST \u201cFrame Size\u201d changed to \u201cBody Frame Size\u201d 2) VSTEST \u201cBody Fat\u201d changed to \u201cAdipose Tissue\u201d", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study Treatment", "definition": "Examples were in CDISC notes for AEACN on page 54. DRUG INTERRUPTED was not included as an example.", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "for Non-Completion", "definition": "(NCOMPLT) Examples were in CDISC notes for DSDECOD disposition events on page 60. Added \u201cRECOVERY\u201d, Changed \u201cWITHDRAWAL OF CONSENT\u201d to \u201cWITHDRAWAL BY SUBJECT\u201d", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 298", "definition": "CDISC. \u00a9 2007. All rights reserved July 25, 2007", "sources": [ "SDTM.pdf" ], "source": "SDTM.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "T h i r d E d i t i o n", "definition": "S u s a n n e P r o k s c h a", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MANAGEMENT", "definition": "T h i r d E d i t i o n S u s a n n e P r o k s c h a CRC Press is an imprint of the Taylor & Francis Group, an informa business Boca Raton London New York", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRC Press", "definition": "Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 \u00a9 2012 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 2011916 International Standard Book Number-13: 978-1-4398-4831-9 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. 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Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Preface......................................................................................................................xv", "definition": "Introduction............................................................................................................xvii Section I Study Startup", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "The Data Management Plan..................................................................3", "definition": "History of Data Management Plans......................................................3 What Goes into a DMP?.......................................................................4 Signing Off on the DMP.......................................................................5 Revising the DMP.................................................................................5 DMPs and the Study Files....................................................................6 Using DMPs with CROs.......................................................................6 Quality Assurance and DMPs..............................................................7 SOPs for DMPs and Study Files...........................................................7 Using Data Management Plans.............................................................8", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRF Design Considerations..................................................................9", "definition": "Primary Goals of CRF Design.............................................................9 Collecting Required Data: Visits, Procedures, Fields....................10 Protocol Compliance......................................................................12 Collecting Analyzable Data...........................................................13 Secondary Goal: Reducing Queries.................................................... 14 Avoiding Duplicate Data................................................................ 14 Eliminating Missing or Ambiguous Responses.............................15 CRFs with Data Processing Impact.................................................... 16 Log Forms...................................................................................... 17 Questionnaires............................................................................... 18 Diagrams and Analog Scales.........................................................19 Early Termination Visits................................................................20 Revisions to the CRF..........................................................................20 Quality Assurance for CRFs...............................................................21 SOPs on CRF Design..........................................................................22 Reuse and Refine CRF Modules.........................................................22", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Database Design Considerations.........................................................23", "definition": "Making Design Decisions...................................................................23 Basic Clinical Database Concepts......................................................24 Field Data Types.............................................................................24", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Numeric Fields...............................................................................25", "definition": "Dates..........................................................................................26 Texts..........................................................................................28 Coded Data.....................................................................................28 Identifier Fields..............................................................................30 Calculated or Derived Values........................................................ 31 Tall-Skinny versus Short-Fat Tables...................................................32 Using Standards..................................................................................34 After Deciding on a Design................................................................35 Quality Assurance for Database Design.............................................35 SOPs for Database Design..................................................................35 Responsibilities in Database Design...................................................36", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Edit Checks.........................................................................................37", "definition": "Choosing Edit Checks.........................................................................37 Missing Values...............................................................................38 Simple Range Checks....................................................................38 Logical Inconsistencies..................................................................38 Cross-Form or Cross-Page Checks................................................39 Protocol Violations.............................................................................39 Specifying Edit Checks......................................................................40 Quality Assurance of Edit Checks......................................................40 SOPs for Edit Checks..........................................................................40 The Connection to Queries.................................................................42", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Preparing to Receive Data..................................................................43", "definition": "Overview of Creating Study Databases..............................................43 Validating Study Databases................................................................44 A Study Validation Plan.....................................................................45 Database Specifications......................................................................45 Paper Studies..................................................................................45 EDC Studies...................................................................................46 How Building Impacts Specifications............................................46 Testing Study Databases.....................................................................46 Testing Environment......................................................................47 Testing Paper Studies.....................................................................47 Testing EDC Studies......................................................................48 Final Steps in Testing.....................................................................48 Moving to Production.........................................................................48 Study Database Change Control.........................................................49 Quality Assurance for Building Studies............................................. 51 SOPs for Preparing for Data............................................................... 51 Study Creation Is Programming.........................................................52", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Receiving Data on Paper.....................................................................55", "definition": "Transcribing Data...............................................................................55 Double Entry..................................................................................55 OCR Plus Review...........................................................................56 Single Entry....................................................................................56 How Close a Match to the CRF?........................................................57 Dealing with Problem Data................................................................58 Illegible Fields................................................................................58 Notations in Margins.....................................................................58 Using Preentry Review..................................................................59 Changing Data after Entry..................................................................59 Quality Assurance and Quality Control for Entry..............................60 Audit Plan.......................................................................................60 Audit Process................................................................................. 61 Audit Report...................................................................................62 SOPs for Data Entry...........................................................................62 Entry Quality......................................................................................62", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Overseeing Data Collection................................................................65", "definition": "Monitoring EDC Data Collection.......................................................65 Monitoring Paper Data Collection......................................................65 Paper CRF Workflow.....................................................................66 Tracking Challenges..................................................................67 Repeating Pages........................................................................67 Pages with No Data...................................................................68 Duplicate Pages.........................................................................68 Studies without Page Numbers..................................................68 Missing Pages Reports...................................................................69 What Pages Do You Expect?.....................................................69 CROs and Tracking Pages..............................................................70 Principal Investigator Signatures........................................................71 Using Tracking for Quality Assurance and Quality Control..............71 SOPs for Overseeing Data Collection.................................................72 Tracking throughout the Process........................................................72", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Cleaning Data.....................................................................................73", "definition": "Identifying Discrepancies...................................................................73 Automatic Checks.......................................................................... 74 Manual Queries.............................................................................. 74 Clinical and Listing Review...................................................... 74", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Problems during Entry from Paper...........................................75", "definition": "Discrepancies Identified by External Programs........................75 The EDC Query Process.....................................................................75 Creating Manual Queries...............................................................76 Resolving an EDC Query...............................................................76 Getting PI Signatures.....................................................................76 The Paper Query Process....................................................................77 Resolving Discrepancies Internally...............................................77 Turning a Discrepancy into a Query..............................................79 Sending Queries to the Sites..........................................................80 Resolving Paper Queries................................................................80 Getting PI Signatures................................................................ 81 Applying the Resolution............................................................ 81 Tracking Queries.................................................................................82 Links to Quality Assurance and Quality Control...............................83 SOPs for Discrepancy Management...................................................84 Using Queries to Improve Efficiency..................................................84", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Managing Lab Data............................................................................87", "definition": "Storing Lab Data.................................................................................87 Advantages of the Tall-Skinny Format..........................................88 Disadvantages of the Tall-Skinny Format.....................................89 Identifying Lab Tests.....................................................................90 Storing Units....................................................................................... 91 Ranges and Normal Ranges................................................................ 91 Laboratory IDs...............................................................................92 Normal Range Storage...................................................................92 Using the Normal Ranges..............................................................93 Lab Result Trends...............................................................................93 Using Central Labs.............................................................................93 Using Specialty Labs..........................................................................94 Auditing the Lab............................................................................94 Monitoring the Data.......................................................................95 Quality Assurance around Lab Data..................................................95 SOPs for Processing Lab Data............................................................96 Why Lab Data Needs Special Attention.............................................96 Chapter 10 Non-CRF Data....................................................................................97 Receiving Electronic Files from a Vendor..........................................97 Transferring Files...........................................................................97 Formatting the Data.......................................................................98 Loading Data..................................................................................98 Identifying File Contents...............................................................99 Cleaning Non-CRF Data..................................................................100", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Why Migrate between Systems?.......................................................230", "definition": "Complex Migrations......................................................................... 231 Migration by Hand.......................................................................232 Migrating Audit Trails.................................................................232 Archiving Data..................................................................................232 Level of Archive Access..............................................................233 What to Archive...........................................................................233 Migration and Archive Plans............................................................234 Future Directions..............................................................................234 Appendix A: Data Management Plan Outline...................................................235 Appendix B: Clinical Data Management SOPs.................................................239 Appendix C: CRO-Sponsor Responsibility Matrix..........................................243 Appendix D: Implementation Plan Outline.......................................................247 Appendix E: Validation Plan Outline.................................................................249 Appendix F: CDISC and HIPAA........................................................................ 251 Bibliography..........................................................................................................253", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Preface", "definition": "conduct and, in all cases, have tried to keep the information practical rather than academic in the hopes that it can be applied by every reader to every CDM group.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Introduction", "definition": "example. (See Chapter 9, \u201cManaging Lab Data,\u201d and Chapter 10, \u201cNon- CRF Data.\u201d) 11. Once the data is in a computer database (through entry into eCRFs or through transcription from paper CRFs), that data goes through vari- ous levels of checks and rechecks until it is considered \u201cclean\u201d enough to support analysis. (See Chapter 4, \u201cEdit Checks,\u201d and Chapter 8, \u201cCleaning Data.\u201d) 12. When all the data from all of the patients has been collected and cleaned, the data goes through a final process that checks the completeness and qual- ity of the data. The dataset is then \u201clocked\u201d against changes. (See Chapter 13, \u201cStudy Database Lock.\u201d) 13. While statistical programs may have been run over data prior to database lock to test the programs and review trends in data, it is not until after the study is locked that the final analysis can be done (with unblinded treatment information for blinded studies). 14. Conclusions can now be reached and the final study report written. Refer also to the diagram in Figure I.1. The Importance of Clinical Data Management The references to particular chapters that appear in the preceding clinical trial flow give an indication of what role clinical data management plays in a clinical trial.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Testing in Humans", "definition": "Drug development begins in the laboratory or on a computer when a company identi- fies candidate compounds to address a particular disease cause, progression mecha- nism, or symptom. If a candidate looks promising, it is moved to preclinical testing; this will involve experiments in test tubes and in animals. The company will also begin to explore manufacturing techniques because a candidate that is not stable or cannot be produced in necessary amounts cannot move forward. At some point, the developer identifies one candidate that can be moved into human trials. An often- cited figure is that for every 10,000 possible candidates, only 5 would be considered safe and practical to consider testing in humans. When a company has such a candidate for testing in the United States, it files an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA). If the FDA approves, testing in humans can proceed. At the point that the drug or treatment is introduced into humans, the experiments are called clinical trials. While there are many exceptions for serious conditions, testing typically begins in healthy volunteers and then, if the drug or treatment appears safe enough and (pos- sibly) effective, testing moves into the target population. Human testing is divided roughly into three phases that are used by both the industry and the FDA: \u2022 Phase I is the first in-human testing. Phase I trials are most commonly con- ducted in healthy volunteers. These are small, short studies that focus on safety and begin to identify appropriate dosing. The studies will also investi- gate further how the drugs act in a human metabolism (pharmacokinetics). \u2022 Phase II involves larger studies of somewhat longer duration in the target population. The participants are carefully chosen and the scheduling of examinations and dosing are carefully controlled. These are sometimes called proof-of-concept trials. The main goals are to show effectiveness of the treatment, gather further safety information, and determine an appro- priate dose.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "xix", "definition": "Just as we sometimes fill in paper forms and sometimes fill in forms online, so it is for clinical trials. Some trials are based on paper forms; others are based on elec- tronic CRFs (eCRFs) and are known as electronic data capture (EDC) trials. (See Chapter 2, \u201cCRF Design Considerations.\u201d)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Getting to a Result", "definition": "The steps involved in getting from an experimental plan (the protocol) to a result that supports or opposes the hypothesis are very similar for each trial that is run: 1. For each clinical trial there is a protocol and a statistical analysis plan, in addition to other regulatory documents, which are completed before the actual experiment begins. 2. When the protocol is final, a team uses it to create a CRF or eCRF. (See Chapter 2.) 3. The CRF/eCRF is used to create a database to store and manage the data. (See Chapter 3, \u201cDatabase Design Considerations,\u201d and Chapter 5, \u201cPreparing to Receive Data.\u201d) 4. In parallel, or after the protocol is final, clinical sites are recruited and they, in turn, obtain approval to participate in the trial and begin to identify and recruit patients to participate in the study as subjects of the experiment. 5. Subjects who are enrolled in the study begin the various visits and proce- dures identified in the protocol. Except in some Phase I studies, the enroll- ment and recruitment are ongoing until the target enrollment numbers are reached. Subjects do not all visit at the same time. 6. At each visit, most of the procedures and results are first documented by site staff on source documentation such as the subject\u2019s medical record\u2014not on the CRF! This is true for both paper and EDC trials. 7. Site personnel transcribe each subject\u2019s data to the CRF or eCRF after the visit. (See Chapter 6, \u201cReceiving Data on Paper,\u201d and Chapter 7, \u201cOverseeing Data Collection.\u201d) 8. Sites are monitored according to good clinical practice (GCP) require- ments to protect the subjects and ensure the trial is being conducted in compliance with the protocol. The sites are also monitored to ensure accurate completion of the CRF or eCRFs. The monitor representing the sponsoring company visits the sites and compares some or all of the source information for all subjects against what was entered into the CRF or eCRF. This is called source document verification or sometimes source data verification and is an important step that has implications for the interpretation of the data. (See Chapter 12, \u201cCreating Reports and Transferring Data.\u201d) 9. For paper studies, the paper CRFs are sent to a data entry center represent- ing the sponsor where all of the data is transcribed into a database. (See Chapter 6, \u201cReceiving Data on Paper.\u201d) 10. For most trials, some data will be received through electronic files from external sources and not on the CRF. Central lab data is the most common", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRF or eCRF designed", "definition": "Study database built and released Data recorded on source documents Data transcribed to CRF or eCRF Source document veri\ufb01cation/monitoring Data entry (paper studies only) Receipt of electronic non-CRF data", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data cleaning", "definition": "Complete and accurate data Extraction for analysis and study report FIGURE I.1 Steps in a clinical trial.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "xxi", "definition": "Clinical data management is the work performed on data from a clinical trial from the preparation to collect that data through the time it is extracted for final analy- sis. (Data managers, however, do not analyze the data.) It will become clear in the chapters that CDM tasks are technical tasks linked closely to computer systems and software applications. Data managers focus on that data including the individual values and the relation- ship of those values to each other. Data management is responsible for delivering complete datasets that are of a quality (accurate, clean) to reliably support a conclu- sion. The importance of clinical data management hinges on the fact that if the data is not accurate, reliable, and analyzable, all the money invested in conducting the study has gone to waste.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study Database Lock", "definition": "131 or the topic can be covered in its own SOP. A controlled unlock process is probably even more important than a controlled lock process. REDUCING TIME TO STUDY LOCK The best way to reduce the time needed to lock a study database is to avoid leaving tasks until the end. This not only helps ensure that the study is locked soon after the last query resolution is received, but it also improves the quality of the data by detecting problems soon after they have been introduced. Companies should con- sider the following approaches to data management tasks that can shorten time to study close. For paper studies: \u2022 Enter data as soon as possible after it is received. Data on paper does not move the process along. \u2022 Run cleaning procedures throughout the study as data is collected so that the queries go out early. Toward the end of the study, the outstanding que- ries should be only those pertaining to recently received data. \u2022 Identify missing CRF pages by knowing what is expected. Use tracking systems. \u2022 Begin to audit data against the CRF (for paper-based trials) early in the study to detect systematic problems. Continue to audit as the study proceeds to monitor quality. For EDC studies: \u2022 Keep on top of SDV status and principal investigator (PI) signatures \u2022 Track the query status throughout the trial even if it seems less important because the site has the queries. For all studies: \u2022 Track all non-CRF data received electronically to identify early missing samples or results. \u2022 Code adverse events and medications frequently. Issue coding discrepan- cies promptly. \u2022 For studies expecting large numbers of SAEs, reconcile periodically throughout the study. Because AE and SAE data often comes in late in the study (because AEs may be ongoing, for example), get listings from the safety system early so you know what to expect. For tasks that cannot be carried out earlier in the study, the best that can be done is to understand the amount of effort involved. At this critical point in a study, when other groups are depending on the outcome and delivery of data, data management must provide as good an estimate as possible for the amount of time required to carry out the tasks properly. 133 14 After Database Lock In the previous chapter we reviewed the activities required to lock a database. The study closeout activities do not end with lock; additional tasks must be performed to shut down a study. These tasks include archiving files, and for electronic data capture (EDC) systems, providing copies of the electronic case report forms (eCRFs) to the sites. In this chapter we also discuss what to do if a problem is detected that requires the database to be reopened for updates to the data.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REVISING THE DMP", "definition": "It is very likely that during the course of an average Phase II or Phase III study, some critical data management process or a key computer application will change. Even though the DMP is a plan, that is, it is the way you expect to conduct the study, it must be revised whenever there is a significant change. The DMP must document how you expect to conduct the study from that point forward. Keeping the DMP current is harder to manage than one might expect. Companies constantly wrestle with finding the best or most practical way to record updates to 6 Practical Guide to Clinical Data Management, Third Edition the data management process. Sometimes the documentation produced by a task is sufficient. For example, additional edit checks can be added to the edit check specification (see more in Chapter 4), and if the DMP simply refers to that document, then no DMP update is required. Similarly, if a company has good change control documentation, it probably is not necessary to update the DMP when the study data- base is modified. If, however, that change control documentation is not sufficient (or nonexistent), the DMP could be updated as the place to record information regarding changes to the study database. In whatever way it is accomplished, after study lock, the DMP together with doc- umentation found in the study files should reflect all important changes to the data management process and computer systems that took place during the study. DMPs AND THE STUDY FILES The SOPs for data management activities and often the DMP specify what output documents are to be created during the course of the study. These are filed in what is known as the study file or data management study file. (This is not the same thing as the trial master file that is managed by clinical operations and contains key study documentation required by good clinical practice [GCP].) The study file may be a folder in a cabinet, a binder in a data manager\u2019s office, or an electronic folder on a shared drive. The DMP and the documents found in the study file must be kept in synchro- nization. If the DMP states that the final database design will be filed in the study file, there must be a folder or tab in the study file for that document. Documents should be added to the study file as required by the DMP whenever they are ready. This makes the study \u201caudit ready\u201d at any time. Compiling the study file at or near study lock is almost a guarantee of finding entire documents or versions of docu- ments missing.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "reason for leaving", "definition": "In designing the CRF, we must always include these implied procedures as well as those found explicitly in the protocol. Once the list of procedures is in place, we have to list all the fields or questions for each procedure. To get those, we go back to the text of the protocol. Where CRF Design Considerations 11 the matrix may say \u201cvital signs,\u201d the procedures section of the protocol should say exactly which vital signs are to be collected. Ideally, the protocol will clearly say whether, for example, blood pressure and pulse rate are required when vital signs are collected or blood pressure, pulse rate, and respiration. CRF designers have to be aware that while vital signs may be collected at each visit, it is still possible that exactly which vital signs are collected may vary from visit to visit and, in fact, vital signs may be collected more than once in a single visit. The clinical teams who write protocols do not always provide the level of speci- ficity that data management requires, in which case the data manager must go back to the study team to completely identify the appropriate fields. Consulting with the clinical team is particularly common for specialized procedures whose results may be obvious to a clinical team experienced in the indication being treated but not necessarily to the data manager, as, for example, in our example of \u201cassess signs/ symptoms of infection.\u201d In addition to getting a complete list of fields associated with a procedure, the data manager will need to know how the result is reported (text, integer number, decimal number, etc.) and what the typical units are. Later in the study startup process (see Chapter 4), the data manager will again come back to these fields and ask the study team to identify what normal or expected ranges apply to the reported results and", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FIGURE 2.1\u2003 This table is a subset of a protocol visit/procedure matrix showing only Days", "definition": "3 and 4 from a fictitious study of a treatment for skin infections. In this example, a physical exam is not performed on either Day 3 or Day 4, but presumably would be done at the start and possibly the end of the study. Several other procedures such as Blood Culture appear on both days. Several, such as ECG, appear only on Day 4, not on Day 3 (and of course they could also be performed on days outside of our subset). 12 Practical Guide to Clinical Data Management, Third Edition what kinds of logical consistency with other fields are assumed (e.g., systolic blood pressure is greater than diastolic blood pressure). This process of determining the structure of the CRF from the protocol should ensure that all the data required by the protocol is actually being collected in the CRF at all the required time points in order to satisfy one of the primary goals of CRF design. It is worth noting here that clinical teams should be discouraged from collecting data \u201cjust in case it proves interesting.\u201d Every data point collected has a cost associated with it\u2014the database field must be programmed, cleaning rules written, source documents verified, discrepancies followed up, and analysis pro- grams developed. The cost matters for companies both large and small. If it might be interesting, it should be included in the protocol and fully supported in collection and data cleaning. That being said, a few fields on the CRF collect data that is not analyzed; some fields are used to check compliance with the protocol and some are used to assist in cleaning the data. These kinds of fields are discussed more in the following sections.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Volume Collected", "definition": "1/22/2011 14:30 19:00 \u2014 1/22/2011 19:00 22:20 \u2014 1/22/2011 22:30 04:45 \u2014 1/22/2011 04:45 10:10 \u2014 1/22/2011 10:10 15:30 \u2014 FIGURE 2.2 A re-creation of an actual CRF designed to track urine collection. This CRF form generated a large number of queries because sites were asked to duplicate data\u2014the stop time from one row was nearly always to be copied to the start time at the next row without a gap. Note an example of a typo in the third row, highlighted, that would have to be queried. In addition, the date was to be entered at the start of each row and sites frequently forgot to change the date after midnight on the first collection day as shown in the highlighted cells in rows 4 and 5. 16 Practical Guide to Clinical Data Management, Third Edition While having a single missing value here and there is to be expected, it is also worthwhile to make accommodations for an entire set of questions to have no responses. When questions on a page are logically connected, they are usually grouped into a module and often visually linked via a box around the group. For an EDC study, they would appear together on a single eCRF form. If it is in any way possible that the site will have no responses for the entire module, consider including a not-done box for the module or an indicator at the start of the eCRF form. If the not-done box is checked, no discrepancies will be raised when the values are blank. To make this concrete, let us consider the case of some laboratory values that come from a single blood draw and are evaluated by a local site laboratory. If one of the required values could not be obtained, the site could write NA for the result on a paper form. If, however, the site was not able to obtain a blood sample, they would have to write NA for each result or mark a not-done box for the entire lab result group of fields. The module not-done box can be taken up a level, because ambiguity of missing values can also occur at the page level. For example, some adverse event forms have a header section followed directly by the fields used to report adverse event data. If that page or form data comes in to data management with all header information filled in but the rest blank, there is no way of knowing if there were no adverse events or if the page was inadvertently left blank. Other types of important data, such as hospitalizations or concomitant medications, are collected on pages that have the same characteristics. These kinds of pages or modules should have an indicator field after the header that asks \u201cWere there any adverse events?\u201d (or medications, or hos- pitalizations). To be consistent with the previous suggestion, the indicator variable should have both a YES and a NO box to ensure the response is unambiguous. CRFs WITH DATA PROCESSING IMPACT Certain kinds of CRFs or eCRFs may be necessary and appropriate but still have a significant impact on the way the study is processed. When reviewing CRFs for a", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Discharge", "definition": "\u25a1 Several options would make the response unambiguous, including: \u2022 YES and NO boxes for each question \u2022 A \u201ccheck if none\u201d box at the beginning or end of the list \u2022 A preliminary question such as: \u201cWere any of these symptoms present? Yes \u25a1 No \u25a1\u201d FIGURE 2.3 In this example, if none of the symptoms were present, the entire section would be blank. This represents an ambiguous response\u2014did the site overlook it or were no symptoms present? CRF Design Considerations 17 study, data managers should keep an eye out for these kinds of designs and plan for their impact\u2014not just on one particular data value or set of values, but also on the flow of the data through the trial. Examples of designs that impact processing include: \u2022 Log-type forms for AEs, etc. \u2022 Questionnaires \u2022 Diagrams or analog scales \u2022 Early termination pages In the following sections we look at these in more detail with considerations for paper and EDC trials.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REVISIONS TO THE CRF", "definition": "During the course of the study, a clinical protocol may change in such a way as to impact the CRF pages. Two common changes are the addition of lab tests and changes to the inclusion or exclusion criteria. Whenever a revision to a CRF page or screen is required, the data management group together with the clinical team members must evaluate the appropriate course of action and thoroughly understand CRF Design Considerations 21 the implications of the change. Both paper and electronic CRFs will require a data- base change (see Chapter 25, \u201cChange Control\u201d). When site level institutional review board (IRB) approval is required, distribution of paper pages is easily managed. For EDC studies, however, the EDC software system will determine if site-by-site level roll out of changes is even possible or if all approvals must be received before the changes are made available to sites. For both EDC and paper, the clinical team should think through handling of pages and data that already exists: \u2022 What to do about pages/forms already containing data; must they be tran- scribed or reentered? \u2022 For new fields, will existing subjects be queried to fill in the data (paper) or asked to go back and fill in new fields (EDC)? \u2022 For paper-based studies, will both old and new pages continue to come in or will blank pages be swapped out so only new pages will come in going forward? \u2022 How are data cleaning rules (edit checks) affected\u2014add, delete, or modify cleaning rules? \u2022 Can the change impact queries already open at the site? \u2022 How about existing data; are any new manual queries required to confirm previously received data based on new protocol requirements? Clearly, a careful coordination between the clinical and data management team members is essential. It is fairly common for a question to arise after a CRF change regarding the ver- sion of the CRF page that was used by a site for a given subject. Consider storing the CRF version information in one of the systems being used in data management, or at least the version after a revision. Many statistical programmers like having the ver- sion number with the data in the database in studies where the CRF changes impact how the data will be reported. QUALITY ASSURANCE FOR CRFs Having experienced members of the CRF team carefully review each page and the complete booklet or visit structure is the best form of quality assurance for CRF design. As a team or as individuals they should be checking the following: \u2022 That all tests and data required by the protocol are found at the appropri-", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ate visit", "definition": "\u2022 That the data to be used in analysis is actually being collected \u2022 That standard or historical CRF modules have been used, if they are available \u2022 That checklists or codes for categorical fields are consistent within this study and across related studies \u2022 That instructions printed on the CRF are clear and unambiguous Teams typically perform this kind of review on unique pages or forms, but some of these will appear multiple times in a study, such as vital signs collection that might 22 Practical Guide to Clinical Data Management, Third Edition appear at every visit. At least some of the team members should be sure to view the entire CRF booklet or study eCRF to check that the modules all appear as required.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs ON CRF DESIGN", "definition": "A standard operating procedure (SOP) on CRF design or eCRF specification will likely be a cross-functional one developed and approved by all groups involved. The content of the SOP can be fairly light, perhaps only outlining the expected flow from who is responsible for initiating and/or leading the process through all the people that will sign off on a final version. Many companies require a review against com- pany standards early in the development process. There must be a procedure in place for amending the CRF and approving that amendment. All versions of the CRF must be stored in the clinical data management or trial master files. REUSE AND REFINE CRF MODULES Companies, not just data management groups, benefit from the use of standard mod- ules for CRF design. When a standard module is used, the completion instructions are the same, the database design is the same, the edit checks are the same, and the associated listing and analysis programs are the same. It is also easier to com- pare or combine data across studies. Medium and large-sized companies typically have a standards reviewer and sometimes a process for requesting deviations from standards from a committee to ensure that individual studies get the benefit of the standard sections. While reusing standard sections has high value, a very common problem that companies face is not changing a module when it is not working. If data management has found problems processing data from a certain CRF module, it is clinical data management\u2019s responsibility to take that into consideration and refine the module for the next study or to request changes from the standards committee. 23 3 Database Design", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Field Data Types", "definition": "Specifying the data type of a field tells the database what kind of response is expected, and so defines storage characteristics as well as properties or attributes of the data. For example, numbers can be multiplied together but texts cannot. Dates can be subtracted to give you the number of days in between, but adding them does not work. You can do spell-checks on texts. In the chapter on CRF design, we talked about collecting analyzable data and how that translates into the need to know what the data type of the responses would be. To do numeric analysis, we needed to collect numeric data, not text. When we design a paper CRF we lay out a place for a field on the page; when we design the database, we specify that the field will be a numeric field. In some systems, it will only be possible to type a data type consistent with the database field definition into that field; in others it will be possible to store it, but it will be flagged as being unacceptable and will not be included in analysis. In the next Database Design Considerations 25 sections, we look at the most typical data types for fields (numeric, date, and text) and the design considerations associated with those data types. Some databases have other data types for clinical data, including coded; coded data is also discussed in the following sections. After defining each type, we will look at potential problems and limitations associated with fields of that type.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DATE", "definition": "06/12/1998 06 12 1998 06/12/1998", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FIGURE 3.1\u2003 An illustration of using a set of fields to avoid problems in collecting and stor-", "definition": "ing incomplete dates. 28 Practical Guide to Clinical Data Management, Third Edition Another problem that can arise for larger global studies is the limitation some databases have regarding the format used to enter dates. In the United States, dates are often entered using a mm/dd/yyyy format, where 07/04/2001 is July 4, 2001. In Europe, the format is more typically dd.mm.yyyy, where 04.07.2001 is July 4, 2001. Some companies, when faced with limitations on entry of dates, are moving to a more global ddMONyyyy (04JUL2001) format, which seems to be well received by most sites.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Texts", "definition": "Text fields are very flexible as there are almost no limits on the contents of a text field. But, even text fields have their problems, and they are all associated with length. For most databases, the designer specifies a maximum length for the field. While there is plenty of space on servers to store large text lengths, longer fields do adversely affect the display of the contents on the screen, in reports, and in analysis datasets. So, the designer selects a reasonable number of characters based on previous experience. Every so often, data will come in that is longer than the specified length, meaning the database must go through a modification to widen the field in the database to store the longer text. As we will see in Chapter 25, \u201cChange Control,\u201d a field revision can be a time- and resource-intensive task, so to avoid a change for a single value, the monitor will often work with the site first to see if it is possible to arrive at some equivalent, but shorter, text. The longer the text the bigger the problem: even when database storage has been appropriately defined to capture longer text fields, some query tools and analysis programs have limitations on the length of text fields to which easy access is pro- vided. That is, very long comments take more work to extract and display. A char- acter length of 200 is one of the common limits. In some situations the combination of database limitations and reporting tools will make it necessary to have several numbered text fields (e.g., Text1, Text2, etc.) to store a long text. A series of related text fields has several drawbacks. The designer must guess the number of fields to create, and data entry staff or the site must determine the best way of breaking up the text between lines. Also, review of the complete text requires the extraction and reformatting of the entire set of fields, which usually makes ad hoc retrievals of the text impractical.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Coded Data", "definition": "In clinical trials, many fields have a limited set of possible responses and most clini- cal database applications have a special type of field \u201ccoded\u201d to support these called. Common examples of coded fields include yes/no answers, male/female for gender, and mild/moderate/severe for severity. For coded fields, it is usually not possible to enter a value outside of the list of acceptable responses, which is typically known as a codelist. In most systems, codelists have values that are displayed and values that are stored, and they do not have to be the same data type. A codelist for severity might be MILD=MILD, MOD=MODERATE, and SEV=SEVERE or it could be 1=MILD, 2=MODERATE, 3=SEVERE. The numbers that are stored in the second example Database Design Considerations 29 have the nice property of sorting in increasing severity. Whenever data is displayed or reported, the stored value must be decoded. Most software used by biopharmaceu- tical companies has this functionality built in. Coded fields are meant to be used in cases where the response is a single value selected from a list (\u201cSelect one \u2026\u201d). When more than one answer from the list is possible, the database design changes from a single field associated with a codelist to a series of fields, each of which may be yes/no. See Figure 3.2 for an example. Data management challenges for coded fields arise when the response frequently falls outside the predefined list. It is most common to add a code for the category \u201cother\u201d when the designer expects that sometimes the responses provided may not cover all the possibilities. When the choice of \u201cother\u201d is provided in the codelist, the designer frequently adds a text field to the collection form identified as \u201cif other, specify\u201d to allow entry of a short free text. There are specific statistics that apply to fields that are categorical like coded fields, but they won\u2019t do much good if a high percentage of the responses fall into the \u201cother\u201d category and show up in the", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SINGLE RESPONSE", "definition": "CRF/eCRF Treatment required (check one): [ ] None [ ] OTC [ ] Prescription Drug [ ] Hospitalization [ ] Non-drug Therapy", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Database Design", "definition": "TRT_REQ defined as a coded numeric field TREATMENT codelist defined with the possible values: 1 NONE 2 OTC 3 PRESCRIPTION 4 HOSPITALIZATION 5 NON_DRUG_THERAPY", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MULTIPLE RESPONSES", "definition": "CRF/eCRF Treatment required (check all that apply): [ ] None [ ] OTC [ ] Prescription Drug [ ] Hospitalization [ ] Non-drug Therapy Database Design #1 TRT_NONE defined as a coded field with YES/NO TRT_OTC defined as a coded field with YES/NO TRT_PRESCRIPTION defined as a coded field with YES/NO TRT_HOSPITAL defined as a coded field with YES/NO TRT_NON_DRUG defined as a coded field with YES/NO Database Design #2 TREATMENT defined as a single text field; entry staff enter a string of comma-separated numbers, such as \u201c2, 3\u201d. FIGURE 3.2 An example of a database design for a coded field with a single answer and two designs that permit multiple answers. Notice that the CRF page or form is the same except for the instruction text. This example refers to a treatment-required field typically found on adverse event CRF pages. 30 Practical Guide to Clinical Data Management, Third Edition additional field. It is worth noting that if the data manager reviewing the data notices certain values in the other-specify field that show up frequently, it would be worth considering adding codes to the codelist through a database revision. Another problem that can arise with codelists is when the list gets too long. For example, if a sponsor decides to categorize the location of a lesion on the body, and the entire body is possible, the list could get too long. If the site cannot easily see an overview of codes and cannot quickly find the appropriate code, they may pick the wrong one. The meaning of too long is dependent on the type of information in the codelist, but the clinical team should consider using a different approach if the number of options or codes goes above 20. The options for long lists of codes or responses would then be free text, which cannot be analyzed at all, or a field that is automatically coded (autocoded); that is, the short reported text is automatically checked against a large codelist by the computer system. Large codelists (sometimes called dictionaries or thesauri) are standard for a very common class of short free- text fields that need to be categorized: adverse events, medications, and diagnoses. These kinds of free text are often called reported terms, and the matching of the terms to a dictionary is a complex coding process. See the coding section of Chapter 11, \u201cCollecting Adverse Event Data,\u201d for more information on coding reported terms and Chapter 26, \u201cCoding Dictionaries and Systems,\u201d for more information on how dictionary coding works.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit", "definition": "BP_ DIA_1 BP_ SYS_1 BP_ DIA_2 BP_ SYS_2 BP_ DIA_3 BP_ SYS_3 1001 2 120 72 118 70 117 68 Data Storage in One Tall-Skinny Form", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CHOOSING EDIT CHECKS", "definition": "After the database is fully defined (although perhaps not yet built), the data manager will go through every field and determine what assumptions are to be made about data values in that field. Some of these assumptions will be enforced by the database itself and do not have to be defined as an edit check. For example, fields defined as dates will automatically restrict values to valid calendar dates and coded fields will restrict responses to the values in the codelist for that field. Most other assumptions on the data such as valid ranges will be programmed to run within the database or EDC system. Those that are difficult to program within the limits of the system will be run outside the database or EDC system in programs such as SAS\u00ae. A few checks require medical knowledge or other human insight and will be performed manually. In deciding on edit checks for a given study, a clinical data manager can use these categories to help identify the necessary checks: 38 Practical Guide to Clinical Data Management, Third Edition \u2022 Missing values \u2022 Simple range checks \u2022 Logical inconsistencies \u2022 Cross-form or cross-page checks \u2022 Protocol violations", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Missing Values", "definition": "For fields where we always expect to have a value, we can impose a missing value check. That is, a discrepancy (see Chapter 8) will be raised if the field is left blank. For example, we always expect a value for visit date since that is a known piece of data for which source documents would exist. The data manager would either specify in the database design or as a separate edit check that a value for visit date cannot be missing. Care has to be taken when defining a required field at the database level rather than as a postentry check. If a field always requires a value at entry, it cannot be used for a field where there is a chance that the data is, in fact, not available. So for paper-based studies in particular, where data is entered from a case report forms (CRF), it is best to check for missing values after entry through an edit check.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Simple Range Checks", "definition": "Ranges are a very good way of checking numeric data to identify typos and to flag potentially incorrect values. An example of a range check for weight in kilograms is to flag data when the weight of an adult is outside the range of 45 kg to 200 kg. While it is possible for a person to be heavier or lighter, a double check with the site is appropriate. It should be noted that the ranges must not only be appropriate to real life but should also be sensitive to the patient population with the indication being studied. If a study had children as subjects, a lower range limit of 30 kg could raise too many queries for perfectly acceptable values. Dates can also have ranges but they are more typically relative to the subject\u2019s course in the study and are discussed more in the following sections in logical and cross-form checks. As with the missing fields, some databases allow fields to have hardwired ranges associated with the database itself rather than as a postentry check. If that is the case, the database designer must take care to allow the ends of the ranges to be exceeded, overridden, if it is at all possible that the value really does fall outside. Softer ranges at entry to detect typos and tighter ranges programmed as edit checks are a better choice. Logical Inconsistencies This is a very broad area of edit checks that is the hardest for new data managers to apply. Logical inconsistencies are possible all through the data because there are assumptions behind most fields that go beyond whether a field can be blank and the value must be in a reasonable range, but it takes practice to be able to identify them. Here are several examples of logical assumptions representing various data types:", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Edit Checks", "definition": "Edit Check Specification, EDC tab", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs FOR EDIT CHECKS", "definition": "Every company should have the process for defining and building edit checks cov- ered in a standard operating procedure (SOP). The SOP might be the study database", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DEMOG", "definition": "DOBD_MISSING Date of birth is missing or incomplete. The subject\u2019s date of birth is missing or is incomplete. Please clarify.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Auto", "definition": "FIGURE 4.1 Example of an edit check specification table for some demographics information. In this example, the system allows for naming each check for ease of reference and copying. The \u201cmethod\u201d column is auto for system checks. 42 Practical Guide to Clinical Data Management, Third Edition specification and build SOP or an SOP specific to edit checks. An edit check spec, under any appropriate name, is considered an industry standard document crucial to producing quality data and should exist for every study. Key members of the clinical team including the clinical trial manager, biostatistician, and statistical programmer should review and approve the edit check spec along with the data manager. Many companies also require that the medical monitor review and approve the checks. THE CONNECTION TO QUERIES The edit checks in the edit check spec are programmed into the system. For paper- based studies, the checks will raise discrepancies when data is found that fails the check. All of these discrepancies will be reviewed by data management and many will be sent to the sites for resolution. For EDC systems, the checks will immediately raise queries to the site. There is a cost associated with all queries. Some are process- ing costs, which can be quite large for paper studies. For EDC studies, there is an \u201cannoyance factor\u201d for the sites. When specifying checks, make them count; avoid: \u2022 Ranges that are too tight \u2022 Raising multiple queries that are all due to a single field in error \u2022 Excessive checking of data that is not a primary or secondary endpoint When we specify edit checks, we also program a default query message; good practices for wording queries are discussed in Chapter 8. 43 5 Preparing to", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Paper Studies", "definition": "Chapter 3 introduced the concept of designing a database before building it. The design process results in a specification of the database to be built. For paper studies, specification is most typically an annotated CRF and may or may not also include a more detailed design document. In clinical data management, the annotated CRF is usually a blank CRF that has written on it (by hand or as an electronic overlay) the names of the database column, field, or item associated with each CRF field. The 46 Practical Guide to Clinical Data Management, Third Edition CRF page is also clearly marked to show how questions are grouped into modules or tables. Because the annotated CRF is used not only by the database designer but also by edit check writers, entry screen designers, and even those browsing data through database queries, it is helpful if the codelists associated with an item are present along with any hidden, internal, or derived fields associated with each module. The use of annotated CRFs for paper studies is widespread enough to be considered industry standard practice. A separate design document, while not required by all data management groups, can provide information that is not readily obvious from the annotated CRF. This document might include simple overview information such as the list of all group- ings or tables and the names of all codelists used. In companies where there are firm CRF page and database standards, the design document can focus on deviations from those standards (if any) and introduce any new objects created specifically for this study. It might also include a more detailed discussion of design decisions that were made for problematic fields or tables.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EDC Studies", "definition": "There is less consistency across companies for what acts as a database design for EDC studies. The document can look like an entry screen (eCRF) or not, but it usu- ally includes detailed information about the database design and often about the structure of analysis datasets created from that design. After the database is built, EDC systems can generate a blank eCRF, analogous to a paper CRF, which can be used to train sites. The EDC system can also create an annotated CRF with data- base attributes printed on the fields. That an annotated CRF is considered a feature of EDC systems, demonstrates the value of the annotated CRF for many different activities related to any CDM system! How Building Impacts Specifications The database builder uses the specifications (annotated CRF for paper or other docu- ment for EDC) to create the database objects for a study. The building process itself acts as another form of database review. The builder may notice a problem with the design or may not be able to implement the object as specified. The builder and designer then work to come up with a solution, updating the specification documents appropriately. When the system is deemed ready to test, a version of the specifica- tion documents must match the built version so the testers know what the expected behavior is. TESTING STUDY DATABASES Validation always involves testing as one element of the process, and all study data- bases should be tested\u2014without exception! A mistake in creation of the database or a poor design choice will impact data storage and possibly analysis. Testing aims to identify these errors before production data is stored in the application so that changes can be made without impacting live data. Just as with software system Preparing to Receive Data 47 testing, one has to take a practical approach and decide what kind and what amount of testing is most likely to identify problems, without taking up too many resources and too much time.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Testing Environment", "definition": "Typically, the builder will work in a development environment that mimics the actual production environment; that is, the software system and standard objects are the same but development work is taking place \u201con the side.\u201d When the application is ready for testing, that testing may take place in the development environment, another area specifically set up for testing, or in appropriate circumstances, the pro- duction environment itself. If the study is tested outside of the production area, the move to the production environment must be a controlled and reliable one.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Testing Paper Studies", "definition": "Testing of a study database for a paper study most naturally takes place when the entry screens are ready and uses patient test data written on CRFs. Depending on the complexity of the study, data management groups will typically test from 2 to 10 subjects\u2019 worth of data. If the goal is purely to test the entry screens, the test data will be mostly normal data with typical exceptions in date formats or text in numeric fields. Some companies use data that will later be used to test edit checks as test data, in which case many values will be chosen to later fail the edit checks. Ideally, data entry staff will perform the entry of the test data as if it were real. Any problems that they identify in the fields or in the flow of the screens should lead to corrections and an appropriate level of reentry of the test data. But the testing does not stop once data entry is flowing smoothly. After the data has been entered, the responsible data manager should run the process or programs to fill in any derived or calculated fields. Then, a tester should compare data extracted from the database against the original test CRFs as if this were a database audit. In addition to looking to see if the data values match, the tester is also checking: \u2022 Is the data stored in the correct field? \u2022 Are the calculated variables calculated and correct? \u2022 Are all hidden variables filled in as specified? \u2022 Has any data been truncated or otherwise improperly stored? \u2022 Are there unexpected blank records? \u2022 Are fields that should be carried over to multiple rows or groups prop- erly carried? There may also be additional checks that are related to the application used to capture the data. This step of comparing the extracted data to the original is often overlooked but should be considered the real evidence of a functioning study. Finding any of the problems previously discussed is a very serious situation and it may be impossible to correct once data is in production. 48 Practical Guide to Clinical Data Management, Third Edition", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Testing EDC Studies", "definition": "Testing for an EDC study would typically be even more thorough than for a paper study because the database is used directly by inexperienced users at the sites. Testing strategies vary; some companies perform extensive entry testing as if it were a paper study, others test the database design without entering data typical for a trial subject. When the specification of the extracted dataset is included in the database design, entering typical data and extracting it as described previously for a paper study should be considered an essential part of testing. Because edit checks are built into the entry screens for EDC studies, these must also be tested before the system is released for subject data. In many cases, testers will use the edit check specification as a guide (see Chapter 4) to enter data into a single field that passes the check and then some that fail the check. They also attempt to leave fields empty where data is required and check edge values on ranges. Given the many hundreds of edit checks for a typical study, this is a very time- and resource-intensive task. Many sponsors new to EDC contract with a contract research organization (CRO) or an EDC vendor to have a study built. Sponsors should expect the vendor or CRO to undertake extensive testing, and in addition, they should expect to be asked to par- ticipate in additional testing, often called user acceptance testing (UAT). The CRO or vendor uses UAT to ensure the sponsor sees the final, implemented eCRF. This is analogous to having the sponsor sign off on CRF design undertaken by a CRO. Some sponsors report that the study-build vendor expected much more extensive testing than they expected\u2014more in line with the study validation testing just described. Both sponsors and vendors should be sure to make very clear in the contract or state- ment of work for the project what kinds of testing will be performed and which side will carry out that testing. Final Steps in Testing Throughout testing, someone, usually the data manager, keeps track of all issues or deviations from expected behavior. Some of the issues may be an error in the study build, some may be an error in the specification, and some may be due to differences in interpretation of expected behavior. The data manager, in consultation with appro- priate roles involved in building and testing, assesses each issue and determines an appropriate course of action. The study database may be corrected, the specification may be updated, or there may be a bug report for the software system itself. Before the system is put into production, all of the issues should have been addressed and the specification and the study database should match.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MOVING TO PRODUCTION", "definition": "We know that validation is not just testing. Therefore, completing the testing does not mean that validation is complete. Most auditors expect an official statement that the study is ready to put into production. This step often comes after all the test- ing issues have resolved and a (brief) summary written. Some kind of approval of Preparing to Receive Data 49 the results and summary is appropriate. For databases supporting paper studies, approval is typically within CDM only. For EDC studies, approval may also include roles outside of CDM who were involved in testing, such as the clinical team lead. Since validation requires documentation of each step, the test data and results should be filed in the data management study file as evidence of the process. Training in the use of systems that generate electronic records is required by 21 CFR Part 11. For paper studies, training focuses on entry staff (who would pre- sumably have already had training on the application). This training is not a com- plex formal training on the application and company standards; rather, it focuses on study-specific issues. Typical preproduction entry training will include a discussion of difficult or nonstandard entry screens and a review of standard and study-specific data entry conventions or guidelines. Evidence of the training should be filed in the study file or in each employee\u2019s training binder. Frequently, a CDM group will also require a record of signatures and initials in the study file for anyone who will work on the study; this is a good point at which to collect the initial set. It is a best practice for entry staff to be given access or permissions to the production study only after training. (For more on training, see Chapter 16; for more on security and accounts, see Chapter 17.) For EDC studies, the focus is on the sites as they will be doing data entry. They require training both to use the EDC software and on the study in question. Principal investigators also need to be trained on the electronic signatures that all EDC sys- tems feature to satisfy requirements of 21 CFR Part 11. (Paperwork documenting the principal investigator\u2019s signature and understanding of the electronic signatures is also required by regulation.) As in paper systems, accounts to do work in the produc- tion database should only follow successful completion of training. In addition to training, it is quite common to have additional requirements that must be met before production use of a study application. These may include, for example: \u2022 Moving the study database into a production area \u2022 Setup of related tracking and reporting applications for the new study \u2022 Initiation of interactive voice response systems (IVRS) applications for", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study Conduct", "definition": "Once subject data begins to come in to the CRO, questions will arise. The sponsor\u2019s data management liaison must be available to answer these questions. The CRO lead", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TRANSCRIBING DATA", "definition": "Accurately transcribing data from the CRF to the database is essential. Errors in tran- scription are usually due to typographical errors (typos) or illegibility of the values on the CRF. Companies aim to reduce transcription errors using one of these methods: \u2022 Double data entry with third-party reconciliation of differences \u2022 Double data entry with a second person resolving differences \u2022 OCR as first entry with one or more subsequent entry or review passes \u2022 Single entry with extensive data checking Even after transcription errors are reduced to a minimum, there remains some variation in what an \u201caccurate\u201d transcription means. Does it mean that the data is an exact dupli- cate of the values found on the CRF, or are there deviations or variations permitted?", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Double Entry", "definition": "With an error rate often given as 0.1%\u20130.2%, double data entry has long been used as a reliable method of transcription. In double entry, one operator enters all the data in a first pass, and then an independent second operator enters the data again. Two dif- ferent techniques are used to identify differences and to resolve those differences. In one double entry method, the two entries are made by different entry operators and both values are stored. After both passes have been completed, a comparison program checks the entries and identifies any differences. Typically, a third-person reviews the report of differences and makes a decision as to whether there is a clear 56 Practical Guide to Clinical Data Management, Third Edition right answer (for example, because one entry had a typo) or whether a discrepancy must be registered because the data value is illegible or is in some other way unclear. This method of double entry is sometimes known as blind double entry since the operators have no knowledge of each other\u2019s work. The other double entry method uses the second entry operator to resolve differ- ences. After first pass entry, the second entry operator selects a set of data and begins to reenter it. If the entry application detects a mismatch, it stops the second operator who decides, right then and there, what the correct value should be or registers a dis- crepancy to be resolved by a third person. This double entry method does not have a common name but will be referred to as heads-up second entry. Blind double entry is well suited to the use of temporary or untrained staff for both entry passes. A more experienced operator or coordinator acts as the third per- son reviewing only the differences identified by comparing the passes. Heads-up second entry works best if the second entry pass is performed by a more experienced operator, but many companies have seen good success with this method even when using temporary staff. If the entry application supports it, it would be worth consid- ering using different methods at different times or with different studies, depending on available staff. Extensive checks at entry time are rarely incorporated into entry applications when data is to be entered in two passes. A check at entry would only slow down the operators and would bring little value. Checks on the data are run after differences have been resolved.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "OCR Plus Review", "definition": "Optical character recognition (OCR) is a technique whereby software attempts to read text in a document. OCR has been used for many years to successfully read pre- printed header information. As the software has improved, it has also been used to identify handwritten numbers and marks in check boxes. However, success rates in reading handwritten free text are still rather poor. As more companies move toward imaging or fax-in of CRFs, the opportunity to use OCR has increased. When used, OCR becomes the first data entry pass on numbers and check boxes and is followed by at least one other pass to verify those numeric values and fill texts or other fields that could not be read by the OCR software. The second-pass operator (after OCR) visually checks values read by the OCR software and types in any text values that appear on the form. Sometimes, the OCR software will provide an indicator of how sure it is about reading each value to guide the operator to fields that need review. Because the visual verification is hard to enforce and because the operator may fill in a significant number of fields, there is a danger of introducing transcription errors. Companies generally address this by doing yet another pass and also by including extensive postentry checks.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Illegible Fields", "definition": "Illegible writing on the CRF always causes problems for data entry, data man- agement staff, and clinical research associates (CRAs). Each data management group should consider the following questions when planning an approach to illegible fields: \u2022 Can entry operators discuss the value with each other? \u2022 How do entry operators indicate illegibility at second pass? \u2022 Leave the field blank? \u2022 Guess and flag the field? \u2022 Type special flagging characters (e.g., ###)? \u2022 Should data managers make educated guesses based on a review of other pages? \u2022 Can the CRA make a decision based on medical information or experience with the site? Even when staff tries to appropriately identify values, some data is just illegible and will have to be sent back to the site for clarification during the data cleaning process.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Notations in Margins", "definition": "Investigators will sometimes supply data that is not requested. This most frequently takes the form of comments running in the margins of a CRF page, but may also take the form of unrequested, repeated measurements written in between fields. Some database applications can support annotations or extra measurements that are not requested, but many cannot. If site annotations are not supported, data management together with the clinical team must decide what is to be done: Receiving Data on Paper 59 \u2022 Can the information be stored in the database as a comment or annotation (but then it could not be listed or analyzed)? \u2022 Can the comment be ignored? \u2022 Should the site be asked to remove the comment or transcribe it some- where appropriate? Many data management groups do not store unexpected information at all, but since it can contain medical information, senior data managers and/or CRAs will review the extra comments and measurements to look for important safety information.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit Plan", "definition": "The number most frequently used in selecting the data to sample for an audit is 10%. This is often supplemented by a 100% audit of safety fields such as those for adverse events. Some companies also audit 100% of a selection of key efficacy fields and/or primary and secondary endpoints. It is very important to note that a 10% audit still Receiving Data on Paper 61 does not tell us exactly what was or will be audited. Is this 10% of the subjects, full CRFs, pages, or data? Ten percent of the subjects may be easy to select, but does not guarantee good coverage of investigator sites. Small studies also require more coverage so when the number (N) of subjects is small, the sample taken is the square root of N minus one. Ten percent of CRF pages, chosen randomly across all subjects, provides an excellent sample but is hard to audit when the CDM system does not retain the link from page to dataset. Similarly, ten percent of data from a dataset also provides a good sample but it can be difficult to pull the pages if the system does not retain the link. Many companies say that their acceptable error rate is 1%\u20135%. This is, however, much too forgiving an error. For data as well controlled as clinical data, a wide vari- ety of journal articles say that errors should be limited to 10\u201350 per 10,000 fields. This translates into 0.1%\u20130.5%. This latter figure also is in line with numbers for high-quality double entry in any industry and should be a good and reasonable target for most organizations.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit Process", "definition": "To perform the audit, a data manager or programmer takes the sample size and method (by page, by subject, etc.) and randomly selects the data to audit. That data will have to be listed in a report of some kind for use by the auditor. Ideally, the list- ing will present the data in such a way as to make comparison to the CRFs as easy for the auditor as possible, as opposed to whatever is easiest for the programmer in order to keep auditing errors to a minimum. The auditor will take the listing and compare it to the CRF data, marking any differences that are not accounted for by data entry instructions. These differences are not yet errors! It is possible that these differences come from corrections to the database made during the cleaning process as the result of a self-evident correction or response to a query (see Chapter 8). The auditor then looks at any evidence from cleaning, such as query forms associated with the page, and determines if these can account for the differences. If any discrepancies between the database and the listing remain, the auditor must ask one final question before declaring them to be discrepancies: Have these differences been introduced by errors in the programming that created the listing? After eliminating this final source of differences, those that remain are documented by the auditor as true entry errors. When the auditor has worked through the entire data sample, the information goes back to the data manager who reviews the errors and the differences marked as not-errors. This should give the data manager a sense of where the errors are occur- ring. The data manager then divides the total number by the total number of fields in the sample to give the error rate. One important caution here: calculating the total number of fields is not simply multiplying rows by columns in a database listing. For a typical study, that method would overestimate the number of fields entered rather than those that appear in the listing and produce a better error rate than is warranted. During entry, the subject identifier would be entered only once per page or in some systems only once per subject, but in a typical listing the subject identifier would appear on each row of data. Also to consider are the fields that are prepopulated by 62 Practical Guide to Clinical Data Management, Third Edition the system because they are preprinted on the CRF and prefilled in the entry screens to provide them in the data for analysis (e.g., time points for taking vital signs). Once these computer-supplied fields are all taken into account, we have arrived at a more accurate picture of data entry errors for a given study.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit Report", "definition": "The audit report is essentially a cover memo to the actual audit listings. It lists the number of errors, the number of fields counted, the final error rate, and any action taken. The package consisting of the audit plan (if not an SOP), audit listings, and audit report are filed in the study files to show evidence of the quality of the data. One tenet of quality assurance and quality control is feedback. When errors are found, they should be used to improve the process. Even when the error rate is acceptable, it may be possible to detect some identifiable source or sources of errors. Retraining of data entry staff or data managers is always a possibility. It is also com- mon to provide feedback to CRF and database designers. What is to be done if the rate as a result of the audit is unacceptable? If the audit is early in the data management process, it may well be possible to correct or adjust the process or systems to remove some of the sources of error. If the audit is performed at the end of the study, it would be advisable to increase the number of fields audited to confirm the rate. Some companies immediately move toward performing a 100% audit of all of the data when the error rate is exceeded. Other companies perform another 10% sample. Still, others examine the result first and try to determine if any particular type of data or specific data modules are the source of the problem and then conduct a 100% audit of just that data. Because audits are very resource and time intensive and because identifying the cause of errors has a high value, spend- ing time analyzing the audit results instead of just reporting the numbers can have a major impact on data entry efficiency.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs FOR DATA ENTRY", "definition": "At companies with a very consistent entry process, the process itself may be laid out in an SOP. For example, a data entry SOP may always require blind double entry with third-party arbitration of discrepancies. It may also indicate the level of preen- try review and outline the audit process. At companies with variations in data entry across groups or studies, the SOP may only state a commitment to accuracy and indicate that study-specific guidelines are to be followed and methods documented at the study level. The data management plan is a good place to identify any study- specific exceptions or changes to the standard procedures.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ENTRY QUALITY", "definition": "As the saying goes, garbage in, garbage out. Data in the database is only as good as the collection method, so when data entry is used, it should be considered an essential step in assuring quality. Quality comes from using people and technology appropri- ately and efficiently. When using inexperienced or temporary help, encourage them Receiving Data on Paper 63 to think quality rather than speed. They are the first line of defense on identifying problems with the CRFs, the sites, the entry application, and sometimes the central database. When using technology, have it do what it is good at\u2014this usually means checking the data and may also include initial entry through OCR. In general, don\u2019t duplicate manual tasks with system tasks; find a way to make better use of both and apply the resources where they provide the most benefit. 65 7 Overseeing Data", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Tracking Challenges", "definition": "Tracking systems and their associated processes need to be able to manage a set of typical situations that arise with CRFs: \u2022 Repeating pages with the same page number \u2022 Pages with no data \u2022 Duplicate pages \u2022 Pages with no page number", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Repeating Pages", "definition": "In Chapter 2 we learned that whenever we don\u2019t know how many pages will be needed for a particular kind of data, repeating pages are used. These are pages such as those for concomitant medications or adverse events where the sponsor may not know how many copies are required to capture all the information obtained from each subject. Sometimes the CRF designer will guess an upper limit and repeat those pages\u2014each with its own page number (e.g., pages 140, 141, and 142 may all be adverse event [AE] pages). A more common design is to provide several identi- cal copies of the page with the same page number in the CRF binder and provide a blank repeat or sequence field for the page. The site fills in the blank with a number or letter such as: 140.0, 140.1, 140.2", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "or", "definition": "140, 140a, 140b The database design associated with page number fields often divides the page number into two fields: one that is the base page and another that is a sequence number, as in page = 140, sequence = 2. Whether it is one field or two, a CRF page 68 Practical Guide to Clinical Data Management, Third Edition tracking system would have to handle a base page 140 with multiple occurrences for a single subject. Given the goal of entering all of the data for all subjects, some companies prefer to have an indicator on these pages to mark the last page. The CRA or site will mark a last page box when collecting the final of a repeating set of CRF pages for a subject or closing down the site. Other companies trust the monitoring to ensure that all the data is collected. Note that asking sites to provide page of does not work well because it does not permit filled pages to be collected and entered while the study is ongoing since the site would not know the total number of pages at the time the first page is complete.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Pages with No Data", "definition": "Some pages in a CRF booklet will not have data to enter into the database. Some, such as pages designed to hold copies of specimen labels, are designed to have no data, but the sponsor does expect to receive them as part of the study. In other cases, a subject may miss an entire visit or the study design may call for alternate pages to be used in specific circumstances. In those examples, the site is frequently instructed to send in the empty pages or not-applicable pages with a line drawn through them and \u201cnot done\u201d or \u201cno data\u201d written on them. If pages are being tracked through initial data entry, repeated double-checking of why data from those pages is missing (because it has no data) can be avoided by tracking the pages as no data pages when they are received or when they arrive at first entry. (This would require a database field or cross-check with the tracking system.)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Duplicate Pages", "definition": "No matter how well designed the CRF or how carefully monitors instruct the sites, sites seem to find ways to send in duplicate pages for a subject. Some actual examples help illustrate what can happen: \u2022 The site notices they filled out a form incorrectly, but it was already col- lected. So they fill out a new one transcribing much of the data but correct- ing some of it and then send that in. \u2022 The site sends in a page marked as having no data and realizes they made a mistake, but the page has a line through it, so they fill out a new one. The monitor collects both. Ideally, the tracking system will identify duplicate (nonrepeating) pages when they are logged in. When problems are caught early in the process, they are usually much easier to fix. Unfortunately, not all tracking systems catch duplicates early and so it falls to data management and/or statistical reports to identify the problem further down the road. Once duplicate pages are identified, it is usually necessary to remove one of them from the system or correctly sequence them as versions. Studies without Page Numbers Historically, not all studies had page numbers on all the CRF pages. Some of these studies did not follow the typical structure where visits happen in a predefined Overseeing Data Collection 69 sequence ending with a termination page. Studies with repeated applications of a treatment or dosing cycles (possibly by the subject at home) are one example. In other cases, the CRF pages were not numbered to reduce the number of unique page templates needed for printing, which used to reduce the printing cost significantly. In some of those studies, a page template name identified the kind of page (e.g., Demog page, PE page, Lab page, and so forth) and the pages repeated in visits or cycles. In others, a unique document identifier was deemed sufficient to uniquely identify and track the page. With advances in printing and because of the convenience of page numbers, we see this much less frequently. In fact, most tracking systems require a page number. Should a CRF design arise without the normal page numbers, consider carefully how (if at all) CRFs can be tracked with existing tracking methods.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Automatic Checks", "definition": "Automatic checks to identify discrepancies are frequently called edit checks. In order to perform the same checks on all the data consistently throughout the course of the study, data management groups create a list of checks at the start of the study, often called an edit check specification. An edit check specification lists all the checks that will be programmed into the system and/or entry forms. (See Chapter 4 for further discussion of edit check specifications and an example.) Data manage- ment groups strive to program most edit checks because they are more reliable if they are automatic and the discrepancy is automatically logged or registered in the system. Of the automatic checks for a given protocol, perhaps 80% will fall into missing values, simple range check, and inconsistency detection categories, which can often be defined (programmed) by experienced data managers. The remaining checks would be considered more complex, and if they cross subjects, datasets, or pages, a programmer experienced with the underlying database and database programming language may need to define them. (See Chapter 4 for additional information on specifying automatic edit checks and Chapter 5 for programming and testing edit checks.)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Manual Queries", "definition": "Some manual review of subject data is considered standard practice for clinical tri- als. When review is performed manually it should be because the check is especially complex and requires human intelligence or programming externally. It should never duplicate automatic checks! At some companies, the kinds of manual review to be performed are added to the edit check specification. At other companies, there is a separate data review plan. These checks or reviews are usually small in number com- pared with the automatic edit checks but are often very important checks for medical review, data quality assessment, and compliance issues. Whatever the source of the manual discrepancy, it must be registered in the sys- tem so it can be tracked to resolution. In order to enforce careful checking and con- sistency, companies typically have data managers create the actual discrepancies no matter who identifies them. The data management group must be very careful to review all existing discrepancies associated with the same data before creating a manual discrepancy and sending it to the site as a query. Sites find it very annoying when they get two queries that ask them the same thing\u2014as might happen if two different people saw the same problem during different kinds of review or if a data manager did not review current discrepancies. Clinical and Listing Review One kind of manual review that does have high value and is very common practice is often called clinical review. Reviewers will cross-check adverse events against medications, check indicators of health being collected, and generally look for inconsistencies. A review of all text fields is a common part of medical review or is carried out separately. Data managers would not typically perform clinical or medi- cal review unless they have a medical background or training.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CLEANING DATA", "definition": "1. Use of edit checks 2. For paper: data management self-evident corrections (SECs) 3. Manual cleaning or review of data 4. Clinical review of data (if appropriate) 5. For paper studies: flow of queries including tracking 6. For EDC studies: process for reviewing and closing queries Associated document(s): Edit check spec, self-evident corrections (SEC, paper only) ELECTRONIC NON-CRF DATA 1. All sources of electronic data (e.g., interactive voice response (IVR) data, central labs, electronic patient diaries) 2. Frequency of load and format Appendix A: Data Management Plan Outline 237 3. Process steps, output: log of loads Associated document(s): File loading and/or transfer specifications; log of", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "tracked mail carrier", "definition": "\u2022 Monitors may carry them along for site visits \u2022 CDM staff or systems can fax the query to the sites \u2022 CDM staff or systems can send PDF versions by email to the site All of these are acceptable from a regulatory point of view as long as the queries are tracked (see following text) to ensure that queries sent and queries received back are not lost. Resolving Paper Queries The site receives the query forms, researches the questions, and provides resolutions on the query forms. The PI signs and dates each form, and the study coordinator files the forms in the subject binders at the site. Copies are sent back to data manage- ment using the appropriate method (see previous discussion) to data management for", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TRACKING QUERIES", "definition": "For both EDC and paper studies, data managers must track the status of discrepan- cies and queries throughout the study. By the time of study lock (see Chapter 13), all discrepancies and all queries must be resolved or otherwise closed. Data manage- ment is typically responsible for providing frequent updates to the study team on the total number of queries, unresolved queries, and how long it is taking sites to resolve queries. EDC systems typically have reports built in to provide query numbers by status and site, and can also identify queries that remain unresolved past a reasonable period of time (e.g., beyond three weeks). Tracking queries is more of a problem for paper for several reasons: \u2022 CDM systems may track individual queries, but they don\u2019t necessarily track the query form itself which can have multiple queries on it. \u2022 The paper query process has more stops in the workflow. \u2022 Data corrections found on the query form are a very important source of site data and are GCP essential records. The last point is very important: auditors have been known to ask sponsors to demonstrate that they have received all query forms from the sites and have applied all the corrections accurately. The goal then, for tracking paper query forms, is the same as that for CRFs: to make sure all query responses are received from the sites and that the corrections make their way accurately into the database. Similar to tracking paper CRFs, there is a tension between having lots of states for a query and having to manually update that status. Figure 8.2 shows how two", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "STORING LAB DATA", "definition": "When they set up database structures for a study, database designers also prepare the structures to store lab data and associated information. As we saw in Chapter 3, \u201cDatabase Design Considerations,\u201d database tables may be structured in a tall-skinny 88 Practical Guide to Clinical Data Management, Third Edition (normalized) or short-fat format. In the tall-skinny format, there are fewer columns, and data is collected in many rows. In the short-fat format, there is one column for each piece of data collected and one row per collection. Lab data lends itself particu- larly well to a tall-skinny format, despite the fact that it makes some kinds of queries and checks more complex. Advantages of the Tall-Skinny Format The reasons most companies prefer the tall-skinny format for lab data include: \u2022 The need to store information in addition to the actual test result \u2022 Ease of checking against normal ranges \u2022 The structure allows for flexibility in reporting and analysis \u2022 Loading routines for electronic files is simpler All these points are worth exploring in further detail. The need to store information in addition to the test result is probably the over- whelming reason to go with a tall-skinny format. One common CRF page design for collecting lab data has a single field next to the name of each lab test where someone from the site writes in the result, and next to that might be a box to indicate if the site finds this value to be clinically abnormal. There may even be a text field associ- ated with if abnormal. Besides the results and the abnormal indicators, lab results have further additional data associated with them, some of which are printed on the page and some of which are calculated or derived. Units are often preprinted on the page, yet they should always be stored with or linked to the data in the database (see following text). Derived or calculated data may include test values converted to stan- dard units. If a tall-skinny format is used to store the result, fields for abnormal, and then also units and a standardized result, this structure (a table or record) would have six columns; a short-fat format would have the number of columns equal to six times the number of tests. Figure 9.2 shows a tall-skinny lab table and a short-fat lab table for the case of the four lab results only (not including the context information). Normal ranges for laboratory values are nearly always stored in the tall-skinny format when they are collected (see following text). Checking routines that compare the test results against the normal range for that test are easiest to create when the", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WBC", "definition": "FIGURE 9.1 Examples of values generally called lab data. Note that some assays, such as white blood cell count (WBC), show up in more than one group. Be aware that these are not the same values. They measure different things and have different units.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Managing Lab Data", "definition": "95 way. Later, someone at the lab transcribes the result into Microsoft Excel or Access. Neither of these packages is a 21 CFR Part 11 compliant system if used as is out of the box and creating a compliant application based on them is a significant undertaking. If the lab does nothing more than enter the data into an electronic file, there is no security against inadvertent or intentional changes, no audit trail, no checks to assure accurate transcription\u2014indeed no guarantee of data security and integrity. A lab could use these off-the-shelf packages if they reliably verify 100% of the data and then immediately lock or store the files on read-only media (such as a CD) to prevent changes. While this is a simple approach, it does take a lot of discipline to satisfy the reliable part and the immediate part so that changes are not made after the data has been verified. It comes down to how good the procedures are and how likely laboratory staff are to follow those procedures consistently. The lab then ships the data to the sponsor who may run edit checks or other types of analyses on it. The edit checks are likely to identify some discrepancies in the data, so a process must be in place with the laboratory that details how corrections are to be made. Normal query forms may be the best approach here unless a large number of changes are expected. In that case, it may be more efficient to have the lab correct the original file (verified, of course, to detect inadvertent changes while editing) and resend. To make this work to produce reliable data entails significant investment in proce- dures and in manual review by both the lab and the sponsor. See Chapter 10, \u201cNon- CRF Data,\u201d which discusses handling of data in electronic files in detail, for more controls on electronic data.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PLATELETS", "definition": "PLATELETS_UNIT STD_PLATELETS FIGURE 9.2 Lab results with additional fields for units and standardized results stored in a tall-skinny format and a short-fat format. (Both kinds of tables would also have columns for header and patient identifying information, which are not shown.) 90 Practical Guide to Clinical Data Management, Third Edition the results column, this means that the expected characteristics of the data cannot be enforced. For example, it is not possible to put simple range checks on the results column of a tall-skinny lab table because it contains results from all kinds of tests. In fact, since the results for some tests are text (e.g., +2 for glucose measured in uri- nalysis), the column itself must be a text type. These characteristics also dictate that results cannot be coded. That is, test results that otherwise might be coded (such as platelet estimate: 1 = adequate/2 = inadequate), would have to be stored as simple values (such as: ADQ and INADQ). Another disadvantage of the tall-skinny format is the extra work introduced when writing checking routines, derivations, and queries. Each check must include the name of the test as part of the logic. That is, a range check on Hemoglobin in a short- fat format might read: hemoglobin >= 11.9 and hemoglobin =11.9 and test_result<=17.0). It may not look like much additional work, but over the many lab tests common to most studies, errors are bound to occur in checking routines, reports, and queries. Despite these significant disadvantages, the flexibility of the format seems to have led nearly all data management groups to store lab data in the tall-skinny format.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Identifying Lab Tests", "definition": "Whether the lab results are stored in the tall-skinny or the short-fat format, the tests must be identified. In the tall-skinny format, the name of the test (or a code for the name) appears as a data value in the \u201ctest name\u201d column. In the short-fat format, the name of the test is used to name a column onto itself. (Refer again to Figure 9.2.) In both cases, care must be taken to recognize the difference between similarly named results collected in different ways. For example, a test named Glucose appears both in blood chemistry tests and also in urinalysis tests\u2014and they are not the same. Similarly, it might be important to differentiate between values taken in fasting and nonfasting states. Naming the tests differently is the method usually used for assays that appear in more than one grouping of tests. The hematology version of white blood cell count (WBC) may be called HWBC and that for the urinalysis version may be called UWBC. Another approach is to store the groupings separately so that blood chemistry values are separate from hematology values, which are separate from urinalysis values\u2014in this case, simply using the name WBC may be adequate to fully identify the value. Storing the grouped values separately can be implemented in either tall- skinny or short-fat formats. Identifying the difference between conditions such as fasting and nonfasting for a test is more difficult. Naming would prove unwieldy, in particular for those studies", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Laboratory IDs", "definition": "Because normal ranges depend on the method and equipment used, there must be some way of knowing which results\u2014and which normal ranges\u2014come from which locations. Therefore, a laboratory ID of some kind must be associated with each result and also with each normal range. In some cases, the laboratory will be the same for all subjects in a study. More typically, several laboratories process samples for a single study. Because of the importance of knowing which ranges are associ- ated with which values, it is better not to make assumptions but rather to store the laboratory ID for each sample taken from each subject. For example, although an investigator nearly always uses a given lab, there may be an emergency that requires an alternate lab for a set of subjects or a period of time, or a lab may do 4 of 6 analy- ses but send out for the remaining 2 to be performed elsewhere.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Normal Range Storage", "definition": "Normal ranges may be stored in the same storage area as the clinical trial data, or they may be stored centrally and available to multiple studies. Storing the data cen- trally reduces the workload to enter and manage the values. However, care must be taken to allow checking programs and appropriate staff to access that central data. Also, if the study is archived or transferred, the associated normal ranges might need to be extracted for archive or transfer also. As noted earlier in this chapter, normal range data is usually stored using the tall-skinny format. In addition to the high and low range values for the result, the normals data must have the laboratory ID and the units used. If ranges are collected more than once per study or if the normal ranges are stored centrally, an effective date must in some way be available. If there is an age or sex dependence, there must also be columns for that. Figure 9.3 shows one example of a group of fields to store normal ranges in a tall-skinny format.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LAB RESULT TRENDS", "definition": "Both discrepancy checking and reporting on normal range values focus on a single, specific result. They do not detect when values have changed significantly from the baseline for a single subject nor do they identify trends for all or a subset of sub- jects in a study. This kind of cross-visit and cross-subject checking has traditionally been left to the statisticians to perform. However, in the interest of detecting prob- lems early, some data management groups have been given the task of reviewing the laboratory data before statisticians look at it using special tools and programs. While data managers typically do not have the training to make statistical or medi- cal assessments, they can detect patterns that have not been caught by simple range checks and bring them to the attention of the site or medical monitor.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USING CENTRAL LABS", "definition": "In multicenter trials, a central laboratory is frequently used to deal with the com- plex issues of quality control needed at every laboratory. GCP requires that all labs have full documentation, systems with data audit trials, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections. The sponsor must be assured that the GCP requirements for every lab in the study are met. Shipping samples to a central laboratory for large trials makes this management LAB_ID: Identifies the source of the normal range values EFFECTIVE_DATE: Date the range became effective TEST_NAME: Name of the lab test or analyte; must be consistent with that used in storing", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "patient results", "definition": "TEST_UNITS: Units that apply to the range values SEX: If present, the range is sex dependent AGE_LO: If present, the low end of the age range to which the normal values apply AGE_HI: If present, the high end of the age range to which the normal values apply NORMAL_LO: Low end of the normal range NORMAL_HI: High end of the normal range FIGURE 9.3 An example of a group of fields used to store normal range data in a tall- skinny format. Each field creates a column in the database table. This example assumes that at least some of the ranges will be sex and age dependent. 94 Practical Guide to Clinical Data Management, Third Edition more reasonable. It also reduces the variations in the normal ranges that would be expected if several labs were used. Of course, there are factors that should weigh in favor of the use of local labora- tories including: \u2022 Expertise in particular area, perhaps with an unusual assay \u2022 Need for very fast analysis due to medical need or for screening purposes \u2022 Problems with logistics or cost of sample transportation In a trial with a single or few sites, the local laboratory may well provide a conve- nient and cost-effective option. When a trial calls for use of one or more central laboratories, the data invari- ably comes in as an electronic file and not on the CRF or eCRF. The next chapter (Chapter 10, \u201cNon-CRF Data\u201d) discusses how data arriving electronically is managed and cleaned.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USING SPECIALTY LABS", "definition": "Many companies are developing drugs and devices on the cutting edge of science. This often means that the lab tests or assays they need to perform to determine the efficacy of the treatment are also on the cutting edge. When this is the case, the sponsor will sometimes need to turn to specialized laboratories to perform the tests. All too often, these are small labs or even investigator sites that are not set up with good practices, standard operating procedures (SOPs), and systems that are 21 CFR (Code of Federal Regulations) Part 11 compliant. The sponsor receives a shipment of data at the end of the study and quickly identifies a raft of problems or inconsistencies and then faces the question of how reliable and analyzable this data is. Must the study be rerun or can some other approach be taken to avoid throwing out the results of the trial? There are two important steps that sponsors can take proactively to help assure a level of confidence in the data: auditing the lab and set- ting up verification procedures.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Auditing the Lab", "definition": "The sponsor is ultimately responsible for data coming from a laboratory. When cen- tral labs are used, companies will typically audit the lab or will refer to a past, recent audit. For the most part, this is a cursory audit since large central laboratories are audited constantly and are likely to have reasonable practices and be in compliance with regulations. When a small laboratory or investigator site is needed for a study, the sponsor must audit much more carefully and pay particular attention to the com- puter systems that will be used for collection and storage of the data. There must be assurance that the data is reliable and reflects the actual results. In a very common scenario, the lab runs a specialized assay on a sample using some equipment they own or they follow an analysis procedure they have developed. The equipment is likely to be validated and reliable and it will often print out or dis- play a result. These results may be taped into a lab notebook or filed in some other", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "of studies", "definition": "\u2022 Pathogen identification in studies of infections \u2022 Interactive voice response system (IVRS) data for randomized trials \u2022 Pharmacokinetic (PK) data in early phase trials \u2022 Data from electronic patient report outcome devices These types of data are critical to the analysis of the study, and just like CRF data, they must be accurate and complete and the sponsor must be able to show that steps have been taken to ensure the integrity of the data. In this chapter we will discuss how non-CRF data is received and stored in compliance with regulations and how it is cleaned to show evidence of completeness and quality. RECEIVING ELECTRONIC FILES FROM A VENDOR Clinical data in electronic format is subject to 21 CFR (Code of Federal Regulations) Part 11 requirements since it will likely be used as part of a submission to the Food and Drug Administration (FDA). Sponsor and contract research organization (CRO) computer systems used for clinical data management must meet the requirements of the rule, and this is also true of any laboratory or vendor providing data associ- ated with a clinical trial. In Chapter 9 we saw the danger in small independent labs that may not be using Part 11\u2013compliant systems, but even when the lab or vendor systems are compliant, integrity and security must be maintained when the data is transferred to the sponsor or CRO and then moved through the data management processes for the trial.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Transferring Files", "definition": "Clinical data should not be sent by email without additional security. The federal regulation 21 CFR Part 11 considers email to be part of an open system and advises additional security such as encryption and password protection for data sent by 98 Practical Guide to Clinical Data Management, Third Edition email. The rule in Section 11.30 says, \u201cPersons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and con- trols designed to ensure the authenticity, integrity, and, as appropriate, the confi- dentiality of electronic records from the point of their creation to the point of their receipt\u201d (emphasis added). At a minimum, the sender should use a zip utility and password-encrypt the file to prevent unauthorized decompression. The password should never be sent in the same email as the file; ideally, it is agreed upon prior to the transfer or set separately for each transfer and communicated by phone. Other secure methods of transmitting clinical data include sending CDs by tracked carrier, using secure drop boxes reached electronically, and giving the vendor access to the appropriate secure closed networks of the sponsor or CRO. Once the data is received, it must also be stored securely in such a way as to be able to provide evidence that the data received from the vendor was not purposely or inadvertently modified without audit trail. Many companies load vendor data into a clinical data management (CDM) database or other data warehouse to provide such assurance. Other options include creating secure read-only areas on servers to provide the gold copy of the data. (Gold copy or golden master refers to the original release or shipped copy of software or data.) Any later use of the data could then be compared to the original to show that it had not been altered.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Formatting the Data", "definition": "We talk about sending data from the vendor to the sponsor or CRO as an electronic file\u2014but what kind of file is it? Is it Microsoft Word or Excel? Is it an SAS\u00ae transfer file? Is it a simple ASCII, comma-delimited format? What data is in the file? How are the subjects and samples identified? Because the vendor needs to know what to send and the receiver needs to know what is coming in, it has become industry standard practice to establish file transfer agreements. These agreements specify the format and content of a transfer and usually also identify the frequency and method of trans- fer. Both the vendor and the receiver should approve the document.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Loading Data", "definition": "Loading non-CRF data into a central CDM or warehouse database is done either through programs written specifically for each study or by configuring a utility within the system. As noted in previous chapters, whether users write a program or configure an application, if it affects clinical data, it should be subject to a validation process. In addition, whenever clinical data is copied or transferred, it is subject to 21 CFR Part 11 and loading would be considered a copy. The validation process for any application starts with a specification. A map- ping of the layout of the electronic file as described in the file transfer agree- ment to the database storage structures provides the basis of the specification. The specification will also have to address data issues as described in the following text. The validation continues with the program being written according to good company practices or the application being configured according to guidelines and manuals. Documented testing, release, and specific user instructions round out", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Non-CRF Data", "definition": "101 and the question will be whether the data was not transferred or never available. So, the one field that should appear on the CRF to match lab data is an indicator to be marked if for some reason the sample was not done or is in some way not analyzable. Companies that drop those fields in large Phase III trials with a significant amount of external data will find a very large number of reconciliation queries to the site when there are missing records in the vendor data but no way to know if the vendor missed something or the site did not perform that test. As the previous example implies, any questions about differences in expected data and received data could be due either to problems at the vendor or to problems at the site. Typically, inquiries to the vendor are informal, such as email or shared spreadsheets to track discrepancies. If the vendor confirms everything is correct to their knowledge, then the site must be queried via creation of a manual query (see Chapter 8). QUALITY ASSURANCE FOR EXTERNAL DATA Data from a vendor must be transferred and stored according to the requirements of 21 CFR Part 11. If a company does nothing else with electronic data received from a vendor, it must still ensure the integrity of the data received. This requirement can- not be overstated and should never be overlooked. The completeness of the data might be considered part of data integrity, but the steps to ensure it are also steps that provide confidence in the data\u2019s quality. Data reconciliation as previously described is used to ensure that the company receives all the expected data and also no extra unexpected records. Data reconciliation against fields on the CRF or eCRF provides confidence that the data reported for a given subject and sample or reading is in fact the right sample for that sample or reading; that is, no samples have been inappropriately assigned to another subject.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs FOR NON-CRF DATA", "definition": "Because transfer and copying of clinical data has to meet 21 CFR Part 11, a stan- dard operating procedure (SOP) should be in place to show that procedures used for receiving and loading electronic files from external vendors are in compliance with the rule. This SOP should either require transfer via a closed system or require that extra security is in place if the open Internet or email is used. That electronic file transfer SOP, or a separate SOP on data loading, should also require a transfer specification for every type of data and vendor. The transfer specification will act as the specification against which test transfers and loads will take place. Initial configuration and programming of loading programs must be tested to show that the data is not altered during the load (copy). It is also wise to require some kind of review or check of an error log for every transfer even when the receipt of data becomes routine during the conduct of the study because nearly all companies have had the experience of receiving files from a vendor without problems for a period of time and then having the vendor inexplicably change the data format. Finally, a study cannot be locked (see Chapter 13) until all the external data has been pro- cessed and reconciled. 102 Practical Guide to Clinical Data Management, Third Edition WHEN NON-CRF DATA IS OUTSIDE DATA MANAGEMENT At some companies, non-CRF data becomes the responsibility of groups outside of data management. For example, if the external data is being sent as SAS datasets, the results may go directly to the SAS programmers. If this is the case, the data man- agement plan or other company data handling agreement should make clear who is responsible for the reconciliation of the data against CRF data and how any discrep- ancies found in that reconciliation are to be handled. Even though data management is responsible for the completeness and accuracy of the data, this situation may make it impossible for data management to carry out tasks because they do not have access to SAS or SAS dataset storage folders. There is a danger here that no accounting and reconciliation happens in this case. There is another danger that other groups may not be as aware as data management of 21 CFR Part 11 requirements for transfer and storage. To avoid data problems, data management must take the lead in bringing these matters up to the study team for the good of the trials. 103 11 Collecting Adverse", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Adverse Event Forms", "definition": "AE forms will collect several kinds of data, including the following: \u2022 The text used to describe the event \u2022 Start dates (and possibly times) \u2022 Stop dates (and possibly times) or an indicator that the event is continuing \u2022 A variety of indicators including severity, relationship to drug, outcome,", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and action taken", "definition": "\u2022 Additional comments or additional treatment or medication information It is very common to have the AE form include a question that asks: Is this a seri- ous adverse event? This is the trigger that lets clinical data management know that SAE reconciliation, as described in the following text, will be required. The example AE form in Figure 11.1 shows typical fields. For all studies, the investigator will ask the subject about any adverse events since the last visit or check point. For some studies, companies will transcribe these events Collecting Adverse Event Data 105 Protocol N013_06 Site: \u25a1 \u25a1 \u25a1 \u25a1 Subject: \u25a1 \u25a1 \u25a1 \u25a1 Page 121. Where any AEs reported from the time of study drug administration to final discharge from the study? Yes \u25a1 No \u25a1", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "if SAE", "definition": "1 \u25a1 2 \u25a1 3 \u25a1 Relationship to Study Drug 1 \u2013 Probably/Possibly Related 2 \u2013 Not Related", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Intensity", "definition": "1 \u2013 Mild 2 \u2013 Moderate 3 \u2013 Severe Action Taken with Study", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Med", "definition": "1 \u2013 None 2 \u2013 Interrupted 3 \u2013 Discontinued", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "such as in onset date", "definition": "See Chapter 11, \u201cCollecting Adverse Event Data,\u201d for further discussion of SAEs and the reconciliation process. Another common source of duplicate storage occurs when a trial uses an interac- tive voice response system (IVRS) to randomize the subject or assign a treatment via a kit number. The IVRS will store responses and the assigned treatment group in its database system, and the CRF or eCRF design may also require that the assignment be recorded so it is also stored in the clinical database. Reconciliation between the CRF and the IVR system is a very good idea\u2014in a trial of any size, expect that some of the information will not match. In fact, it is very important to know if the IVRS assigned one kit number but the site provided a subject with a different kit number (for whatever reason). Companies have also found themselves reconciling against paper in cases where sites are asked to provide additional information to the medical monitor for adverse events being reported more frequently than expected. That is, when the medical", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs FOR AE DATA", "definition": "Good process for managing safety data cannot be emphasized enough. Normal data management SOPs will cover most activities except SAE reconciliation and AE/SAE coding. SAE reconciliation involves the safety group, the medical monitor, and clini- cal operations in addition to data management, so SAE reconciliation SOPs should be coordinated and signed-off by every group involved in the process. The proce- dures should clearly spell out responsibilities for the steps in SAE reconciliation, including providing database listings, safety systems listings, discrepancy reports, site queries, and data updates to both systems. Traditionally, reconciliation has only been done after all the data has been col- lected, before study lock. As we see a higher expectation that companies be aware of possible safety problems with their treatments, most companies are going toward more frequent, even monthly, SAE reconciliation for Phase II and III studies, with final reconciliation again at study lock. The sheer volume of SAE reports from a Phase III study with seriously ill subjects will necessitate processing them through- out the course of a trial in order to keep up, but a Phase I trial may have no SAEs at all. No matter when reconciliation takes place, evidence of the reconciliation must be in the data management or clinical files. Ideally, a medical monitor signs off on the final reconciliation prior to lock, if not the intermediate ones. The data manage- ment plan is often the place where the frequency of reconciliation is recorded for a given study. The SOPs and guidelines governing coding will be presented in Chapter 26. If coding is performed by different groups in the two systems (clinical and safety), then it might be necessary to have two SOPs. IMPACT OF AEs ON DATA MANAGEMENT While adverse event data is, in many ways, like any other data collected during a clinical trial, it is critical to the evaluation of the safety and efficacy of the treatment. In particular, adverse events add coding of reported terms and reconciling of serious adverse events to the data management process of a study. Both of these tasks tend to be particularly active as close of the study nears. Reconciling, in particular, may not be possible earlier in the course of the study, and even if performed earlier, will have to be repeated at the end of the study. The effect then, of adverse event data as a whole, can be to impact the close of a study. Data managers may not be able to change this, but they can be aware of it and plan for it. When sign-off on coding and SAE reconciliation is required to lock a study, data management must notify the medical monitor or responsible party that his or her attention will be required in order to avoid surprises and/or delays in lock. 113 12 Creating Reports and", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DATA TRANSFERS", "definition": "Transfers of data are different from reports in that the data is copied and sent else- where (either within or external to the company) to be analyzed, reviewed, and reported on. Transfers of data nearly always involve or include some safety and efficacy data. Because of this, data transfers should be guided by the requirements of 21 CFR (Code of Federal Regulations) Part 11 for validation of software and for verified copies. There are two elements to ensuring accurate transfers. The first is to create the extract program that pulls the data out of whatever database it resides in and puts it, perhaps with some reformatting, into a target file. This extract program or script must be validated to show that it works properly and that it creates an accurate copy during testing. The second element of transfer is the sending of the resulting file or files. The copy of the data is made into a target file or files that are then transmitted to some receiver. In addition to requiring evidence that the copy is accurate, 21 CFR Part 11 requires extra security if the data goes into an open system such as the Internet via email. (See Chapter 10 for further discussion of sending and receiving data by electronic files.) Two techniques for ensuring accu- rate copies and secure transfers are the use of transfer checklists and the creation of transfer metrics.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Transfer Checklists", "definition": "Even if the transfer is a one-time occurrence, a checklist of the steps needed to produce it helps assure that nothing is overlooked. If the transfer is repeated dur- ing the course of a study or studies, the checklist is essential to assure consistency and completeness at each transfer. The checklist should be created before the very first transfer, even if all the steps are not known until a few test runs have been completed: the act of documenting before doing helps point out undefined areas and allows cross-checks to be built in from the start. Figure 12.1 illustrates the steps that might be in a checklist for transfer from a computer to a CD. Because a CD is used in the example, the compressed files are not password protected. Files sent via email would need to be protected or encrypted. In this particular checklist, the person overseeing the transfer manually creates a trans- fer file and copies in the data metrics (see text that follows). A much better approach Creating Reports and Transferring Data 117 would be to have the extraction programs or scripts create all or nearly all of the information required for the transfer. Just creating the checklist as a tip sheet is usually not enough to make sure all the steps are followed. Even the most conscientious data manager may overlook a step. Guidelines that require printing out the checklist and initialing each step on comple- tion usually help ensure that all steps are followed. The checklist provides excellent documentation for the transfer and can be filed with a copy of the transferred data.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Transfer Metrics", "definition": "Transfer metrics are numbers that help verify that the data was completely extracted to the transfer file(s). Exactly which metrics will be useful for any given transfer will depend on the format and number of the transfer files and on the type of data being transferred. Some of the common transfer metrics include: \u2022 Number of files \u2022 File sizes \u2022 Number of subjects per file \u2022 Number of records per subject \u2022 Number of records per table or file Some companies also create a checksum (a number generated by an algorithm that is unique to the contents of the file) for each file. Checksums can help detect corruption of the contents of the file. Data managers review these metrics once the transfer files have been created to get a sense of whether the transfer program put the correct data in the file. This is use- ful even if the data manager does not know exactly how many subjects or records to", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study Closeout", "definition": "As the date for the last subject visit\u2014most commonly referred to as last patient out (LPO) or last patient last visit (LPLV)\u2014approaches, study closeout activities begin. Study closeout includes final cleaning and review of data. When the data is deemed clean and complete enough for analysis, the database records are locked against any changes. Database lock is the trigger for the data to be unblinded and extracted for analysis. After the database lock, additional activities complete the study closeout. For electronic data capture (EDC) studies, one of the most important activities is to create and distribute copies of the electronic case report forms (eCRFs) to the sites and to prepare a version for inclusion in the trial master file. 123 13 Study Database Lock As the last subjects near their final visit, the race to close and lock the study begins. Locking means that no data will be changed; a locked database defines the point at which final analysis can start and conclusions can be drawn. Because there is usu- ally high pressure to make those analyses (and related decisions) as soon as possible, companies frequently keep track of the time to database lock as a corporate metric and work constantly to minimize that time. The pressure to quickly lock a database for analysis comes up against a long list of time-consuming tasks that need to be per- formed first. The list includes many individual steps, including: collecting the final data, resolving outstanding queries, and performing final quality control checks. In this chapter we will look at the most common steps performed in preparation for study database lock in both paper-based and electronic data capture (EDC) stud- ies and address some ways in which the time to study lock can be reduced. The next chapter discusses activities that happen after the database is locked and touches on what needs to be done if a data change is needed after lock.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FINAL DATA", "definition": "Before a study can be locked, all the clinical data generated by the study must be present. The data, first and foremost, is the original data from the subject reported on case report forms (CRFs) or through electronic CRFs (eCRFs), but there is other data as well: corrections from the sites, calculated values, codes for reported terms, data from central labs, and any other clinical data from external reading centers. Any of this final data may generate discrepancies that will require resolution before study lock. To account for all the original data, data management uses tracking information to ensure that all expected CRF or eCRF data has been received; there should be no missing pages in a paper study or empty forms in an eCRF study. In addition, the data manager or lab data administrator checks that all central laboratory data was received and that any other electronic loads are complete. Once in the central data- base, this data will go through the cleaning process, which may generate discrepan- cies. (See also Chapter 10, \u201cNon-CRF Data.\u201d) As the final data comes in, the final calculated values also must be derived. Discrepancies raised by calculated values are usually traced back to problems with the reported data and may have to go back to the site. All reported terms (such as adverse events and medications) must be coded and any changes to terms that come in as corrections must also be rerun through the cod- ing process. When a term cannot be coded, a query may have to be sent to the site, but close to study lock, some companies will permit a medical monitor or clinical research associate (CRA) to make limited corrections to reported terms to allow 124 Practical Guide to Clinical Data Management, Third Edition them to be coded. Just to be sure everything is in a final, coded state, many compa- nies rerun coding over the entire set to catch cases where the assigned code changed due to a change in the dictionary or synonyms table and cases where the term was changed but the code did not receive an update (see Chapter 26 for more information on the coding process).", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FINAL QUERIES", "definition": "Resolutions for new discrepancies identified as final data is collected, as well as those queries and discrepancies still outstanding from earlier in the study are also required for completeness of the data. Generally, all outstanding queries must have a resolution before a study can be locked\u2014even if the resolution indicates that a value is not and never will be available. Getting these last resolutions and the required investigator signatures from the site can hold up the entire closure process, so CRAs frequently get involved in calling or visiting the sites to speed corrections. Because of the difficulties and time pressures at the end of the study, companies may choose not to pursue noncritical values at this stage of the data handling. Ideally, the list of critical values will have been identified at the start of the study in the protocol or data management plan and can be referred to when faced with getting a resolution from an uncooperative site right before study lock. Some companies call the point at which the last CRF data comes in from the site soft lock or freeze, but most companies wait until the last query resolution is in to declare a soft lock. In either case, this is the point at which the real work of assuring quality begins. The data is not locked yet because there may still be changes that come out of the quality activities, such as database audits for paper studies or final data review for any study, but the number of changes is expected to be small. The data is in a near-final state.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FINAL QUALITY CONTROL", "definition": "The quality of the data will affect the quality of the analyses performed on the data. At the close of the study, there is a particularly strong emphasis on checking the quality of the data that is about to be handed over to a biostatistics group. Because there is, or should be, a high barrier to getting a study unlocked, it is worth making an effort to check the data thoroughly. All kinds of review of the data help provide assurance as to its quality and correctness, but study closure checklists frequently include these specific kinds of checks: \u2022 Audits of the database \u2022 Summary reviews of the data \u2022 Reconciliation against other systems", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Database Audits", "definition": "Data transcribed from a paper CRF or other source into the database is usually checked for accuracy through a database audit. Data managers compare data in the", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Summary Review", "definition": "There are certain kinds of cleaning or discrepancy checks that are better performed near the close of a study when the data is more complete. These include listing reviews, summary reports, and simple analyses of the data as a whole. The goal of these reviews is to detect unusual values that stand out in the context of a full set of data but that might otherwise pass cleaning rules or other discrepancy identification methods. A listing review of text fields is a good example of how trained humans pick up inconsistencies that cannot be programmed into edit checks. In paper studies, data managers may review listings of text fields to check for nonsensical words that are introduced because entry operators are focusing on what they see rather than the meaning of a phrase. For both paper and EDC studies, a separate listing review by CRAs is often required for study lock. The CRAs may notice nonsensical phrases, but more importantly, they may find problems with protocol compliance. For exam- ple, they may review medications and find some listed that are not permitted by the protocol. Or, they may find medications listed in the medical history section. They may even find serious safety problems listed in comments associated with lab results or in adverse event reports. Humans are very good at detecting patterns or unusual values. Listing reviews of numeric values may also work for smaller studies to detect unusual values or outliers. For large studies, summary reports created from ad hoc queries or simple statistics performed on the data can identify unusual patterns or outliers by looking at the following: \u2022 Number of records or values per subject 126 Practical Guide to Clinical Data Management, Third Edition \u2022 Highest, lowest, and mean for numeric values \u2022 Distribution of values for coded fields (e.g., how many of each code) \u2022 Amount of missing data These summary reviews can be run by data management staff, but in some com- panies, clinical programmers will look at the data using SAS\u00ae. Graphs of lab and efficacy data or other simple displays or analyses can also identify possible problems with units, decimal places, and different methods of data collection that might not otherwise be caught by simple cleaning checks. These graphs and list- ings will probably come out of the programming or statistical group. In the end, the best review of the data is to run the planned analysis programs on the data even before it is locked. The goal is to have no surprises when the final programs run!", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Reconciling", "definition": "In the best case, clinical data is stored in a single location and extracted for review or analysis from one location. However, in the setting of a drug or device trial, it is not unusual for some data to be stored in more than one location\u2014and for very good reasons. When this is true, reconciliation may be necessary to assure consistency between the systems. The most common reconciliation with external systems is for serious adverse events (SAEs). Data on SAEs is typically stored in both the clinical data management system and also in a separate SAE system. When reconciling at study close, data management staff look for the following: \u2022 Cases found in the SAE system but not in the clinical data management (CDM) system \u2022 Events found in the CDM system but not in the SAE system \u2022 Deaths reported in one but not the other\u2014perhaps because of updates to", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "the SAE report", "definition": "\u2022 Instances where the basic data matched up but where there are differences,", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FINAL STEPS FOR EDC", "definition": "In a paper study, a clinical research associate (CRA) visits the site, checks the paper CRF against source documents, and then gets the separated pages to the data entry center. So, by definition, if the data is in the database, it has been monitored. In an EDC trial, the data is in the database right away, but it helps to know whether or not it has been monitored in order to judge how accurate it is. Most EDC systems build in a feature that allows the CRA to mark data that has undergone source document verification (SDV). Before database lock, all the data listed in the monitoring plan as requiring SDV must be marked as having undergone SDV. The CRAs can keep an eye on this throughout the study, but a final check prior to lock is still required. All EDC systems require that the investigators sign for the data according to 21 CFR (Code of Federal Regulations) Part 11 compliant features. The study is not final until the principal investigator has signed for all of the data. It is important to understand that when a discrepancy is discovered during study closeout activities, and it is added as a query, a change to the data by the site will \u201cbreak\u201d the investiga- tor signature. (In paper studies, the investigator just signs the query form to indicate knowledge of the data change.) The investigator has to re-sign. Because of this, all EDC studies need a check for investigator signature prior to locking. (See Chapter 8 for more information on principal investigator signatures in EDC studies.) USING A CHECKLIST TO LOCK A STUDY The final data collection and final cleaning steps are all critical to ensuring the qual- ity of the data. A checklist of procedures that must be completed prior to database lock is a standard tool in data management organizations. Generic checklists can be easily applied across studies and even across companies (see Figures 13.1 and 13.2 for examples); the more specific the list, the more valuable it is. If the database sys- tem or integrations with the database impose a certain order on the closeout proce- dures, reflect that in the database lock checklist. Such a checklist can be included as an attachment or appendix to the standard operation procedure (SOP) for study lock. Consider allowing the checklist to be modified to include study-specific elements such as sample data for a specialized substudy. Checklists work better when they require action by the user; just printing a list of steps to be completed prior to lock is not as effective as requiring a data manager to initial and date each step. (The date also provides useful information on the time required to complete each step, which can be used in planning future locks.) Most 128 Practical Guide to Clinical Data Management, Third Edition", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "All CRFs received", "definition": "All CRFs entered and verified All external data received All external data reconciled", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "All data coded", "definition": "Coding reviewed and approved SAEs reconciled and approved All queries resolved or closed Site permissions set to read only Approval to lock obtained All records marked as locked", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Initial and Date", "definition": "Sites have filled in all necessary forms SDV marked as per study requirements All PI signatures present All external data received All external data reconciled", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Request site PDFsa", "definition": "a See Chapter 14 for discussion of postlock activities for EDC. FIGURE 13.2 An example of a generic CDM lock checklist for an EDC study. A study- specific version of a lock checklist would list all the sources of external data individually or add steps to disable specific integrations being used to transfer data.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "COMPLETE STUDY FILES", "definition": "The lock of a database is such an important milestone in a study that staff will push hard to meet the deadline and then breathe a sign of relief because the bulk of the work is done. Before everyone moves on to new projects and forgets details, data managers should allocate time to make sure the study documentation is complete, submit items to the trial master file, and record feedback from the study. Most data management groups try to keep the data management study file reason- ably current, but it is a very good idea to have a study file audit shortly after lock. The lead data manager should check files to ensure that all required materials and documents are present. Documents should be the most recent version (or all versions, if required by SOP) and have current signatures if required. If being stored, the list of who worked on a study and what they did should reflect the final status. This is also a good time to add notes to file to record any unusual circumstances or data issues related to the study. Some of the documents created as part of clinical data management need to be submitted to the trial master file (TMF).* For example, the data management plan is now a standard element in the TMF and many companies consider study validation documents to be good clinical practice (GCP) records (see also Chapter 5). Other documents that support clinical data management (CDM) activities, such as final tracking reports, may be filed in offsite or online storage for some number of years without attempting to permanently archive them. A postlock step to complete filing will ensure that the documents are available later should they be needed.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ASSESS STUDY CONDUCT", "definition": "Very few companies schedule feedback meetings after a study lock. Unfortunately, people forget details and problems pretty quickly as they move on to new studies and so these problems are repeated in future studies. Right after lock is a great time to review the CRF or eCRF for fields that caused an unusual amount of trouble. Those * The trial master file is a file maintained by the sponsor that contains the essential documents associ- ated with the trial. Many of the required documents are specifically called out in ICH E6 GCP Section 8 (GCP), but others, such as the data management plan, are more of an industry standard. 134 Practical Guide to Clinical Data Management, Third Edition fields or modules should be modified if possible, not just reused for the next study. Similarly, edit checks that did not provide the results expected should be examined. This is also a good time to review the metrics from the study such as: \u2022 Total number of manual discrepancies \u2022 The percentage of discrepancies resolved in-house for paper studies \u2022 The top ten types of queries \u2022 Average time to resolve queries \u2022 Time from last query received to study lock The more information a data management group has from a past study, the more accurately the forecasts and estimates for the next study will be.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SITE ECRF COPIES", "definition": "Section 4 of ICH E6 GCP requires that sites have a permanent copy of subject records after the study has closed for at least two years after the last marketing application or discontinuation of clinical development. EDC applications allow sites access to eCRF data until study closeout, but at some point the application needs to be shut down or be moved off a production server. At that point, the site will need access to archival copies of the eCRF data. Some companies print copies of eCRFs populated with subject data, but the more current process involves creating PDF files with audit trail records and sending those to sites on CDs. Sites are instructed to check that the disc is correct and readable and to file that disc per site standard operating and archiving procedures. Sites should be asked to return a confirmation form so that the sponsor has a record that its obligations have been met.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "UNLOCKING", "definition": "Once the study is locked and analysis begins, it is not uncommon to find problems with the data that require corrections. (This is particularly true if final quality control does not include the summary reviews of the data or draft runs of the analysis pro- grams as we discussed in the previous chapter.) New information regarding adverse event data found during site closeout or site audits may also require updates or addi- tions to the data. Because database lock triggers a cascade of other activities, unlock- ing the database has a serious impact in that many or all of the postlock activities will have to be rerun. Also, while the Food and Drug Administration (FDA) seems to accept an unlock here or there as being normal, if multiple unlocks of a critical study come to their attention, they will question the quality of the data. Unlocking, then, is a serious matter that should first be avoided by good locking practices, and if unavoid- able, unlock must be approved at a high level and conducted with care.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Avoiding Unlocks", "definition": "If, after a lock, data analysis or site closeout procedures identify data that is incor- rect, it is not always necessary to unlock the database and make the correction there.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "QUALITY ASSURANCE", "definition": "Study file audits after study lock are a quality process that ensures all the required documents are present and filed with the TMF or in other central records storage. Study feedback sessions close the loop and provide feedback that will actually enhance quality of trial conduct over time. Good lock practices will reduce the need to unlock study databases and so avoid the difficulties and resources associated with the unlock process. SOPs FOR STUDY DATABASE UNLOCK As noted in the previous chapter on lock, the procedures for unlocking a study may be combined with lock procedures in a single standard operating procedure (SOP) or may be split into a stand-alone SOP. Standard procedures for unlock should require a high-level approval prior to opening the database to changes. Those procedures should also specify that the unlock form, the relock form, and all evidence to show that the unlock updates were appropriately limited, should be filed in the data man- agement study files.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AVOID UNLOCKS", "definition": "Unlocks should be few and far between. Good lock practices are needed to keep the number of unlocks to a minimum\u2014but those practices should be put into place not just in clinical data management but also in clinical operations and biostatistics. Clinical data management focuses efforts on completeness and quality of the data, but that is not enough. Good practice and training in clinical operations will help ensure that monitoring is thorough to avoid missed safety or medication data. Biostatistics plays a role by being involved in defining required data cleaning and quality checks and by reviewing data using planned analysis programs prior to lock.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs ON SOPs", "definition": "Yes, there should be an SOP on SOPs! This procedure is usually developed at the corporate level and typically would contain references to the required sections of an Standard Operating Procedures (SOPs) 147 SOP or point to a company template. Ideally, the SOP on SOPs would also give some guidance as to what processes are documented in SOPs as opposed to in guidelines or work instructions. Many SOPs on SOPs do not include the process for approval and how to determine the needed signatures. This is unfortunate as it can result in inconsistencies on approvals for SOPs developed by different groups. There will always be cases where the process cannot or was not followed, so the SOP on SOPs must also include a process to follow for deviations and prospective waivers. Finally, the SOP should require review of each SOP within a period of time (typically on the order of two years) from the time it becomes active\u2014which leads us to the next topic: work on any given SOP must always be considered to be ongoing.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Role", "definition": "1. SOPs on: 2. CDM System 3. Guidelines Test Required?", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "First Pass Entry", "definition": "\u2022 CRF Workflow \u2022 Data Entry", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Entry Menu", "definition": "\u201cHandling Pages with No Identifier\u201d \u201cData Entry Guidelines\u201d", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Second Pass Entry", "definition": "\u2022 CRF Workflow \u2022 Data Entry", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Verification Features", "definition": "\u201cHandling Pages with No Identifier\u201d \u201cData Entry Guidelines\u201d", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Discrepancy Menu", "definition": "\u201cDiscrepancy Management\u201d No, work review only", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRF Designer", "definition": "\u2022 Designing CRFs N/A \u201cManaging CRF Files\u201d No, work review", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "only", "definition": "FIGURE 16.1 An example of a training matrix for conducting paper-based studies. The roles identify the kinds of tasks being performed. The columns list the different kinds of training from three different areas. The final column indicates whether a formal test is required to qualify to do the work on an actual study. 152 Practical Guide to Clinical Data Management, Third Edition training has been completed. (How to document this training is discussed in a fol- lowing section.)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HOW TO TRAIN", "definition": "Only large companies have training groups, and even then those groups often focus on companywide training. They may train on corporate SOPs, good clinical practice (GCP) in general, and other topics that pertain to groups beyond data management. If a data management group is large enough and lucky enough, they may have a data management trainer or CDM training group knowledgeable in data management and the systems used, but it is extremely common for data management staff to be responsible for training its own staff on top of other duties and expectations. In the latter case, it may be necessary to make it a yearly goal for some data managers to provide such training support and to recognize those who do it well. If a data management group is relatively small with low turnover, one-on-one training may be the most efficient approach. While many small groups assign new staff members to a buddy or mentor for training, this has been found to lead to wide variability in the quality of training. Ideally, one person in the group who is both interested in and good at training will be the designated trainer. If the group is grow- ing, periodic formal training sessions may become worthwhile. In this case, the qual- ity of the training will probably improve and be more consistent, but there are always issues about holding the classes when they are needed. Computer-based training may", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FIGURE 16.2\u2003 An example of the first part of a training matrix for EDC studies, with the list", "definition": "of all training components in the first column. Training components include courses (which may be computer-based or live), SOPs, and guidelines. The columns give the role, but in this case, the role is similar to a title but indicates what kinds of activities the employee is expected to perform. The full matrix would include all key data management roles and man- agers as well.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Training", "definition": "153 provide the consistency of training found lacking in mentor-based training, support part-time trainers, and make courses available as they are needed.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs ON TRAINING", "definition": "Not all companies have SOPs on training, but they do usually have very specific instructions on maintaining training documentation. If no company policy is in place, each data management group can set up a practice of having training plans for new employees. The training plan can cover the three areas of training: SOPs, department guidelines, and system training as recommended in this chapter. Study- specific training can be enforced through data management plans or requirements for the study files. ALLOTTING TIME FOR TRAINING Probably the biggest mistake smaller companies make is not allotting time for train- ing. They specifically hire experienced people and then expect each person to jump in and begin work. After all, that person has done this work before. That person may have done the work before, and they may even have used the same clinical data man- agement or EDC system, but they have not done the work at the company in question. As we saw in the earlier chapters of this book, there are many options for performing clinical data management and for using clinical data management systems. Each person needs to understand how the task is to be performed in each group\u2019s unique combination of procedures and system configuration. This takes time and may mean the new hire sits around a bit while waiting for training or review of work. But it is well worth the investment for all involved. State up front to each new hire (and the group that person joins) that new staff members should not expect to do production work for the first week or two (or even more). When the expectation is clear, no one will feel the new person is wasting time. 155 17 Controlling Access", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and Security", "definition": "The Food and Drug Administration (FDA) is very concerned, and rightly so, about the quality and integrity of data associated with clinical trials. In 21 CFR (Code of Federal Regulations) Part 11 and in guidance documents the agency frequently repeats the phrase \u201cauthenticity, integrity, and confidentiality of electronic records\u201d to emphasize their interest. The regulation is clear; Section 11.10 requires controls and procedures including: \u201c(d) Limiting system access to authorized individuals\u201d and \u201c(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.\u201d Limiting access (who can get in) is achieved through proper account management. Authority checks (who can do what) are set up via access control or access rights. Account management deals with assigning and maintaining usernames and passwords\u2014or bio- metric identifiers. Access control defines how those users are given access to particular features of the clinical data management system or electronic data capture (EDC) appli- cation and how and when that access is revoked. Good account management and access control has to be achieved through a combination of the features of the software being used and procedures to make sure the features are used properly and to fill in gaps in the systems\u2019 abilities. While clinical data management (CDM) staff does not usually create accounts for sites in EDC systems, they are commonly responsible for assign- ing accounts in classic clinical data management systems and, in either case, need to understand good practices around assigning and managing accounts.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ACCOUNT MANAGEMENT", "definition": "Accounts that are used to access clinical data management systems provide the user with varying degrees of power, or control, over data stored in the system. When the account permits the user to enter, modify, or delete data in electronic records, the username and password together constitute one kind of electronic signature. It is not the kind of signature that is the equivalent of a handwritten signature (such as the principal investigator signature for electronic case report forms (eCRF) in EDC) but rather is the kind of signature that makes the change to the data attributable to a par- ticular person. All data management systems automatically associate the person who is responsible for the entry or change with the data usually through the username. By thinking of the username and password as the way to make actions on the data attributable, it is easier to put procedures into place that govern the username and password in compliance with 21 CFR Part 11. The username must uniquely define a person and the combination of username and password constitute a signature. 156 Practical Guide to Clinical Data Management, Third Edition", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Usernames", "definition": "The statement \u201cusernames must uniquely identify a person\u201d sounds simple enough and most data management and EDC systems enforce unique account names, but there are some important, real-life cases to consider. For example, if the username associated with a common actual name (e.g., jsmith for Julia Smith) is removed when that person leaves the group or the company, then the possibility exists that that account name would be reused sometime in the future (e.g., when John Smith joins the group). In reviewing the data at a later time, it would then not be possible to immediately tell which person entered a particular record without referring to dates of employment and dates the record was created. It is best, therefore, to leave all account names in the system to prevent their reuse. When a person leaves, access permissions are removed but the account name remains to prevent reuse. Since most systems store not only the username but also the full name of the person using that account (thereby making the association of username and person), permanently retaining the account also keeps the connection to the actual person. If a system does not do this automatically, the connection must be retained through some paper method. In fact, many data management groups keep a paper account record of the person\u2019s full name, signature, initials, and username when a new account is created. The need to keep the connection to a real name brings up one more common problem: having two people with the same name working at the same time. This is not the same case that we just considered. In that case, the username may be reused but the first person was Julia Smith and the second person coming along later was John Smith. In this case, we have people with the same name, two Julia Smiths, for example, working in the group at the same time. Because the system enforces unique user names, one of user names may be jsmith and the other may be jsmith2. Recording the owners of both of those names as Julia Smith would probably not be considered sufficient identification for a serious audit\u2014after all, which Julia Smith was it? When tracking user names, either on paper or electronically, record either the middle initial or a birth date or some other information to differentiate the two. This same differentiation probably has to be carried over to training records, signatures on documents, initials on actions performed, and so forth. Rather a bother for the indi- viduals involved, but the idea of attribution is important in the eyes of the FDA.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Passwords", "definition": "The password in combination with the username is what makes the attribution work. It is equivalent to the signature of the person doing the work and says, \u201cYes, I per- formed this action.\u201d Most companies in the industry are aware of good password procedures and implement them for corporate-level access to networks. Standard practices include the following: \u2022 Only the user knows the password, not the administrator. \u2022 The password has a minimum length (generally eight characters or more). \u2022 The password must be changed on a regular basis (definitely less than a year) and cannot be immediately reused. Controlling Access and Security 157 \u2022 Many companies also require at least one character in passwords that is not a letter and that the passwords not appear in a dictionary. \u2022 No one should do work while signed in as another person. That can be con- strued as falsification should the data come into question. These procedures comply with the FDA\u2019s recommendations (found in the responses to comments in the preface to 21 CFR Part 11), which recommend enforc- ing procedures to make it less likely that a password could be compromised. While IT groups regularly enforce these standards for the company network, not all data management system administrators configure their applications the same way. A surprising number of companies, when audited, are found not to require regular password changes, nor do they enforce minimum lengths. A bit of digging has also turned up cases where employees change their passwords repeatedly when they expire to get back to their favorite password. In the same comments section of the regulation, the FDA says, \u201cAlthough FDA agrees that employee honesty cannot be ensured by requiring it in a regulation, the presence of strong account- ability and responsibility policies is necessary to ensure that employees understand the importance of maintaining the integrity of electronic records and signatures.\u201d Some groups try to make clear to their employees (temporary as well as perma- nent) the importance of good password control by making them sign a statement acknowledging that they understand the seriousness of not adhering to company account management policies, but many still do not see it and it is hard for manag- ers to detect poor password maintenance.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Account Timeouts", "definition": "Another often neglected situation is that of an employee walking away from their computer to get coffee. If they are logged on at that point, someone else could sit down and access the data. This is clearly not desirable as the comments section of the rule also states: \u201cThe agency\u2019s concern here is the possibility that, if the person leaves the workstation, someone else could access the workstation (or other com- puter device used to execute the signing) and impersonate the legitimate signer by entering an identification code or password.\u201d They go on to recommend an automatic disconnect or locking of the screen so that the user has to sign on again to continue. At some companies, this is a network setting; at others it is a setting of the data management application. However it is accomplished, such controls should be in place and the idle time setting, the number of minutes after which the systems locks, should not be set too high or it is of no value. New technology should help in the future as there are already devices that will lock the computer activity when the user, who is wearing or carrying a signal device in a badge, moves a given distance away from the computer.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ACCESS CONTROL", "definition": "For the purposes of this chapter, access control is the combination of systems and procedures that define what access rights or permissions users have to the clinical 158 Practical Guide to Clinical Data Management, Third Edition data in a clinical data management system. (Access rights for EDC systems are a bit different but the information in this section can easily be extended to cover those as well.) Data management systems all have support for granting and revoking access to studies, but the systems available may not meet all the needs of a data manage- ment group. In that case, other procedures, with appropriate controls, should be put in place to fill the gaps. No matter how it is accomplished, systems and procedures should be able to answer these questions: \u2022 Who had access to a particular study? \u2022 When did they have access? \u2022 What were they allowed to do? This is recommended in the FDA guidance \u201cComputer Systems Used in Clinical Investigations.\u201d", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "THE CRO MYTH", "definition": "It is a myth that using a CRO means the sponsor offloads all of the work involved in the project or that portion of the project that is contracted out. Contracting with a CRO to carry out data management for a particular study does not mean that the sponsor\u2019s data management group is freed from involvement with the study! It is only 162 Practical Guide to Clinical Data Management, Third Edition through close involvement from the time of study setup, throughout study conduct, and through database lock and final transfer that a sponsor can feel confident in the quality of the data associated with the study. It is by establishing a base knowledge of the CRO\u2019s compliance with regula- tions and industry standards that the relationship gets underway. This baseline is established via an audit of the CRO. Then, for each project, both sides must clearly define their responsibilities so that no critical data management step is overlooked. To really understand the data and its quality, the sponsor liaison must stay closely involved in the project through ongoing review of materials, oversight of milestones, and constant discussions about the handling of problem data. After study closeout, the sponsor must ensure that the CRO transfers all data and items for the trial master file. To provide a sponsor contact and to keep closely involved with the study, a spon- sor\u2019s data management group should designate a CRO liaison from data management who is an experienced data manager knowledgeable in all aspects of clinical data management (CDM).", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AUDITING CROs", "definition": "A sponsor is ultimately responsible for the quality and integrity of the data coming from a CRO. It is generally accepted in the industry that a key component of taking on that responsibility is to audit the CRO before (or at least around the time of) begin- ning substantial work with that CRO. Sometimes a company will have the resources to maintain an audit group who will review a CRO\u2019s procedures in all areas of inter- est to the sponsor. This should include someone with data management experience if the CRO will conduct some or all of the data management functions for a study. In smaller companies, or when special expertise is required, data management may be asked to designate an auditor (in-house or contracted) to look specifically at data management functions at that CRO. Auditing usually involves a review of written policies and procedures as well as interviews with CRO staff. Often, the auditor will work off a checklist or question list so that no key items are forgotten. By reviewing documents and talking with staff, the auditor gets an idea of whether the CRO performs up to industry standards and complies with regulations. Needless to say, if required to review data manage- ment practices in detail, the auditor must be very experienced in the field of data management and understand acceptable variations in practices. The auditor\u2019s aim should be to ascertain if the CRO performs data management in an acceptable way, not that the CRO performs data management exactly as the sponsor does. After the audit, the auditor will write up an audit report and highlight any sig- nificant findings\u2014both good and bad. The auditor must be careful to differentiate between noncompliance with regulations and variations in practices. In the first case, immediate action would be expected and the CRO should reply with a detailed reme- diation plan with timelines. In the latter case, the sponsor may have a different opin- ion about what is best practice in a particular area, but the CRO may still be using a fully acceptable approach. When this comes up, and the sponsor wants to continue to work with the CRO, the companies will usually work together to formulate a plan or compromise specific to the study.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Working with CROs", "definition": "167 company and may have limited knowledge of how a clinical trial really works and what is involved in clinical data management. CROs AS FUNCTIONAL SERVICE PROVIDERS The discussion of using CROs to this point has dealt with activities that are fully outsourced. That is, the CRO is using its systems, its standard operating procedures (SOPs), and its staff to perform the contracted activities. Larger companies use CROs to manage staffing of projects, and they have another option in addition to fully out- sourcing the CDM activities. They can contract-in CRO staff to work on the sponsor systems under sponsor oversight and sponsor SOPs. When a CRO is used in this way, it is often called a functional service provider. Essentially, the CRO is supply- ing staff and expertise but not systems. It is very much like hiring a local contractor who works onsite at the sponsor\u2019s offices, but the CRO staff is typically located at the CRO facilities. Staff members working as functional service providers need the same kinds of training as any in-house staff or contractors performing the same activities. SOPs FOR WORKING WITH CROs Many companies will have a corporate-level SOP that lays out the bid process and specific requirements for contracting with a CRO. This would typically include the audit requirement mentioned previously. If that SOP does not exist, data manage- ment can still do the right thing at a department level and push for an audit and develop an appropriate responsibility matrix as part of the contracting process. Data management groups that work frequently (or even exclusively) with CROs can also develop a CRO manual or a CRO oversight SOP to lay out data manage- ment\u2019s expectations explicitly. The document would, for example, require a data management plan from the CRO, along with all edit check specifications and data management self-evident corrections. It would also provide recommended workflows for coding, SAE reconciliation, listing review, and the issuing of manual discrepan- cies. Besides setting clear expectations for the CRO, a manual such as this provides consistency within data management when different data managers are working on projects with different CROs.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CLOSING THE STUDY", "definition": "1. Closeout procedures plus any study-specific tasks 2. For paper studies: database audit plan 3. Approval process needed to lock Associated document(s): Any documents required by the process, data- base audit results (paper), lock approval form 239 Appendix B: Clinical Data", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EDC VENDORS AS CROs", "definition": "When small- or medium-sized data management groups make the leap to EDC, they often contract with an EDC vendor to build the study, manage accounts, and support the technical side of the study. In some ways, the EDC vendor then becomes a CRO whose responsibilities are limited to a portion of clinical data management activi- ties around database creation and support. The vendor should be treated like a CRO, and the suggestions for working well with CROs apply to the EDC vendor as well. In particular, expect to be heavily involved in the start-up activities. Keep in mind that EDC vendors are software companies, not drug development firms. While they will have hired staff familiar with clinical trials, they are not a biopharmaceutical", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDM Systems", "definition": "All data managers work with computer software applications. In the chapters that follow, we will look at the characteristics of traditional clinical data management (CDM) systems and electronic data capture (EDC) systems and then explore the activities around those systems. Given the fast pace of software development and the rapid growth (and failure) of EDC vendors, many data managers are likely to be involved, at least peripherally, in vendor selection and validation of new systems. All data managers who design and/or build study databases need to be aware of change control requirements on study applications and all CDM software. A chapter on software used to code adverse events (AEs) and medications rounds out this section as background for those data managers responsible for the activity. Discussions of system selection, implementation, and validation could take up an entire book in their own right. The following chapters aim to provide an overview without going into exhaustive detail or extensive procedures. 171 19 Clinical Data", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs FOR CDM SYSTEMS", "definition": "The SOPs for CDM systems themselves are those that cover implementation, valida- tion, and change control. These SOPs are often written for an IT group. In smaller or newer companies, data management may have to create these SOPs themselves and the concepts needed are discussed in the chapters that follow. 174 Practical Guide to Clinical Data Management, Third Edition CDM SYSTEMS ARE FOR MORE THAN DATA ENTRY Just as data management is more than data entry, CDM systems are more than data collection tools or data entry applications. Even the smaller vendor products will support the key data management tasks for many studies at a time, with lots of data, while being 21 CFR Part 11 compliant. The larger, more complex (and expensive) systems add on more features for more tasks, greater flexibility, and further options for configuration. They will also be able to handle even larger volumes of data and studies. When looking at CDM systems, it is easy to focus on the screens and entry aspects because they are visible and concrete, but it is the complex functions that support the complex work of data management that should be the deciding factors. 175 20 EDC Systems Electronic data capture (EDC) systems deliver clinical trial data from the investiga- tor sites to the sponsor through electronic means rather than paper case report forms (CRFs). As in paper studies, site staff copies information from source records for most of the clinical trial information for a given subject, but they copy into electronic CRFs (eCRFs) rather than paper ones. In most current EDC systems, the site is online with a central computer and the data is stored only on a central computer. These systems work like, and feel like, the familiar websites we visit to shop for books or shoes. As soon as we make a selec- tion and provide payment information, the order is known to the vendor. Some EDC vendors do provide systems that also allow sites to work offline. These store the data locally until the site initiates a connection. This approach is much like the one used when we enter information on our smartphone and then synch it up with our personal computers later via special applications. There are pros and cons to both of these approaches that we will discuss later in this chapter. EDC systems are optimized for site activities during a clinical trial and typi- cally feature: \u2022 eCRFs for the entry of data \u2022 Support for single-field and cross-field checks on the data that generate", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "queries", "definition": "\u2022 Tools to allow sites to review and resolve queries \u2022 Ways for the sponsor to raise manual queries while reviewing data \u2022 True electronic signatures so the investigator can \u201csign\u201d for the data \u2022 Record or subject locks on the data \u2022 Tools to assist monitoring \u2022 Reports about subjects for the sites and reports for the sponsor about sites \u2022 A portal that provides information about the study to the sites \u2022 A variety of ways to extract the data for review and analysis WHAT MAKES EDC SYSTEMS DIFFERENT? If EDC systems collect the data and manage discrepancies, why aren\u2019t they consid- ered just another kind of clinical data management (CDM) system? The reasons are in fact a bit subtle and hinge on certain aspects of performing data management for clinical trials. Some of the key differences between the two kinds of systems are found in: \u2022 Managing multiple data streams \u2022 How coding is handled \u2022 Location of servers with trial data 176 Practical Guide to Clinical Data Management, Third Edition \u2022 Workflow for study setup \u2022 The need for data repositories", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Multiple Data Streams", "definition": "Today, all but the smallest trials have several streams or sources of data. These include interactive voice response system (IVRS) data, lab data from central labs, laboratory normal values, EKG readings, and even electronic subject diary data. This data must be cross-checked against the subject\u2019s eCRF data during the conduct of the trial to identify discrepancies or unusual occurrences. EDC systems do not support multiple data streams very well. If the data is loaded into the EDC front end, then it must be hidden from the sites or protected so that the data cannot be changed. Adding edit checks to loaded data does not provide much value because any queries would not be directed to the sites but rather to the data source or vendor first. If the data is not loaded, but kept as SAS\u00ae datasets or stored in another database, then the only way to do reconciliation with the eCRF data is to first extract that data. Also, if the electronic data is kept separately, then special procedures must be in place to lock it at the time the EDC data is locked.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Coding", "definition": "Strong support for the coding process, including management of the coding diction- ary, is a typical feature of the larger CDM systems. Those systems support robust automatic coding and maintenance of synonyms and provide tools for making man- ual assignments. (See Chapter 11, \u201cCollecting Adverse Event Data,\u201d and Chapter 26, \u201cCoding Dictionaries and Systems,\u201d for more on coding.) Many current EDC systems may only support import of codes after terms have been coded externally; a few are starting to introduce better support for coding. Where the Servers Are\u2014Hosting Another way that EDC systems differ from classic CDM systems is that the central server storing the data from the trail is typically not the sponsor\u2019s server. EDC appli- cations are most commonly \u201chosted\u201d by the vendor or by some other third party. There are two main reasons for this: 1. There is still some uncertainty as to the interpretation of regulations regard- ing the requirement that a site own or have control of the subjects\u2019 data. Many companies feel that having the data under the total control of the sponsor by having it on a sponsor server violates this regulation. Some oth- ers feel that a sponsor\u2019s own IT department could be considered an appro- priate trusted third party. This discussion will certainly continue for a few more years, but for now, most data managers will see externally hosted EDC applications.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EDC Systems", "definition": "181 a given data manager will participate in will change when a company begins to use EDC, but there is still a need to have a coordination of data storage and cleaning efforts. Data managers are also very likely to continue to play a role in design of the eCRF, database, and edit checks. They may also play more of a role in coordinating the various data streams from a study to assure quality and timeliness of data from labs, coding groups, and IVR systems, as well as the EDC host. At many companies, data managers will continue to play their important role as overseers of data quality as they review data listings, run aggregate checks, and perform simple analyses on the datasets. Some companies that use EDC systems widely have reported that the profile of their data management group changes. They go from having many lower-level staff members for data entry and discrepancy management and fewer senior data man- agers to define databases and oversee data collection to exactly the opposite. With EDC, data managers are more involved in study setup and more complex checking and there is less need for junior or less-experienced staff for entry or discrepancy management. They also require more technical expertise in their data managers than previously. This should be heartening to data managers as it shows a trend to more interesting, senior-level positions being available as we go forward with EDC.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "STUDY SETUP", "definition": "1. Computer system(s) to be used 2. Process to design, build, and test the study database 3. Procedures for release for production 4. Other systems or integrations to be configured Associated document(s): Study database design document; other configu- ration documents, test plans and results, approval for production use", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs FOR EDC", "definition": "Because EDC study workflow is different enough from that for paper studies, stan- dard operating procedures (SOPs) specifically for EDC will be necessary for the usual topics in data management (see Chapter 15 and Appendix B). One SOP that is needed and is not common to paper studies is the procedure to manage the accounts and access for sites. Since groups other than data management, such as IT or even the EDC host, are responsible for accounts, they may be responsible for that SOP.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MAKING EDC SUCCESSFUL", "definition": "To make EDC truly successful, we need to understand how it changes the way a study is conducted. The work is no longer as sequential and well separated among clinical, data management, and biostatistics. The work the groups are doing overlaps more and there is more room for duplication or, much worse, for a step in the process to be overlooked. In particular, if data management alone is given the task to go imple- ment EDC, the project is likely to fail or at least bring little value. It is when the three groups work together to decide what works given the company philosophy and avail- able resources that the project gets off to a good start. Continuing to work together and reevaluating the workflow during the initial studies will have a positive impact on the outcome of the early studies and on the company\u2019s view of EDC as a whole. 183 21 Choosing Vendor", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EVALUATING RESPONSES", "definition": "When the responses to the RFIs arrive, the evaluation team combines the new infor- mation with the initial assessments from the demos and tries to come to some kind of conclusion. This can be a surprisingly difficult task. Each software package will be strong in some areas and weak in others. It should not even be surprising if all the products under consideration end up being weak in an area that the company consid- ers very important. Deciding which of two needs, both initially labeled as \u201cvery important,\u201d is going to be very difficult if the products don\u2019t support those needs equally well. Some companies have tried complex systems of priorities and weighting. Each require- ment in the RFI is given priority, and the product responses are weighted as to how well they meet the requirement. The company then performs calculations or even statistical analyses on the outcomes in an attempt to come up with a clear numeric winner. These numbers help, but the final decision of which product to go with\u2014or to decide not to go with any\u2014will probably come down to a qualitative feel about the product and the vendor rather than a pure score based on features. Many people have found that a gut reaction to vendors based on a demo and an RFI results in the same outcome as a complex numerical analysis. EXTENDED DEMOS AND PILOTS If the goal of the vendor and product evaluation process is to learn as much as pos- sible about whether the product would be successful in the company\u2019s environment, then the list of business needs and the evaluation of responses may not be enough. 186 Practical Guide to Clinical Data Management, Third Edition Many companies find that they need some amount of hands-on time with candidate products to really understand if it will work. If time is short in the evaluation period, an extended hands-on demo is a good option. If time and resources permit, a full pilot of the product (before purchase) may be possible. Neither demo nor pilot would normally be carried out with more than two candidate products\u2014and frequently these tools are used as a final check only of the most probable choice.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Hands-On Demos", "definition": "A hands-on demo takes place either at the vendor or on-site at the company and typi- cally lasts from two to five days depending on the complexity of the system. Having a demo on-site allows more of the company staff to attend all or part of the session. On the other hand, it can be hard to corral all the group members of the evaluation team for the entire period and also keep them focused. Visits to the vendor may incur sig- nificant travel expenses, but they do keep the group more focused. They also provide the group access to more than just one or two of the vendor staff members. The idea behind the hands-on demo is to see if the product would work in the business environment of the company by using data or examples from actual studies. Another goal is to give the evaluation team a real sense of how the product would be used on a day-to-day basis. The evaluation team comes to the demo with sample data or studies to try out in the candidate system. The vendor can perform the more complex tasks with the evaluation team looking on, then turn over the keyboard as much as possible for other tasks. Turning the demonstration into a standard training session usually does not meet the goals of the evaluation team. The success of the hands-on demo will rely on the quality of the people sent by the vendor and on the data or examples chosen by the evaluation team. The examples should reasonably represent actual data or structures that would be used in the prod- uct after implementation. When appropriate, the evaluation team should provide the vendor staff with the data and examples before the demo so that the vendor can do some preparation or setup to keep the hands-on time focused. Note that for complex systems, it would be impossible to touch on all parts or features of the product in depth during the demo period, so the evaluation team should identify ahead of time which features they most want to see.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ESSENTIAL PREPARATION", "definition": "The preparation needed before implementation of a system can begin involves get- ting all the necessary pieces in place. This means acquiring all of the hardware and software identified in the overview. It also means installing that hardware and soft- ware and configuring the software application being implemented. At a minimum, installed software should undergo an installation qualification to demonstrate that it has been properly installed. One common problem in the preparation phase is underestimating the time needed to acquire and install systems. In the case of hardware, implementation teams may be unaware that there could well be a wait time due to vendor lead times for deliv- ery of popular server configurations. Even if there is no delay expected in shipping, the process of ordering and purchasing hardware within companies has become so complex that it, by itself, introduces significant lead time. In the case of software, it may be immediately available, but contract negotiations may take quite a while\u2014 especially if special conditions, extensions, or future expectations are in discussion. The biggest risk in this preparation phase is forgetting the configuration task alto- gether. Most large software systems (and many small systems) allow some variation in the way the product can be used. Each installing company decides how to use it and configures the system appropriately. The configuration may take the form of assigning values to system and user parameters, or it may require more complex setup, such as these for clinical data management software: \u2022 Deciding on and setting workflow states \u2022 Adding company logos \u2022 Developing algorithms (as for autocoders) Implementing New Systems 193 \u2022 Loading large coding dictionaries \u2022 Providing company-specific information (e.g., addresses, protocols, com- pany drugs) The configuration tasks needed for a given software product are frequently dif- ficult to judge and difficult to perform because new users may not understand a product well enough to know what to configure and how. Implementation teams aware of the potential for problems in configuration can try to plan for it by working closely with the vendor to determine what needs to be done and roughly how long it should take. INTEGRATION AND EXTENSIONS The overview of the implementation plan in Appendix D has placeholders for all of the integration links and extensions that are considered integral parts of the system. Figure 22.1 lists some examples of integration points and extensions that might apply to a clinical data management system. An individual section for each integration point or extension allows the implementation team to deal with and track each one Type of Integration or Extension", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Purpose", "definition": "Connect to external AE and drug coding", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "applications", "definition": "An integration; terms to be coded are extracted into the coding application; results are", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "returned to the data", "definition": "Build CRF tracking applications for paper", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "studies", "definition": "An extension when the CDM system does not provide detailed tracking information Use external data-checking programs An integration when external programs such as SAS are used; data is extracted to SAS and discrepancies are loaded back into the system Connect imaging systems for paper CRFs An integration so that data is connected to the CRF image and query forms are connected to query records in the database Use Clinical Trial Systems with EDC An integration to allow site information to be loaded into the EDC system or allow visits to", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "trigger site payments", "definition": "Support SAE reconciliation An extension or integration that supports or simplifies SAE reconciliation by producing combined reports from the safety and CDM", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "System Validation", "definition": "205 would be somewhat less and focus on customization and configuration. The effort for small user-written programs and application-built systems would likely be minimal. However, all validation efforts do need to cover the same points and to provide the same assurance of quality. They must include: \u2022 Requirements and specifications \u2022 A plan to carry out the validation \u2022 Test procedures to provide evidence of proper function \u2022 A summary stating that requirements were met \u2022 Change control to provide continued validated functioning Many may be surprised to hear that they need a validation plan for every study database. This is the case but there are shortcuts for such things. In the case of a data- base application built in a validated clinical data management system, the validation requirements can be met as follows: \u2022 An annotated CRF plus the protocol can act as the specification \u2022 An SOP on building and testing a study database acts as the validation plan \u2022 The entry and edit check testing is filed as the evidence \u2022 A ready for production form acts as the summary of testing \u2022 Change control should be in effect for study databases See Chapter 5, \u201cPreparing to Receive Data,\u201d for additional discussion of study- level validation and Chapter 12, \u201cCreating Reports and Transferring Data,\u201d for vali- dation of reports. It is worth finishing this section with a reminder to apply risk assessment appropri- ately. It really is not necessary to go through validation for little reports or programs that simply provide information. The developer will, of course, test these programs in the normal way but they need not go through formal validation. Reports, utilities, extensions, and customizations that might have impact on the data should be vali- dated, but at a level appropriate to the risk they have on the integrity and interpreta- tion of the data.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Assumptions and Risks", "definition": "The assumptions and risk assessment section may well be the most important section of the entire document. The FDA is heavily promoting an assessment of how critical the software is, and from that, judging the appropriate level of validation and testing required. Section 4.8 of the FDA guidance on \u201cPrinciples of Software Validation\u201d states: \u201cThe selection of validation activities, tasks, and work items should be com- mensurate with the complexity of the software design and the risk associated with the use of the software for the specified intended use.\u201d In other words, work harder on validating the systems and features that are critical to the integrity of the data and less hard on features that are administrative or those that have built-in checks either through technical means or through process procedures. Business Requirements and Functional Specification It is not possible to verify that a system meets its requirements in a known manner without stating what those requirements to be met are. Most validation plans now have two sections: one for business needs or requirements and one for functional specifications. As we saw in Chapter 21, \u201cChoosing Vendor Products,\u201d the business- needs document or list of requirements may already be available from the vendor selection process. For vendor-supplied systems, it is common to refer to the user manual supplied with the system as the functional specification. The manual serves as a description of how the system is supposed to work. It may also be appropriate to include references to release notes, known bug lists, and other supplementary material provided by the vendor to describe the current state of the software.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Installation", "definition": "The installation section of a validation plan serves to document how a system is prepared for use. Planning and documenting the installation procedure has proven to be extremely useful to every company that has done it. Even for the smallest systems, a checklist of what must be done to make the system available can help a company avoid unpleas- ant lapses\u2014assuming the checklist is written before the installation. Note that the installation is often carried out at least twice: once in the testing area or environment and once in the production area. The checklist or procedure also ensures that the installation is performed the same way both times. 202 Practical Guide to Clinical Data Management, Third Edition For larger systems that come with a detailed installation procedure or guide, the installer should document what choices were taken or where deviations from the standard installation were made. Those notes provide a reference of those choices for future installations. When independent consultants or vendor technical staff per- form the installation, companies should make clear that an installation checklist and installation notes are required as a deliverable. Many companies require an installation qualification (IQ) process and some also require an operational qualification (OQ) process. Very few require performance qual- ification (PQ). (There are some very interesting comments on IQ/OQ/PQ in the FDA guidance on validation.) The meanings for these terms are not universal, but the intent is to assure that the system is completely and properly in place and does seem to work. The qualification, installation or operational, usually requires some light level of test- ing or verification of system output. This can be performed using vendor-supplied or custom-built test scripts or using system test programs. If the installer encounters any discrepancies or problems, these must be documented. These discrepancies may be as simple as forgetting a step and having to go back or as serious as a complete inability to install. Very, very few installations take place just once, and these notes on problems will be invaluable at the next installation.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Testing Overview", "definition": "We now recognize that the testing portion of the validation process is only one step of many, but it is frequently the most time- and effort-consuming step of the entire validation process. Controlled testing, with expected results compared to actual out- put, will provide the evidence that shows that the system performs in a known way. For complex systems, the test procedures (test scripts) would be found in one or more separate documents. In that case, the testing section of the validation plan would typically provide a high-level overview of the testing approach and pointers to the other documents. (See Chapter 24 for further discussion of testing procedures.)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Vendor Audit", "definition": "Since the ultimate responsibility for the validation of a system falls on the user, each company must consider whether or not they believe a vendor has provided a quality product when they choose to acquire rather than build a system. Most companies, large and small, conduct vendor audits or surveys to help document their decision to rely on the vendor\u2019s software verification processes. Ideally, the vendor audit would take place before the product decision has been made\u2014more typically, it takes place after the decision but before the system is put into production. The vendor audit should be performed by an auditor experienced with software development as well as the FDA\u2019s guidance documents. This is not a GCP audit in the usual sense; this is an audit of the vendor\u2019s development practices as viewed both from the general software industry practices and from the applicable regulations. The audit may be performed by in-house IT or regulatory staff. Or, the task may be contracted out to a consultant specializing in such audits. Companies must be", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Security Plan", "definition": "Not all validation plans include information on security approaches for new systems. Some companies cover this under general SOPs; others include it in implementation plans or user guidelines specific to the system. When a validation plan does include a security section, the intent is usually to document how security fits into the picture of assuring that the system will run correctly and to show how security will maintain integrity of the data in the new system as per 21 CFR (Code of Federal Regulations) Part 11. This is particularly important when the system in question can\u2019t fulfill all the needs of tracking who had what kind of access and when, and the group must implement specific procedures to fill the gaps (see also Chapter 17, \u201cControlling Access and Security\u201d).", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SOPs and Guidelines", "definition": "In recognition of the fact that a system includes not just computers and software but also people and processes, some companies include a section on SOPs and guidelines in their validation plans. The goal of the section is to identify which SOPs or specific guidelines will apply to the process, including which need to be updated and reviewed. This is meant to provide evidence that the new system is used appropriately.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TRACEABILITY MATRIX", "definition": "We can\u2019t even begin to write test scripts until we know what it is that will be tested during this validation and what it is supposed to do when we try it. The introduc- tion and scope sections of the validation plan tell us what is in and what is out of scope for testing. The user requirements and functional specifications list what the system can do or is supposed to do. Reconciling these two together provide us with a list of features to be tested. We add to this list requirements from 21 CFR (Code of Federal Regulations) Part 11, such as access control or automatic audit trail, which are not explicitly listed in the product\u2019s features. The combined list of all items to test becomes the first column of a table or matrix known as the traceability matrix or testing matrix that will provide an index or overview to test scripts. Additional columns in this matrix indicate where the expected behavior for that feature or function can be found in the specifications. As the scripts are written or laid out, the applicable script and procedure identifiers are added to each row of the matrix. So, for example, if a data management group needs to be able to perform double data entry with third-party arbitration, a few rows of the test matrix make look like those found in Figure 24.1. For User Acceptance Testing, the matrix might include rows as shown in Figure 24.2. 208 Practical Guide to Clinical Data Management, Third Edition", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Each script or test procedure has a header. That header repeats information from the", "definition": "traceability matrix to identify what is being tested and what functional specification applies. The header may also include information on the applicable software version, the original script writer, and perhaps script version information. Scripts also need to identify the prerequisites. This should include what other scripts must be run first, what test data is required, and whether any external files are needed. By reading the header and prerequisites, the tester should know exactly what is needed before the script can be run. The different ways companies choose to specify the actual steps to follow in the script vary in their level of specificity. Some companies may choose to specify the actions in such detail that someone only lightly familiar with the systems can still carry them out. Other companies will describe the actions at a much higher level for knowledgeable system users. For example, an action described at a high level might be: \u201cEnter the test data for the first 10 forms of the eCRF.\u201d The same action with more detailed steps might be written as: 1. Select the Enter function 2. From the Subject menu, select Register 3. Register the test subject 4. Select form 1, Demog 5. Enter the data as shown and click SUBMIT And so on. The level of detail describing the action is dependent not only on the expected tester but also on the level of detail required by the outcome of the test. If a Feature/Requirement", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Two-pass Entry", "definition": "Data Entry Manual, Chapter 2, pages 22\u201328 Test Script 2, Procedures 1 (first pass) and 2 (second pass)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Arbitration", "definition": "Data Entry Manual, Chapter 3, pages 31\u201340 Test Script 2, Procedure 3 FIGURE 24.1 Two rows from a traceability matrix covering double data entry for a pur- chased clinical data management system. This example assumes that the correct storage and retrieval of the entered data is tested separately.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "eCRF", "definition": "Study Database Specification section 1", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "IVRS-01", "definition": "FIGURE 24.2 Several rows from a traceability matrix for user acceptance testing of an EDC study application. The broader categories are further refined in the actual test procedures.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Test Procedures", "definition": "211 through the scripts, the reviewer should read all the user outcomes and make sure they make sense\u2014there is always a possibility that the tester misunderstood the step instructions and went astray without realizing it. The reviewer may also spot cases where the tester reported an outcome that seemed OK at the time but looks suspi- cious in the context of the results of test completion. This may be a discrepancy that should be added to the incident log for this script. After reviewing the results and output, the reviewer turns to any discrepancies or incidents associated with the script. The reviewer adds to the incident description any additional contextual information and begins to research the cause. Discrepancies are not necessarily bugs in the system. They may be due to user errors or script errors. They may also be surprising, but expected, behaviors. And of course, a dis- crepancy may be a real bug or flaw in the system. In addition to determining the cause of the discrepancy, the reviewer deter- mines the appropriate action. For user errors, the script may or may not have to be rerun. For script errors, the script may have to be revised and may, or may not, have to be rerun. For surprising behaviors or bugs, the reviewer may need to be in contact with the vendor and consider some way to document the behavior for future users. When the incident is a real bug, the resolution would be a bug report and a workaround if any (including training). On occasion, there may be no work- around and an entire feature may have to be declared off limits and business plans appropriately revised. Most rarely, a bug would be so serious as to prevent the system from being used. Clearly, the reviewer\u2019s job is a critical one. A person assigned to the role of reviewer should be one of the people most experienced with the system being tested. That person should also have established a means of contacting the vendor (via hotline or email) before the testing begins. In some cases, companies may want to arrange special technical support from the vendor for the reviewer during testing.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TRAINING FOR TESTERS", "definition": "Plan on training the testers on how to test, not just on how to use the system. Testers need to understand that finding problems is a good thing, not a bad thing to be avoided. The goal is to identify all possible issues to make sure there are no large problems hiding behind seemingly insignificant discrepancies in expected results. Train the testers to read the header of the test script first and then review all the steps before carrying them out. Before starting a test script, the tester must make sure that all the prerequisite steps have been met and that all test data and external files are present. The tester should also be sure he or she understands the steps to be carried out and the kinds of output the script requires. Testers also need to be instructed on how to fill out the test script results and label output documents. Explain to the testers that these are regulated documents. They should always use pen and sign and initial as required. They should use actual dates. Testers should never: \u2022 Use pencil or white-out \u2022 Transcribe their messy original results to a clean copy of the script \u2022 Rerun the script without checking with a reviewer All printed output from the testing must be labeled with enough information so that it can be linked to the step that was carried out to create it. Proper identifica- tion also applies to electronic (file) output, but in this case, the identification may be through the filename as the user should not modify the actual output file. All testers should know what to do if there is a discrepancy between the expected outcome of a step and the actual outcome. Training should emphasize that in report- ing the incident, the tester must provide enough information for a reviewer to under- stand what happened and what steps came right before the incident. Testers need to know that they should not continue after a system error message. Rather, they should stop and contact the responsible reviewer to see if that one test, or even all testing, must be halted.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REVIEWING RESULTS", "definition": "Most validation testing does not need to be witnessed as it is conducted. That is, a reviewer typically does not need to be looking over the shoulder of the tester to confirm results on the spot. However, the idea of an observer or on-the-spot reviewer may have value at very high-risk points where the outcome would affect all other procedures. This situation tends to come up more during installation and operational testing phases than it does during user validation testing. For validation testing, a reviewer should go through all the scripts, associated out- put, and incident reports as soon after the script was run as is feasible. While going", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Change Control", "definition": "217 or data management electronic folders. Providing a link to the change log (which has the overview and association to any protocol amendments) through a change number associated with all the documents makes retrieving evidence in case of an audit easy.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Assess the Impact", "definition": "For each change, a user, programmer, or IT staff member assesses the impact on the system or study. The key point is to assess the risks to existing data or data man- agement activities that the change will introduce. In making the assessment of the impact, include information on: \u2022 The amount of time the production system will be unavailable \u2022 Any required changes to documentation 216 Practical Guide to Clinical Data Management, Third Edition \u2022 What, if any, user training is required \u2022 Whether any SOPs are affected \u2022 All interfaces or reports that are affected \u2022 The level of testing or validation required Going through the questions of impact assessment may help clear up the question of whether opening a validation plan is warranted. The greater the impact, the higher the risk, the more systems affected, the more likely the need for a full revalidation. For small, localized system changes, the change control system may fill the need for documentation and testing, whereas it would not be sufficient for covering the infor- mation needed for a more widespread change.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Plan Testing", "definition": "Testing is essential for nearly every change\u2014at an appropriate level. Specific bug fixes to the system can be tested against the conditions that caused the bug origi- nally and against the normal working conditions. System changes that have wider impact may require light testing across many areas or features. New releases of an entire system would typically require complete retesting of the system. For study databases, it is typical to require testing of any new or changed elements similar to that performed prior to production use. As with the assessment of impact, an assess- ment of the level of testing may help determine whether or not a validation plan is warranted. If a lot of testing is required across several areas, then a validation plan may be warranted. For some changes, defining appropriate testing may be surprisingly difficult because they are meant to fix bugs that only show up under rare or unusual circum- stances. In these cases, it may be sufficient to find some way to demonstrate that the change was properly and completely implemented and installed and then to confirm that the normal behavior is unaffected. Checking the implementation may include printing out new configuration parameters, displaying the changed source code, or showing that a patch is now recognized by the system via a special version number.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Document the Outcome", "definition": "When a validation plan is used as part of a system change, the plan will have test scripts associated with it. The validation plan, test scripts, test outcome, and valida- tion summary all need to be retained. It is very likely that systems will have more than one change and more than one set of testing associated with them before a com- plete revalidation. The change control log or system provides the overview, and the details are supported with other documentation. Making a link between the change and documentation is very helpful for systems and can be done by tagging any vali- dation plan or independent test results with a change number. A similar technique is called for when study database changes are made. Phase II and III studies frequently have multiple changes associated with them over the course of a trial. As previously noted, each change will have testing and associated documentation. These documents will go into the data management study binder", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RELEASING CHANGES", "definition": "Whenever possible, the implementation and testing of changes should take place \u201con the side\u201d so that they do not affect production use until after they have been tested and approved. This is not always possible, so testing may have to take place in the production environment. Clearly the system should not be in use at that time, and there must be a way to get back to the original state in case testing turns up a problem. When the testing is complete and all other requirements for documentation, train- ing, review, and so on are met, then the change can be released for production use. The release may involve duplicating the change in the production environment or making the production environment available for use. It is important to record the actual date and time it was released for production and to record who made (and reviewed) the final release. For most, but not all, changes to classic CDM systems, the change is applied to the software, or in the case of a study database change, the change is applied to the data in place. That is, the study data is not moved or copied. This is not true for all EDC systems, some of which require a copy or migration of the data. Some significant updates to the databases underlying CDM systems may also require a migration of the data for studies built with the system. Whenever data is transferred or copied, 21 CFR (Code of Federal Regulations) Part 11 comes into play. When data is migrated or copied, the data must be shown to be complete and unchanged. This is usually done with a comparison of a prechange snapshot of the data to a postchange snap- shot. See Chapter 27 for a further discussion of migrating data.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MedDRA", "definition": "MedDRA is a clinical validated medical terminology list used to classify adverse event information associated with biopharmaceuticals and medical devices. MedDRA was developed by the International Conference on Harmonisation (ICH) under the aus- pices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. An international maintenance and support services organization (MSSO) maintains and updates MedDRA, pro- vides licensing arrangements, and distributes the dictionary. In March 2003, the FDA issued a proposed rule mandating that MedDRA be used for postmarketing submission of individual safety reports. The European Medicines Agency requires that all serious adverse event (SAE) reports and all periodic safety update reports (PSURs) be submitted using MedDRA codes. Japan and Canada also require or recommend the use of MedDRA coding. The sophisticated structure of this dictionary supports reported or low-level terms that map to single preferred terms. These preferred terms in turn have associations with higher-level groups and system organ classes.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WHO Drug", "definition": "The WHO Drug dictionary for medical product information was created by the WHO Programme for International Drug Monitoring and is managed by the Uppsala Monitoring Centre. WHO Drug allows biopharmaceutical companies and regulatory agencies to consistently identify drug names, active ingredients, and therapeutic uses for drugs or compounds typically reported under concomitant or suspect medica- tions. The most recent versions are referred to as WHO Drug Dictionary Enhanced or WHO-DDE. The hierarchical structure of the dictionary includes trade or proprietary names and a preferred or nonproprietary (generic) name. Additional information associated with the drug name includes the manufacturer\u2019s name and whether the drug has a single or multiple ingredients.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USING AUTOCODERS", "definition": "Basic versions of autocoder programs take a reported term and look for an exact match in the lower-level terms column of a dictionary table. These work well with drug and disease dictionaries where the reported terms tend to have little variation. Coding Dictionaries and Systems 221 They do not have as high of a match rate for adverse event terms where the variation in the wording of reported terms is high. More sophisticated autocoders do simple text transformations on the reported term in an attempt to improve the likelihood of a match to the dictionary. The transformations may include removal of punctuation or removal of extraneous words (such as \u201cpatient complains of\u201d). Even the most simple text transformations improve the match rate for adverse event terms. To understand how autocoders work at a specific company, we have to understand the details of the following: \u2022 How the term is collected (as this can impact the coding success) \u2022 The results the autocoder returns when it finds a match \u2022 The support, if any, the autocoder provides when no match is found", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Collecting the Term", "definition": "The first part of the coding process involves collecting and storing the reported term (which may be an adverse event term, a drug name, or a medical history diagnosis). The term is reported on a case report form (CRF) and entered into the database or through an electronic CRF (eCRF) form and is immediately in a database. When entered into an eCRF form, the term is typically \u201ccleaner\u201d than that found on a paper form because on paper, sites tend toward abbreviations and symbols. Misspellings, however, will be common in whatever way the term is reported. In paper studies, data management may find some terms that are hard to read, that contain abbreviations or symbols, and terms that are longer than the database fields. Company-specific guidelines specify how to handle these events in general, and data management should be aware how those guidelines specifically affect the ability of autocoders to code these terms. All variations in the reported term will make coding, especially autocoding, more difficult. Therefore, there is great temptation to make modifications to the term that will make it more standard. Those changes that can be clearly specified by entry guidelines may be allowed. For example, symbols may be left out or replaced with standard text (e.g., \u2191 with increased). Some companies permit correction of obvious misspellings based on a study-specific, predefined list. Other companies feel that \u201cobvious\u201d is unclear to begin with and that staff without medical training may make incorrect assumptions. As a compromise, a few companies have a secondary internal field, which does not appear on the CRF, to collect a version of the reported term that is more standard and more likely to code. For both paper and EDC, the autocoder is not run immediately after a user sub- mits the data. Autocoders are typically run once a day for EDC systems, and once a day but only after second entry (or quality review) for paper studies. Some companies may batch coding work or out-source it to specialized coding firms or contractors, but in all cases, data management or coders should run coding regularly throughout the course of a study rather than at a few milestones or infrequent time points along the way. Coding problems need to be identified on an ongoing basis, just as other discrepancies are, in order to improve the quality and timeliness of resolutions from the site. 222 Practical Guide to Clinical Data Management, Third Edition", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Storing the Results", "definition": "When autocoders successfully find a match, they store the resulting code or pre- ferred term and other information found in the dictionary hierarchy in the database along with the rest of the subject\u2019s data. At some smaller companies, the matches will be left in a coding dataset and joined to the subject data dynamically at the time of analysis. The result of the \u201cmatch\u201d may be nothing more than a code or text associated with the reported term since the additional dictionary information can always be found via the unique code or term. But, as previously noted, dictionaries have auxiliary information associated with a code and this information is typically stored in additional columns or tables linked by code or preferred term. Some com- panies find it convenient to add in that information to the subject or coded record itself. Examples of auxiliary information include body system for adverse events or generic name for drugs. Sophisticated autocoders that support a complex process and more sophisticated algorithms often support information called something like coding status. This sta- tus is associated with the reported term and code to identify how the term was coded. The status values might indicate that the code for a reported term falls into one of these categories: \u2022 Provided automatically by the autocoder from the main dictionary \u2022 Provided automatically by the autocoder from a synonyms table \u2022 Found via lexical transformation \u2022 Assigned by the autocoder but manually overridden \u2022 Manually coded All of these states are used by the autocoder itself to determine future process- ing (e.g., never recode a term that was manually coded or overridden) and by data management reports to identify what coding assignments may require review. For example, many data management groups require review by the medical monitor of all codes assigned manually and review by a specialist of all codes assigned via a lexical transformation.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EFFECTIVE CODING", "definition": "The coding process is most effective when it integrates data management systems, practices, autocoders, data managers, and coding experts into one workflow. Good data management systems and practices will collect adverse event terms accurately and will identify many problem terms early. Autocoders run routinely as part of the data handling will also identify problems and discrepancies early. By giving coding experts access to the output of autocoder runs throughout the study (rather than only at critical points or near the end), they will have more time to devote to resolving problems and reviewing difficult coding decisions. A basic autocoder should be considered a requirement by every company. The more steps of the coding process the autocoder can support, the more effective the process will be. One of the most important features to improve effectiveness is the ability to store the association of new, nonmatching terms to the appropriate codes as synonyms. This both increases match rates over time and also helps ensure coding consistency. For highly varied adverse event terms, an autocoder may have to sup- port text modification algorithms to increase the match rate or to make the manual assignment process more effective. 229 27 Migrating and", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Migration by Hand", "definition": "The more complex the migration and the more complex the data problems, the more complex the tools needed to migrate that data. Complex programs require time for development and validation by sophisticated and experienced programmers. When the job to migrate through tools and programs becomes too big or too expensive, companies should consider migrating by hand\u2014that is, by reentering the data. Even with large volumes of data, experienced data entry staff may be able to reenter the data more efficiently than software tools can. Double entry in particular has a low error rate and even 100% verification can be reasonably cost efficient when carried out by administrative staff. This migration by hand should be an approach of last resort because information about the origin of the records (who originally entered them and when) is lost, as is any original audit trail. (For records submitted to the Food and Drug Administration [FDA], 21 CFR Part 11 requires that the audit trail be retained for at least as long as the electronic record itself.) Migrating Audit Trails For systems that have audit trails, the question arises as to whether the audit trail should be migrated along with the data. The FDA rule on electronic signatures and electronic records requires that the audit trail be accessible for the life of the data. However, this can prove difficult, if not impossible, because audit trails of some older systems are not in a structured form that would allow access and migration. Even accessible audit trail structures may contain less (or more) information than the new system requires. The migration team should review the audit trail structure and migrate it if the systems are compatible. If they are not, companies should consider putting the audit trail in some other archive format that is perhaps not as accessible as the data in the main application but could be reviewed if necessary during an audit of the data. This may mean putting it on the same platform or moving only key pieces of data. It is better, even, to move the audit trail to a different but accessible platform or applica- tion (even PDF files) than to lose the information entirely.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "What to Archive", "definition": "Just archiving the data is usually not enough; if that were the case, saving the SAS extract of the data would satisfy everyone. As we saw in the previous migration discussion, the audit trail should be retained for as long as the records are (see 21 CFR Part 11, Section, 11.10). So the audit trail, at a minimum, must be brought along into the archive. General industry consensus seems to be that as much information 234 Practical Guide to Clinical Data Management, Third Edition about the design and conduct of the study should be brought along as well. This would include database design, coding dictionaries, coding algorithms, derived and calculated values, and cleaning rules. For some systems, this information will be in a proprietary design and cannot be moved electronically. In this case, paper or PDF versions of the information should be obtained before the old system is retired. In other cases, this study information will be available electronically (in Oracle, for example) and can be archived along with or parallel to the data, if care is taken. MIGRATION AND ARCHIVE PLANS Like every other major undertaking we have looked at so far in this book, every migration or archive effort needs a plan. The plan should clearly document the approach being taken for all data and list all of the risks involved. In particular, the plan should specify all points at which verification that the data is a true copy will be provided and what methods will be used to provide that verification. For archiving data, the plan should explicitly list all the components of the original system that will be included in the archive and the formats being used for their storage.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FUTURE DIRECTIONS", "definition": "The whole area of archiving is bound to mature over the next couple of years as companies try out various methods and improve upon standard format models. The FDA issued a guidance document in July of 2002 on the maintenance of electronic records. This guidance was withdrawn when the scope and application 21 CFR Part 11 was reevaluated. Presumably, the agency will issue new guidance on this topic eventually. In the meantime, every company will have to make its best effort, archiving as much as possible in as simple a format as possible, and documenting all decisions and approaches for future reference. 235 Appendix A: Data Management Plan Outline The outline for a data management plan shown in this appendix is just one example of the structure such a plan might take. The section headings that appear here come from the recommendations of the Society for Clinical Data Management (SCDM) combined with actual plans used by a wide variety of data management groups. The main headings identify the task to be described or the information to be provided. The subpoints provide a bit more detail on the kinds of information that might be included if appropriate. The subsections also list some of the documents that might be created or collected to fulfill requirements with the designation of Associated Documents. This basic outline can be easily adapted to studies carried out by a contract research organization (CRO) and studies that use electronic data capture (EDC) rather than paper case report forms (CRFs). As noted in Chapter 1, \u201cThe Data Management Plan,\u201d the level of detail provided by a given group for a given study in such a data management plan could legitimately vary from little to lengthy. In particular, only a reference is needed when a task is fully described by standard operating procedures or guidelines. So, for example, if the process for reconciling serious adverse events (SAEs) is fully described in the company standard operating procedure (SOP) numbered DM-114, then the text under that bullet point would be something as simple as \u201cAs per DM-114. No study- specific instructions.\u201d", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DESCRIPTION", "definition": "1. Protocol title and study number 2. Reference to protocol document RESPONSIBILITIES/SCOPE OF WORK 1. Lead data manager 2. CRO contact information 3. Other relevant responsibilities (e.g., coding) CRF/ECRF DESIGN 1. Who is responsible for design 2. Who needs to sign off and when 3. How revisions are made, approved, and filed Associated document(s): Approved design document 236 Appendix A: Data Management Plan Outline", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRF FLOW AND TRACKING", "definition": "1. For paper studies: the CRF workflow 2. For EDC studies: any paper elements being used (e.g., worksheets, backup SAE forms)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data Entry", "definition": "Perform Discrepancy Management and Query Resolution", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "loads", "definition": "LAB DATA ADMINISTRATION 1. Normal range handling 2. Other lab administration tasks", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAE RECONCILIATION", "definition": "1. Process for reconciliation, including discrepancy handling 2. Frequency Associated document(s): Final approved SAE reconciliation records", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CODING REPORTED TERMS", "definition": "1. All dictionaries and specific versions being used for all items to be coded 2. Autocoding process, algorithms if relevant, software used 3. Workflow for uncoded terms and review/approval requirements 4. Coding conventions specific to this protocol or project Associated document(s): Final approved coding", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "REPORTS", "definition": "1. List of standard reports (e.g., missing pages, outstanding discrepancies) 2. Frequency of reports TRANSFERS OR EXTRACTIONS 1. List of transfers expected or frequency of transfers, if any 2. Process for transfers Associated document(s): Transfer specifications for outgoing transfers INTERIM ANALYSES/LOCKS 1. If any, when in the course of the trial do they take place 2. Process that will be followed at that time; signature requirements if any Associated document(s): Any documents required by the process", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DATABASE CHANGES", "definition": "1. Process that is followed for database changes Associated document(s): Database change log; any output from testing and", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "releasing updates", "definition": "238 Appendix A: Data Management Plan Outline", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Management SOPs", "definition": "The list of standard operating procedures (SOPs) in this appendix is derived from good clinical practices (GCP) and 21 CFR Part 11 requirements, Food and Drug Administration (FDA) guidance documents, the Society for Data Management\u2019s \u201cGood Clinical Data Management Practices\u201d document, and a broad selection of SOPs from companies both large and small. The list is a superset of the topics from those references and sources and is meant to be a comprehensive list of topics to be covered by a standard procedure. Note that: \u2022 Not all of these SOPs are of the same priority. \u2022 Some of the topics could be combined into a single procedure document. \u2022 Some of the topics might be addressed by corporate SOPs or policies. Refer to the relevant chapters of this book for additional details on best practices and documentation. 240 Appendix B: Clinical Data Management SOPs TABLE B.1", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Both", "definition": "FDA guidance documents recommend SOPs on system backups and archiving. For larger companies, this is usually an IT or validation group SOP. 243 Appendix C: CRO-Sponsor", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Paper", "definition": "For paper-based studies there should be a database audit SOP, study-specific audit plan, or the DMP. Requirements may be included in the Study Lock SOP.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Comments", "definition": "Query Management: Issuing, Tracking, and", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EDC", "definition": "For EDC studies, describes what kinds of queries and query responses must be reviewed by in-house staff and covers the responsibilities for review and closing queries. Receiving Electronic Data", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Continued", "definition": "242 Appendix B: Clinical Data Management SOPs TABLE B.1 (Continued )", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Responsibility Matrix", "definition": "Figure C.1 is an example of a responsibility matrix to be used in setting up a contract with a contract research organization (CRO) for a paper trial. Most of the key data management tasks are listed; some of them are broken down in detail. Note that this matrix should indicate not only who performs the work but also who is responsible for review (as shown in the first lines for the data management plan [DMP] and case report form [CRF] development.) It is also possible that the sponsor and CRO both do some of the work. The matrix should be customized for each study and sponsor\u2013 CRO combination as needed to clearly identify the work that is to be done. Figure C.2 is a similar matrix that might apply to an electronic data capture (EDC) study. Particular attention there should be paid to defining involvement during the testing phase of the study build. 244 Appendix C: CRO-Sponsor Responsibility Matrix", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRO", "definition": "Write and Maintain Data Management Plan", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Review", "definition": "Develop Help Text and Completion Guidelines Define Database Characteristics Specify Edit Checks (manual and automatic) Build the EDC Application (includes unit test)", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Build the Database", "definition": "\u2022 Write specifications \u2022 Design \u2022 Testing Program and Validate Edit Checks Image CRF Pages and Query Forms", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Track CRFs", "definition": "Generate Weekly Reports \u2022 Missing/expected pages \u2022 Discrepancy counts including time outstanding Perform Clinical Data Reviews Administer Central Lab Data \u2022 Define lab transfer agreement \u2022 Receive lab data \u2022 Manage lab normals \u2022 Check lab data (specify specific checks) \u2022 Contact lab to resolve data issues Receive and Manage Assay Data \u2022 Define transfer agreement \u2022 Receive data transfers \u2022 Check electronic data (specify specific checks) \u2022 Contact provider to resolve data issues Conduct Database QC (quality control) Audit \u2022 Frequency \u2022 Special milestones \u2022 Final audit Transfer Data to Sponsor Transfer Specification", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Code Reported Terms", "definition": "\u2022 AEs \u2022 Medications Perform SAE reconciliation", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Approve Study Lock", "definition": "FIGURE C.1 Data management responsibility: Paper-based study. Appendix C: CRO-Sponsor Responsibility Matrix 245", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Approve Online eCRF", "definition": "Create Validation/UAT (user acceptance testing) Plan Perform System Testing Perform Query Management \u2022 Review queries closed without data updates \u2022 Create manual queries as needed Generate Weekly Reports \u2022 Missing/expected pages \u2022 Discrepancy counts including time outstanding Perform Clinical Data Reviews Administer Central Lab Data \u2022 Define lab transfer agreement \u2022 Receive lab data \u2022 Manage lab normals \u2022 Check lab data (specify specific checks) \u2022 Contact lab to resolve data issues Receive and Manage Assay Data \u2022 Define transfer agreement \u2022 Receive data transfers \u2022 Check electronic data (specify specific checks) \u2022 Contact provider to resolve data issues Transfer Data to Sponsor Transfer Specification", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Create Site PDFs", "definition": "Create PDFs for Sponsor FIGURE C.2 Data Management Responsibilities: EDC study. 247 Appendix D: Implementation", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Plan Outline", "definition": "This example outline for a validation plan applies to a vendor-supplied software application. It includes elements common to most validation plans but the actual names, organization, and grouping of the various requirements would vary from company to company. This outline shows mostly high-level headings; the description of what might be included under each heading can be found in detail in Chapter 23. 1. Introduction and Scope 1.1", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Hardware", "definition": "1.2 Options 1.3 Project Plan/Timeline 2. Assumptions and Risk Assessment 3. Business Requirements 4. Functional Specification 5. Installation/Implementation 5.1 Installation Procedure 5.2 Installation/Implementation Notes 5.3 Installation Qualification 6. Testing Overview 7. Vendor Audit Summary 8. Security Plan 9. SOPs and Guidelines 10. Completion Criteria 11. Revision History 251 Appendix F: CDISC and HIPAA New data managers and others concerned about proper data management often ask about the CDISC and HIPAA and how they impact data collection. CDISC is a standards format and HIPAA is a privacy rule. This appendix provides a very brief explanation of each as well as links for more detailed information.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDISC", "definition": "CDISC stands for the Clinical Data Interchange Standards Consortium. The mission of this independent group is to develop and support global, platform-independent data standards that enable information system interoperability or interchange in medical research. Their goal is to develop standard models that still permit flex- ibility in research. The group has done most of its work in the study data tabulation model (SDTM), which is the standard for regulatory submission of case report form data tabulations from clinical trials. The Food and Drug Administration (FDA) already accepts data in SDTM and most companies are moving in this direction. There is a proposed rule being considered that will require data being submitted in electronic format conform to standardized data structures, terminology, and codes. Many sponsors also request that data sent to them from contract research organizations (CROs) or other vendors be consistent with this model. CDISC also has other standard models including an Operational Data Model (ODM) for the interchange and archive of data collected in clinical trials through a variety of sources. This would include not only the data but also the audit trail and metadata (structural and/or administrative data). The important point at this time is that the model is for writing and reading of files for interchange\u2014it is not meant to replace standard clinical data management systems. However, electronic data cap- ture (EDC) systems could write ODM-compatible files and those files could be read into the clinical data management (CDM) system through an ODM reader utility. An initial version of a Clinical Data Acquisitions Standards Harmonization (CDASH) standard has also been released that connects to ODM. Data management groups have begun exploring these standards to see how they can facilitate building of stud- ies and transformation of the database to STDM for submission. More companies will begin to work with CDISC as more tools are available from vendors, but at this writing, it appears that it will be several years yet before the impact on data management will be clear. Data management groups would be wise to stay current with CDISC. The group has speakers that present sessions at many conferences and also has workshops on the standards. More information can be found at http://www.cdisc.org. 252 Appendix F: CDISC and HIPAA", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HIPAA", "definition": "HIPAA is the Health Insurance Portability and Accountability Act of 1996. It is a federal law, and like 21 CFR (Code of Federal Regulations), it covers quite a range of topics. The sections that most apply to data management are those on privacy. (See 45 CFR Parts 160 and 164 for the actual rule.) The rules apply to covered entities, which are generally people (such as your private physician) or organizations (such as medical centers or research hospitals). Those entities may not transfer identifiable data to another organization without explicit permission from the patient for each transfer. Sponsors of clinical trials are able to receive datasets that identify each patient (albeit without an actual name) because the rule has provisions for research. Those provisions require the consent of the patient for the purpose of a single study. The informed consent document that patients in clinical trials sign, or a separate HIPAA waiver, serves this purpose. Data management groups that work with research institutions occasionally get calls from those sites asking that some data fields be removed from the CRF. Most often the field in question is the birth date. Some sites request that only the year be provided. Should the sponsor not be able to convince the institution that the data is permitted, the database design must handle partial birth dates. Patient initials are another kind of identifying field that may be called into question. Data managers can attend short introductions to HIPAA offered by a wide range of groups and private instructors. The National Institutes of Health (NIH) publishes use- ful material to explain the rule and its impact on clinical research. In particular, refer to its web publication \u201cClinical Research and the HIPAA Privacy Rule\u201d and other useful materials found at http://privacyruleandresearch.nih.gov/clin_research.asp. 253", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Bibliography", "definition": "FDA, 21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule. Federal Register Vol. 62, No. 54, 13429, March 20, 1997. FDA, Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance. FDA, Part 11, Electronic Records; Electronic Signatures\u2014Scope and Application, 2003. FDA, General Principles of Software Validation; Guidance for Industry and FDA Staff, 2002. FDA, Guidance for Industry; Computerized Systems Used in Clinical Investigations, 2007. MedDRA MSSO 2011, MedDRA Term Selection: Points to Consider, Version 4.1. http://www. meddramsso.com/files_acrobat/ptc/9491-1400_TermSelPTC_R4_1_mar2011.pdf. Society for Clinical Data Management, Good Clinical Data Management Practices. http:// www.scdm.org/gcdmp/ (accessed July 2011). w w w . c r c p r e s s . c o m", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Prac t ical Guide to", "definition": "CLINICAL DATA MANAGEMENT T h i r d E d i t i o n PHARMACEUTICAL TECHNOLOGY w w w. c rc p r e s s . c o m", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "an informa business", "definition": "6000 Broken Sound Parkway, NW Suite 300, Boca Raton, FL 33487 711 Third Avenue New York, NY 10017 2 Park Square, Milton Park Abingdon, Oxon OX14 4RN, UK The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of P actical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what\u2019s new in the Third Edition: \u2022 A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow \u2022 Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout \u2022 Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.", "sources": [ "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf" ], "source": "Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AAB", "definition": "American Association of BioAnalysts A national professional association whose members are clinical laboratory directors, owners, supervisors, managers, medical technologists, medical laboratory technicians, physician office laboratory technicians and phlebotomists. AAB is committed to the pursuit of excellence in clinical laboratory services by enhancing the professional skills of each of its members; promoting more efficient and productive operations; offering external quality control programs; collaborating with other professional associations and government agencies; promoting safe laboratory practices; and educating legislators, regulators, and the general public about clinical laboratory tests and procedures. http://www.aab.org/aab/default.asp", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AABB", "definition": "(formerly American Association of Blood Banks), now just known as AABB International non-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies, specifically ones based on hematopoietic stem cells . Virtually all major blood banks in the United States are voluntarily accredited by the AABB with more than 80 percent of hospital transfusion services and similar facilities in the US being members. In 2005 the organization changed its name to AABB to reflect the changes in scope and operations. http://www.aabb.org/Pages/default.", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Chemistry", "definition": "An international society comprised of medical professionals with an interest in clinical chemistry, clinical laboratory science, and laboratory medicine. http://www.aacc.org/Pages/default.", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AAFS", "definition": "American Academy of Forensic Sciences A multi-disciplinary professional organization that provides leadership to advance science and its application to the legal system with the objectives to promote professionalism, integrity, competency, education, foster research, improve practice, and encourage collaboration in the forensic sciences. http://www.aafs.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ABP", "definition": "American Board of Pathology The American Board of Pathology is the certifying board for physicans seeking or maintaining a specialty certificate as a Pathologist. http://www.abpath.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Affordable Care Act", "definition": "The Patient Protection and Affordable Care Act (PPACA), also known as the federal health care law, is a 2010 US federal statute to decrease the number of uninsured Americans and reduce the overall cost of health care. https://www.healthcare.gov/law/feat ures/index.html", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ACLA", "definition": "American Clinical Laboratory Association A not-for-profit organization created in 1971 which offers members the benefits of representation, education, information and research, in order to facilitate advocacy for laws and regulations recognizing the essential role that laboratory services play in delivering cost-effective health care; encourage the highest standards of quality, service and ethical conduct among its members; and promote public awareness about the value of laboratory services in preventing illness, diagnosing disease, and monitoring medical treatment. http://www.acla.com/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ACLPS", "definition": "Academy of Clinical Laboratory Physicians and Scientists An organization dedicated to the advancement of teaching and scholarship in laboratory medicine. http://www.aclps.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ACO", "definition": "Accountable Care Organization Coordinated care systems in which providers are incentivized on the basis of outcomes rather than the number of services. http://www.gpo.gov/fdsys/pkg/FR- 2011-11-02/pdf/2011-27461.pdf", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ADASP", "definition": "Association of Directors of Anatomic and", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Surgical Pathology", "definition": "An organization comprised of directors of anatomic and/or surgical pathology from academic institutions, that promotes expertise and education of pathologists and other healthcare professionals in the field of anatomic pathology and related disciplines. http://www.adasp.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AFIP", "definition": "Armed Forces Institute of Pathology Founded in 1862 as the Army Medical Museum in Washington, D.C., AFIPs primary purpose was to provide a second opinion diagnostic consultation on pathologic specimens such as biopsies from military, veteran, and civilian medical, dental, and veterinary sources. AFIP was closed in September, 2011. http://www.nlm.nih.gov/hmd/medto ur/afip.html", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AJCC", "definition": "American Joint Committee on Cancer An organization that provides leadership in the development, promotion and maintenance of evidence-based systems for the classification and management of cancer. https://cancerstaging.org/Pages/def ault.aspx CAP Glossary of Clinical Informatics Terms 1 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Link", "definition": "CAP Glossary of Clinical Informatics Terms", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Association", "definition": "An international association of over 1,800 clinical laboratory professionals that provides support, resources and advocacy in the clinical laboratory industry to enhance the image and increase the visibility of the laboratory management profession. http://www.clma.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Immunologists", "definition": "A society of medical and scientific professionals, including veterinary and dental, enjoined to improve the practice and study of medical laboratory immunology. http://www.amli.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AMP", "definition": "Association for Molecular Pathology An organization comprised of molecular pathologists, clinical laboratorians, clinical or basic research scientists, reagent/ instrument manufacturers, bioinformaticists, teachers, mentors, students and public servants, who promote the highest quality of molecular diagnostics to improve patient care. AMP is a community that fosters and advances excellence in innovation, translational research, education, training, and clinical practice. http://www.amp.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ANSI", "definition": "American National Standards Institute A private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States for consumer and environmental safety, while strenghtening the U.S. marketplace position globally by coordinating U.S. standards with international standards so that American products can be used worldwide. http://www.ansi.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "APHA", "definition": "American Public Health Association A public healthcare professional organization aimed at protecting all Americans and their communities from preventable, serious health threats and ensuring that preventative health services are universally accessible", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "APHL", "definition": "Association of Public Health Laboratories A U.S. membership organization comprised of public health laboratories for the promotion of policies that support healthy communities. http://www.aphl.org/Pages/default.a", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "API", "definition": "Association for Pathology Informatics A non-profit organization whose mission is to promote the field of pathology informatics as an academic and a clinical subspecialty of pathology by supporting advances in the field of Pathology Informatics through research, education, scientific meetings, and through electronic and printed communications. http://www.amp.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Reporting", "definition": "A profile within IHE AP that provides templates for building surgical pathology reports (cancers, benign neoplasms as well as non-neoplastic conditions). http://www.ihe.net/Technical_Fram eworks/#anatomic", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Act of 2009", "definition": "An economic stimulus package enacted by the 111th United States Congress in February 2009 and signed into law on February 17, 2009, by President Barack Obama. The ARRA created the HITECH Act for healthcare meaningful use. Also referred to referred to as the Stimulus or The Recovery Act http://en.wikipedia.org/wiki/America n_Recovery_and_Reinvestment_A ct_of_2009", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ASC", "definition": "American Society of Cytopathology A national professional society of physicians, cytotechnologists and scientists dedicated to improving patient care in regards to the cytologic method of diagnostic pathology. http://www.cytopathology.org/ ASCLD/LAB PRC American Society of Crime Laboratory Directors/Laboratory Accreditation Board Proficiency Review Committee Proficiency Review Committees (PRC) are established for each forensic discipline accredited by ASCLD/LAB. The PRCs are tasked with reviewing the proficiency test results of accredited laboratories in the corresponding discipline. http://www.ascld-lab.org/proficiency- review-committees/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ASCLS", "definition": "American Society for Clinical Laboratory", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Science", "definition": "Canada's national certifying body for medical laboratory technologists and medical laboratory assistants. http://www.csmls.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ASCP", "definition": "American Society for Clinical Pathology ASCP is a professional membership organization for pathologists and laboratory professionals, whose mission is to provide excellence in education, certification and advocacy on behalf of patients, pathologists and laboratory professionals across the globe. http://www.ascp.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and Immunogenetics", "definition": "An international non-profit association of professionals dedicated to advancing the science, education, and application of immunogenetics and transplant immunology. http://www.ashi-hla.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ASIP Sante", "definition": "French Agency of Shared Healthcare", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Information Systems", "definition": "An agency of the French government and one of three sponsors of IHE Lab, whose mission is to strengthen public ownership of the information systems being developed in the healthcare. http://esante.gouv.fr/en 2 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ATA", "definition": "American Telemedicine Association A non-profit organization whose goal is to promote access to medical care for consumers and health professionals via telecommunications technology. http://www.americantelemed.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Bioinformatics", "definition": "An interdisciplinary scientific field combining computer science, statistics, mathematics and engineering, for the purpose of developing methods and software tools that are used for storing, retrieving, organizing and analyzing biological data, especially as applied in molecular genetics and genomics. http://en.wikipedia.org/wiki/Bioinfor", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CAH", "definition": "Critical Access Hospital Small, rural hospitals that are structured differently than acute care hospitals. Some of the requirements for CAH certification include having no more than 25 inpatient beds; maintaining an annual average length of stay of no more than 96 hours for acute inpatient care; offering 24-hour, 7-day-a-week emergency care; and being located in a rural area, at least 35 miles drive away from any other hospital or CAH (fewer in some circumstances). http://www.cms.gov/Outreach-and- Education/Medicare-Learning-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CCD", "definition": "Continuity of Care Document XML based document standard developed by the HL7 organization and specifies the encoding, structure, and semantics of a patient summary clinical document for exchange. It is a constraint on CDA and contains US specific requirements. http://en.wikipedia.org/wiki/Continuit y_of_Care_Document", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDA", "definition": "Clinical Document Architecture An HL7 document markup standard that specifies the structure and semantics of \"clinical documents\" for the purpose of exchange between healthcare providers and patients. It can contain any type of clinical content \u2013 eg, Discharge Summary, Imaging Report, Admission & Physical, Pathology Report and more. The most popular use is for inter-enterprise information exchange, such as is envisioned for a US Health Information Exchange (HIE). http://www.hl7.org/implement/stand ards/product_brief.cfm?product_id= 7", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDC", "definition": "Center for Disease Control and", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Prevention", "definition": "The national public health institute of the United States that is a federal agency under the Department of Health and Human Services, headquartered in Georgia. Its main goal is to protect America from health, safety and security threats, both foreign and in the U.S., through the control and prevention of disease, injury, and disability. http://www.cdc.gov/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Consortium", "definition": "A multidisciplinary, neutral, non-profit standards developing organization that develops and supports global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. http://www.cdisc.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Technology", "definition": "Founded in 1901 and prior to 1989 was known as the National Bureau of Standards (NBS), NIST is one of the nation's oldest physical science laboratories, providing measurement standards in the U.S. NIST measurements support the smallest of technologies to the largest and most complex of human-made creations. http://www.nist.gov/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CFR", "definition": "Code of Federal Regulations The codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. http://www.gpo.gov/fdsys/browse/c ollectionCfr.action?collectionCode=", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Product List", "definition": "The authoritative, comprehensive listing of certified Complete Electronic Health Records (EHRs) and EHR modules, published by the ONC. http://www.healthit.gov/policy- researchers-implementers/certified- health-it-product-list-chpl", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CISC", "definition": "Clinical Informatics Steering Committee CAP committee that reports to the Council on Scientific Affairs (CSA) and presides over the Informatics Committee and PERT committee. http://capnet/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CISH", "definition": "Chromogenic in situ hybridization A practical, cost-effective, and valid alternative to fluorescent in situ hybridization (FISH) testing for gene alteration, in that it does not need expensive fluorescence microscopy instrumentation / expertise, and the chromogenic agents used in most CISH methods are chemically stable and do not fade over time, allowing easy storage and repeated re-examination of samples. http://www.cytotest.com/cish.asp", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CLC", "definition": "Clinical Laboratory Coalition An organization committed to ensuring access to high quality laboratory services. http://www.aab.org/NewsBot.asp?M ODE=VIEW&ID=209 3 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Amendments", "definition": "Federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. Clinical laboratories must be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. http://wwwn.cdc.gov/CLIA/Default.a", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Advisory Committee", "definition": "A diverse committee managed by the Centers for Disease Control and Prevention (CDC), that provides scientific and technical advice and guidance to the Department of Health and Human Services (HHS), pertaining to general issues related to improvement in clinical laboratory quality and laboratory medicine practice, as well as possible revision of the CLIA standards. http://wwwn.cdc.gov/CLIAC/default.", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Informatics", "definition": "The application of information management in healthcare to promote safe, efficient, effective, personalized, and responsive care. Clinical informatics benefits individuals, institutions, populations, and communities. (from CAP Clinical Informatics Strategy, 2013) http://www.amia.org/applications- informatics/clinical-informatics", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Program", "definition": "Created by an agreement between the Department of Health and Human Services and the Department of Defense (DOD), the DOD Clinical Laboratory Improvement Program (CLIP) authorized the Assistant Secretary of Defense for Health Affairs to develop CLIA'88-comparable regulations for governing DOD laboratories. In implementing the DOD program, the CLIA'88 regulations were adopted to the maximum extent possible and modified only as required to meet those unique DOD missions that precluded", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CLSI", "definition": "Clinical and Laboratory Standards Institute (formerly NCCLS) A volunteer-driven, membership-supported, not-for-profit, standards development organizationthat promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community. http://clsi.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CMS", "definition": "Centers for Medicare and Medicaid Services (formerly HCFA) A federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the State Children's Health Insurance Program (SCHIP), and health insurance portability standards. Additionally, CMS administers standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), ensures quality in long-term care facilities by survey and certification processes, oversees clinical laboratory quality standards under CLIA, and maintains HealthCare.gov. http://cms.hhs.gov/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "COLA", "definition": "Commission on Laboratory Accreditation Formerly known as the Commission on Office Laboratory Accreditation, COLA is a clinical laboratory education, consultation, and accreditation organization. http://www.cola.org/ 4 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Change Proposal", "definition": "Method employed by IHE by which stable, published technical documents can be proposed to be modified by knoweldgeable suggestion by users, vendors or Technical Committee members. These proposals are reviewed by the Technical Committee on a regular bases and then either approved or rejected. http://wiki.ihe.net/index.php?title=C ategory:CPs", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CPOE", "definition": "Computerized Physician Order Entry (Computerized Provider Order Entry) The electronic entry of medical practitioner instructions for the treatment of patients which are communicated over a computer network to the medical staff or to the departments (pharmacy, laboratory, or radiology) responsible for fulfilling the order. CPOE has many benefits including reducing delays in order completion, reduceing transcription errors, and provideing error-checking for duplicate or incorrect doses or tests. http://searchhealthit.techtarget.com /definition/computerized-physician-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CQM", "definition": "Clinical Quality Measure Tools that utilize date in order to measure and track the quality of health care services provided by eligible professionals, eligible hospitals and critical access hospitals, such as treatment, experience, and patient outcomes. CQMs are required as part of meaningful use requirements for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. http://www.cms.gov/Regulations-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRC", "definition": "Chemistry Resource Committee A CAP committee working to improve patient care by promoting the overall quality of laboratory results, evaluating emerging trends, and advising the Laboratory Accreditation Program on issues related to clinical chemistry. http://www.cap.org/apps//cap.portal ?_nfpb=true&cntvwrPtlt_actionOver ride=%2Fportlets%2FcontentViewe r%2Fshow&_windowLabel=cntvwrP tlt&cntvwrPtlt%7BactionForm.conte ntReference%7D=committees%2F chemistry_description.html&_state= maximized&_pageLabel=cntvwr", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CSMLS", "definition": "Canadian Society for Medical Laboratory", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DICOM", "definition": "Digital Imaging and Communications in", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Medicine", "definition": "A special interest group of IHTSDO focused on Pathology and Laboratory Medicine as it relates to SNOMED CT. http://www.ihtsdo.org/search/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DIHIT", "definition": "Diagnostic Intelligence and Health Information Technology See Informatics Committee (ICE) www.cap.org", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Direct Project", "definition": "The Direct Project specifies a simple, secure, scalable, and standards-based way for participants to send authenticated, encrypted health information directly to known, trusted recipients over the Internet. http://wiki.directproject.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DPA", "definition": "Digital Pathology Association A not-for-profit organization comprised of pathologists, scientists, technologists and industry representatives that are focused on facilitating education and awareness of digital pathology applications in healthcare and life sciences. https://digitalpathologyassociation.o rg/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DPS", "definition": "Digital Pathology System An image-based computer system that enables the acquisition, management and interpretation of pathology information generated from a digitized glass slide in order to achieve better, faster, and less costly diagnosis, prognosis, and prediction of diseases. https://digitalpathologyassociation.o rg/_data/files/Archival_and_Retriev al_in_Digital_Pathology_Systems.p", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DRG", "definition": "Diagnosis Related Group A system to classify hospital cases into one of 467 groups, with the last group being \"Ungroupable\", with the intent to identify the \"products\" that a hospital provides. DRGs, used in the US since 1982, determine how much Medicare reimburses the hospital for each \"product\", and are also standard practice for establishing payment for other Medicare related reimbursements. http://library.ahima.org/xpedio/grou ps/public/documents/ahima/bok1_0 47260.hcsp?dDocName=bok1_047 260", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "eCC", "definition": "Electronic Cancer Checklist An electronic version of the more than 70 CAP Cancer Checklists in XML format, that aid pathologists in management of information and in promotion of interoperability, as it offers a standardized way to report cancer data electronically. The CAP Cancer Committee develops these guidelines in collaboration with cancer experts, such as oncologists, radiologists, surgeons, cancer registrars, and other health care professionals. http://www.cap.org/apps//cap.portal ?_nfpb=true&cntvwrPtlt_actionOver ride=%2Fportlets%2FcontentViewe r%2Fshow&_windowLabel=cntvwrP tlt&cntvwrPtlt%7BactionForm.conte ntReference%7D=reference%2Fec c.html&_state=maximized&_pageL abel=cntvwr", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "eDOS", "definition": "Electronic Directory of Service An initiative of ONC Standards and Interoperability (S&I) Framework Laboratory Initiatives Pilots that aims to provide an electronic interchange of a laboratory\u2019s directory of services in an structured format based on HL7 2.5.1. http://wiki.siframework.org/LOI+- +eDOS", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Eligible Hospital", "definition": "Acute Care Hospitals (including Cancer and Critical Access Hospitals) where the Average Length of Stay (ALOS) is 25 days or less. Under the Medicaid EHR Incentive Programs, eligible hospitals can qualify for incentive payments if they adopt, implement, upgrade or demonstrate meaningful use of certified EHR technology during the first participation year or successfully demonstrate meaningful use of certified EHR technology in subsequent participation years. http://www.cms.gov/Regulations-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EHR", "definition": "Electronic Health Record The aggregate electronic record of health-related information on an individual that is created, gathered and shared cumulatively across multiple facilities or healthcare organizations and is managed and consulted by licensed clinicians and staff involved in the individual's health and care. Sometimes used interchangeably with EMR (Electronic Medical Record). http://www.healthit.gov/providers- professionals/learn-ehr-basics", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ELR", "definition": "Electronic Laboratory Reporting The automated transmission of laboratory-related data from commercial, public health, hospital, and other labs to state and local public health departments through an electronic health records (EHR) system or a Laboratory Information System (LIS). ELR is a requirement of Meaningful Use Stage 2. http://wwwn.cdc.gov/nndss/script/m u_elr.aspx", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EMR", "definition": "Electronic Medical Record A digital version of the traditional paper-based medical record for an individual. The EMR represents a medical record within a single facility, such as a doctor's office, clinic, or hospital, and it is the source of data for the EHR. Sometimes used interchangeably with EHR (Electronic Health Record). http://www.himssanalytics.org/docs/ WP_EMR_EHR.pdf", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EP", "definition": "Eligible Professional (also known as Eligible Provider) An eligible professional is a healthcare provider who has demonstrated their understanding of electronic medical records (EMRs) by implementing criteria based on EMR patient updates and Meaningful Use laws. Eligible professionals include Nurses, Physician assistants, Physicians, and Social workers. http://www.healthit.gov/policy-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ePUB", "definition": "Electronic Publication A free and open ebook standard by the International Digital Publishing Forum. http://idpf.org/epub", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FHIR", "definition": "Fast Healthcare Interoperability Resources (HL7 group) (pronounced 'FIRE') A next generation standards framework created by HL7 that is suitable for use in a wide variety of contexts. http://www.hl7.org/implement/stand ards/fhir/summary.html", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FISH", "definition": "Fluorescence in situ hybridization Test method that provides researchers with a way to visualize and map the genetic material in an individual's cells, including specifc genes or portions of genes. Because a FISH test can detect genetic abnormalities associated with cancer, it's useful for diagnosing some types of the disease. In some cases when the type of cancer has previously been diagnosed, a FISH test also can provide additional information to help predict a patient's outcome and whether he or she is likely to respond to chemotherapy drugs. http://www.genome.gov/10000206 6 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FNA", "definition": "Fine Needle Aspiration A diagnostic, minor surgical procedure used to investigate superficial lumps or masses, utilizing a thin, hollow needle inserted into the mass for sampling of cells that, after being stained, are examined microscopically. http://www.ncbi.nlm.nih.gov/pmc/art icles/PMC498011/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "FTP", "definition": "File transfer protocol A standard network protocol used to transfer files from one host to another host over a Transmission Controlled Protocol (TCP)-based network, such as the Internet. FTPs promote sharing of files (computer programs and/or data) and transfer data reliably and efficiently. http://tools.ietf.org/html/rfc959", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Information Set", "definition": "A widely used tool consisting of 81 measures across 5 domains of care in the managed care industry for measuring performance of care and service, developed and maintained by the National Committee for Quality Assurance (NCQA). http://www.ncqa.org/HEDISQuality Measurement/WhatisHEDIS.aspx", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HHS", "definition": "Health and Human Services (Department of) The U.S. governments main agency for protecting the health and providing essential human services of all Americans. http://www.hhs.gov/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HIE", "definition": "Health Information Exchange Created when health care information is electronically collected across organizations within a region, community or health system. Grants to support some of these exchanges were legislated into the HITECH part of ARRA. Sometimes called Regional Health Information Organizations (RHIOs). http://healthit.hhs.gov/portal/server. pt?open=512&objID=1488&parentn ame=CommunityPage&parentid=5 8&mode=2&in_hi_userid=11113&c ached=true", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Systems Society", "definition": "A not-for-profit global organization, founded in 1961, dedicated to imporving healthcare through the optimal use of information technology and management systems. http://www.himss.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Accountability Act", "definition": "A U.S. federal act aimed to improve portability and continuity of health insurance coverage, to combat waste, fraud, and abuse in health insurance and health care delivery, to promote the use of medical savings accounts, to improve access and coverage to long-term care services, to simplify the administration of health insurance, and to ensure an individuals right to medical privacy. http://www.hhs.gov/ocr/privacy/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HIT", "definition": "Health Information Technology The comprehensive management and exchange of health information across computerized systems. http://en.wikipedia.org/wiki/Health_i nformation_technology", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HITECH", "definition": "Health Information Technology for Economic and Clinical Health Act Enacted as part of the American Recovery and Reinvestment Act of 2009, signed into law on February 17, 2009, promotes the adoption and meaningful use of health information technology. http://www.hhs.gov/ocr/privacy/hipa a/administrative/enforcementrule/hit echenforcementifr.html", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HITPC", "definition": "Health Information Technology (HIT)Policy Committee The American Recovery and Reinvestment Act of 2009 (ARRA) provideed that the HIT Policy Committee be created under the Federal Advisory Committee Act (FACA) and charged with making recommendations to the National Coordinator for Health IT on a policy framework for the development and adoption of a nationwide health information infrastructure, including standards, implementation specifications, and certification criteria, for the exchange of patient medical information http://www.healthit.gov/policy- researchers-implementers/health-it-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Standards Committee", "definition": "A federal committee created by the American Recovery and Reinvestment Act of 2009 (ARRA) that advises the Office of the National Coordinator for Health IT (ONC) on matters of standards, certification criteria and other issues surrounding electronic health records (EHRs) and meaningful use. This committee focuses mainly on the policies developed by the health information technology (HIT) policy committee, and also provides for testing of the same by the National Institute for Standards and Technology (NIST). http://www.healthit.gov/facas/health- it-standards-committee", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Standards Panel", "definition": "An organization comprised of healthcare experts from both public and private sectors, created to promote standardization and broad scale interoperability among healthcare applications and information systems. HITSP sponsors numerous specifications that define standards for interoperability and information sharing. http://www.hitsp.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HL7", "definition": "Health Level Seven, Inc. An international standards organization that develops and publishes voluntary consensus technical standards for interoperability of health information technology. http://www.hl7.org/ 7 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ICE", "definition": "Informatics Committee (formerly DIHIT) A CAP committee whose mission is to establish the role of pathologists on the health care team as recognized stewards of clinical and diagnostic data integration and utilization, and reports to the Clinical Informatics Steering Committee (CISC). www.cap.org", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "IDR", "definition": "Integrated Disease Reporting A CAP DIHIT project formed with the intent to develop use cases for next generation reports and the benefits for primary care and mid-level providers. The project will also define \"structured data\" and \"what is a report\" as well as the pathologist role and liability when changing the structure and user interface to meet customer expectations. The output of the efforts will be a White Paper with detailed definitions and requirements for next generation reporting that support interoperability, Meaningful Use, and reuse of data. http://www.pathologyinformatics.org /content/api-webinar-integrated- disease-reporting-order-almost-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "IHE", "definition": "Integrating the Healthcare Enterprise An initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information to achieve optimal patient care. There are 12 domains within IHE, including laboratory and anatomic pathology. http://www.ihe.net/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Anatomic Pathology", "definition": "IHE Anatomic Pathology Domain addresses information sharing, workflow and patient care in anatomic pathology, including surgical pathology, cytopathology, autopsy, electron microscopy, and molecular pathology. http://wiki.ihe.net/index.php?title=A natomic_Pathology", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Laboratory", "definition": "IHE Laboratory Domain addresses information sharing and workflow related to in vitro diagnostic testing in both clinical laboratories as well as point of care testing. The IHE Laboratory Domain, established in 2003, manages the Laboratory Profiles and the Laboratory Technical Framework. http://wiki.ihe.net/index.php?title=La", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "boratory", "definition": "IHTSDO\u00ae International Health Terminology Standards Development Organisation\u00ae An international non-profit standards development organisation whose mission is to develop, maintain, promote and deliver medical terminology products in order to improve health in a global scale through the development and application of appropriately standardized clinical terminologies. IHTSDO owns, maintains, and administers the rights to SNOMED CT and related terminology standards. http://www.ihtsdo.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "IICC", "definition": "IVD Industry Connectivity Consortium A global nonprofit organization dedicated to creating and encouraging adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics with the goal to improve healthcare efficiency and patient care. http://ivdconnectivity.org/cms/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ILW", "definition": "Inter Laboratory Workflow An IHE profile that covers the workflow of orders and results beween a requesting lab (providing the specimens and the orders) and a subcontracting lab (performing the tests and reporting the results to the former one). This workflow is able to carry the payors information along with the order. http://wiki.ihe.net/index.php?title=Int er_Laboratory_Workflow", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Informatics", "definition": "The study and application of information management. http://en.wikipedia.org/wiki/Informati", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Interface engines", "definition": "An HL7 interface engine is an interface or integration engine built specifically for the healthcare industry. It connects legacy systems by using a standard messaging protocol. http://www.hl7.com/interface- engine.html", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Standardization", "definition": "An international standard-setting body composed of representatives from various national standards organizations that promotes worldwide proprietary, industrial and commercial standards. http://www.iso.org/iso/home.html", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "In Vitro Diagnostics", "definition": "Tests that can detect diseases, conditions, or infections and may be used in a laboratory or other health professional settings or by consumers' use at home. http://www.edma- ivd.be/index.php?page=About-In-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "JAHIS", "definition": "Japanese Association of Healthcare Information Systems Industry One of three sponsors of IHE Lab, JAHIS is a Japanese organization that strives to improve healthcare information systems, ensuring quality and safety, and promoting standardization in order to contribute to the sound development of the healthcare information systems industry, as well as the improvement of public health, medical and welfare services. http://www.jahis.jp/english/greeting/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LAW", "definition": "Laboratory Analytical Workflow Profile An IHE Lab profile that addresses the exchange of information related to both patient and QC test orders and results between IVD testing systems and health informatics systems to improve interoperability. http://wiki.ihe.net/index.php?title=La boratory_Analytical_Workflow_Profi", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LBL", "definition": "Laboratory Barcode Labeling An IHE Lab profile that supports the robotization of specimen container identification and delivery at blood sample collection time, in the context of laboratory test requests. http://wiki.ihe.net/index.php?title=La boratory_Barcode_Labeling", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LCC", "definition": "Laboratory Clinical Communications An IHE Lab profile that will enable rapid, standardized, and automated capture of electronic communication between the clinician and the laboratory related to orders and questions regarding results. This could be utilized when the laboratory wishes to propose a more appropriate test order to the clinician or the clinician wishes to obtain a pathologist's interpretation of patient results. This information will then be logged, tracked, and included in QA studies and process improvement projects. http://wiki.ihe.net/index.php?title=L CC_Long_Proposal_-_wiki", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LCSD", "definition": "Laboratory Code Sets Distribution An IHE Lab profile that electronically establishes and maintains a common vocabulary between systems involved in laboratories workflows. http://wiki.ihe.net/index.php?title=La boratory_Code_Sets_Distribution", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LDA", "definition": "Laboratory Device Automation IHE Lab profile that covers the exchanges between an Automation Manager (Actor played by a Laboratory Information System or by a Laboratory Automation System) and a set of automated Laboratory Devices to process a Work Order, perform the tests on the related specimens and retrieve their results. This processing includes the pre-analytical process of the specimen (sorting, centrifugation, aliquoting, transportation, decapping) the analytical process itself (run of the ordered tests on the specimen) and the post-analytical process (recapping, transportation, rerun, storage and retrieval). This profile is restricted to operations performed in a clinical laboratory setting and does not include point of care testing. http://wiki.ihe.net/index.php?title=La boratory_Device_Automation", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LDT", "definition": "Laboratory Developed Tests An vitro diagnostic test that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA certificate). LDTs are also sometimes called in-house developed tests, or \u201chome brew\u201d tests. LDTs are considered \u201cdevices,\u201d as defined by the FFDCA, and are therefore subject to regulatory oversight by FDA. When a laboratory develops an LDT in-house without receiving FDA clearance or approval, CLIA prohibits the release of any test results prior to the laboratory establishing certain performance characteristics relating to analytical validity for the use of that test system in the laboratory\u2019s own environment. https://www.cms.gov/Regulations-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LOI", "definition": "Laboratory Orders Interface An S&I Framework iniative that is focused on the development of a Laboratory Orders IG for ambulatory settings that aligns with the LRI IG and ELINCS Laboratory Orders IG, will incorporate support for the adoption and use of the Test Compendium Framework, i.e., eDOS, and develop validation tools to facilitate the evaluation and adoption of the LOI IG. http://wiki.siframework.org/Laborato ry+Orders+Interface+Charter+Page", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Implementation Guide", "definition": "U.S. based Laboratory Results Interface Implementation Guide developed by the S&I Framework LRI Iniative, that provides guidance for ambulatory laboratory to ambulatory provider interfaces for laboratory results. http://www.hl7.org/implement/stand ards/product_brief.cfm?product_id= 279", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and Codes", "definition": "A database hosted by Regenstrief Institute that provides a universal code system for reporting laboratory and other clinical observations which is available in multiple languages. In addition to laboratory tests, LOINC also includes clinical measures, imaging tests, and document architecture. http://www.regenstrief.org/loinc/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LRI", "definition": "Laboratory Results Interface An S&I Framework iniative whose ultimate goal is to develop an Implementation Guide that will define the core data elements required for ambulatory care clinical laboratory test results in the U.S. Realm. The clinical laboratory test results will use standardized structured data so that they can be incorporated into a certified EHR. http://wiki.siframework.org/Laborato ry+Results+Interface+Quickstart+P", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LTW", "definition": "Laboratory Testing Workflow An IHE Lab profile that integrates the ordering, scheduling, processing, and result reporting activities associated with in vitro diagnostic tests performed by clinical laboratories in healthcare institutions, and supports all laboratory specialties with the exception of anatomic pathology. http://wiki.ihe.net/index.php?title=La boratory_Testing_Workflow", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Middleware", "definition": "Software that mediates between an application program and a network. It manages the interaction between disparate applications across the heterogeneous computing platforms. http://foldoc.org/middleware", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Meaningful Use", "definition": "The American Recovery and Reinvestment Act of 2009 specifies three main components of Meaningful Use: 1. The use of a certified EHR in a meaningful manner, such as e-prescribing. 2. The use of certified EHR technology for electronic exchange of health information to improve quality of health care. 3. The use of certified EHR technology to submit clinical quality and other measures. Simply put, \u201cmeaningful use\u201d means providers need to show they're using certified EHR technology in ways that can be measured significantly in quality and in quantity. http://www.cms.gov/Regulations-", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NAACLS", "definition": "National Accrediting Agency for Clinical", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Laboratory Sciences", "definition": "An agency that accredits and approves education programs in the clinical laboratory sciences and related health care professions. NAACLS provides services including program accreditation, program approval, consultation, and continuing education, for educational programs, students, employers, and health care consumers. http://www.naacls.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Biochemistry", "definition": "NACB is the Academy of the AACC comprised of doctoral level clinical scientists and whose mission is to further the practice of clinical biochemistry for the benefit of all. http://www.aacc.org/members/nacb /pages/default.aspx#", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NCCLS", "definition": "National Committee for Clinical Laboratory Standards (Now CLSI) A volunteer-driven, membership-supported, not-for-profit, standards development organizationthat promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community. (see CLSI) http://clsi.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NCI", "definition": "National Cancer Institute Part of the National Institutes of Health (NIH), which coordinates the U.S. National Cancer Program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of cancer; the supportive care of cancer patients and families; and cancer survivorship. http://www.cancer.gov/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Assurance", "definition": "A private, not-for-profit organization founded in 1990, dedicated to improving health care quality, through the administration and utilization of evidence-based standards, measures, programs, and accreditation. http://www.ncqa.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NCRA", "definition": "National Cancer Registrars Association Established in 1974, the National Cancer Registrars Association is a non-profit organization that represents more than 5,000 cancer registry professionals and Certified Tumor Registrars (CTR\u00ae). Its mission is to serve as an education, credentialing, and advocacy resource for cancer data professionals. Cancer Registrars capture a complete summary of the history, diagnosis, treatment & disease status for every cancer patient, which leads to better information used in the management of cancer, and ultimately, cures. http://www.ncra- usa.org/i4a/pages/index.cfm?pagei d=1", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NIH", "definition": "National Institutes of Health The NIH, part of the U.S. Department of Health and Human Services, is the nation\u2019s medical research agency\u2014making important discoveries that improve health and save lives. It is the largest source of funding for medical research in the world. The NIH both conducts its own scientific research through its Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program. http://www.nih.gov/ 10 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NIST", "definition": "National Institute of Standards and", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NLM", "definition": "National Library of Medicine The NLM is operated by the U.S. federal government, and is the world's largest medical library, with over 7 million scientific and medical works. The NLM freely distributes SNOMED CT within the U.S., and also hosts PubMed, which contains over 23 million citations for biomedical literature. http://www.nlm.nih.gov/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ONC", "definition": "Office of the National Coordinator for Health Information Technology (under HHS) A position within the US Department of Health & Human Services (HHS) created by Executive Order in 2004 and written into legislation by the HITECH Act. Its purpose is to promote a national health Information Technology infrastructure and oversee its development. http://healthit.hhs.gov/portal/server. pt?open=512&objID=1200&mode= 2 O&O Orders and Observations An HL7 special committee whose intent is to define information exchange capabilities to support the order/scheduling and clinical event management/reporting requirements between the stakeholders in the healthcare organization regarding patients, non-patients, other species, or inanimate objects. These information exchanges may cross organizational boundaries, and may involve messages, documents, services, and other HL7 constructs. O&O supports the ongoing development of HL7 Version 2.x and ensures that equivalent functionality is present in HL7 Version 3.0 and FHIR. http://www.hl7.org/Special/committ ees/orders/index.cfm", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PathLex", "definition": "Anatomic Pathology Lexicon The PathLex project is an interface terminology launched by IHE and HL7 Anatomic Pathology, with the collaboration of other Anatomic Pathology organizations. The Pathlex project has been \u201cdesigned to satisfy the needs of Anatomic Pathology information system vendors and users by adopting the best features of existing terminology systems, while producing new terms to fill critical gaps\". PathLex unifies and supplements other terminology systems, such as SNOMED-CT, CIM-O or various vocablary tables defined by DICOM and HL7. http://www.google.com/url?url=http: //www.hl7.org/documentcenter/publi c/wg/anatomicpath/20100831_Path Lex.docx&rct=j&frm=1&q=&esrc=s &sa=U&ei=R7y1U_z2AYidyASX2Y CABA&ved=0CCEQFjAC&usg=AF QjCNFRKyevb740dn5uW98hXpraL", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PDF", "definition": "Portable Document Format A file format used to represent documents in a manner independent of application software, hardware, and operating systems. http://en.wikipedia.org/wiki/Portable _Document_Format", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Committee", "definition": "The Pathology Electronic Reporting Committee of the CAP was formed in 2007 to help guide the development and maintenance of the electronic Cancer Checklists (eCC). PERT serves to both oversee eCC informatics issue reconciliation as well as to interact with the CAP Cancer Committee regarding eCC content issues and paper/ electronic checklist release coordination, and reports to the Clinical Informatics Steering Committee (CISC). www.cap.org", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PHI", "definition": "Protected Health Information Any information about health status, provision of health care, or payment for health care that can be linked to a specific individual. This may include any part of a patient's medical record or payment history. http://www.hipaa.com/2009/09/hipa a-protected-health-information-what- does-phi-include/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PHIN VADS", "definition": "Public Health Information Network Vocabulary Access and Distribution", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "System", "definition": "A web-based enterprise vocabulary system for accessing, searching, and distributing vocabularies used", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PHR", "definition": "Personal Health Record A health-related documentation maintained by the individual. http://www.ncbi.nlm.nih.gov/pmc/art icles/PMC1447551/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PHSA", "definition": "Public Health Service Act A U.S. federal law enacted in 1944 to consolidate and revise the laws relating to the Public Health Service. http://www.fda.gov/regulatoryinform ation/legislation/ucm148717.htm", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PPO", "definition": "Preferred Provider Organization A type of health plan that contracts with medical providers, such as hospitals and doctors, to create a network of participating providers. The insured pay a discounted rate when using providers that belong to the plan\u2019s network and a higher rate for providers outside the network. http://www.ehealthinsurance.com/h ealth-plans/ppo/ 11 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RCMT", "definition": "Reportable Condition Mapping Table Mapping tool available through the CDC to provide mappings between reportable conditions and their associated LOINC laboratory tests and SNOMED CT results https://phinvads.cdc.gov/vads/Sear chVocab.action Regenstrief Institute Regenstrief Institute An internationally respected non-profit medical research organization, which developed and now maintains", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RELMA", "definition": "Regenstrief LOINC Mapping Assistant A mapping program to assist the mapping of local test codes to LOINC codes and to facilitate browsing of the LOINC results. http://www.regenstrief.org/loinc/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Research Use Only", "definition": "RUOs are products that have not cleared by the FDA for diagnostic use and should only be used in the research environment. According to the FDA, RUO products are described as products \u201cin the laboratory research phase of development and not represented as an effective in vitro diagnostic product.\u201d http://www.fda.gov/medicaldevices/ deviceregulationandguidance/guida ncedocuments/ucm253307.htm", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAFER Guides", "definition": "Safety Assurance Factors for EHR", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Resilience Guides", "definition": "Nine self-assessment guides for healthcare organizations to use to optimize the safety and safe use of EHR systems. http://www.healthit.gov/safer/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SAFMLS", "definition": "Society of Armed Forces Medical", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Laboratory Scientists", "definition": "A non-profit organization, officially established in 1971, dedicated exclusively for charitable, educational and scientific purposes in relationship to the laboratory sciences. The primary objective is to maintain and enhanc high professional standards through improved laboratory policies and technology in support of the health care delivery systems of the Armed Forces, Public Health Services and Veterans Administration. http://www.safmls.org/ S & I Framework Standards and Interoperability", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Framework", "definition": "The S&I Framework, adopted by ONC's Office of Standards & Interoperability, is a collaborative community of participants from the public and private sectors who are focused on providing the tools, services and guidance to facilitate the functional exchange of health information. The S&I Framework has many different areas of involvement, such as aLOINC Order Code Initiative, Laboratory Results Interface Initiative (LRI), Structured Data Capture (SDC), and many others. http://www.siframework.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SGR", "definition": "Sustainable Growth Rate A formula currently used by the Centers for Medicare and Medicaid Services to control spending by Medicare on physician services. Generally, this is a method to ensure that the yearly increase in the expense per Medicare beneficiary does not exceed the growth in GDP (gross domestic product). The formula limits growth in spending for physicians\u2019 services by linking updates to target rates of spending growth. https://www.cms.gov/Medicare/Med icare-Fee-for-Service- Payment/SustainableGRatesConFa ct/Downloads/sgr2015p.pdf", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SIG", "definition": "Special Interest Group A community within a larger organization that has a shared interest in advancing a specific area of knowledge, learning or technology. SIG members cooperate to affect or to produce solutions within their particular field. http://en.wikipedia.org/wiki/Special_ Interest_Group", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SNOMED", "definition": "Systematized Nomenclature of Medicine older version of SNOMED CT. a systematic, computer-processable collection of medical terms, both human and veterinary, to provide codes, terms, synonyms and definitions which cover anatomy, diseases, findings, procedures, microorganisms, substances, etc. SNOMED was started in the U.S. by the College of American Pathologists in 1973 and revised into the 1990s. In 2002, SNOMED was merged and expanded with the UK National Health Service to become SNOMED CT. http://www.nlm.nih.gov/research/um ls/sourcereleasedocs/current/SNM/ SNOMED CT\u00ae SNOMED Clinical Terms\u00ae A systematically organized computer processable collection of medical terms (over 311,000 concepts) providing codes, terms, synonyms and definitions used in clinical documentation and reporting, originally creatred by the College of American Pathologists. SNOMED CT provides the core general terminology for electronic health records, and is used to encode qualitative laboratory results and microorganism identifications, as well as many other medical terms. SNOMED CT is one of two current terminologies required for Meaningful Use, along with LOINC, for the encoding of laboratory results. http://www.ihtsdo.org/snomed- ct/snomed-ct0/ 12 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocol", "definition": "The networking model and group of communications protocols used for the Internet and similar networks utilizing the Transmission Control Protocol (TCP) and the Internet Protocol (IP), which were the first networking protocols defined in this standard. TCP/IP provides end-to-end connectivity specifying how data should be formatted, addressed, transmitted, routed and received at the destination. http://www.protocols.com/pbook/tcp ip1.htm", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Telemedicine", "definition": "The use of medical information exchanged from one site to another via electronic communications to improve a patient\u2019s clinical health status. Telemedicine includes a growing variety of applications and services using two-way video, email, smart phones, wireless tools and other forms of telecommunications technology. http://www.medicaid.gov/Medicaid- CHIP-Program-Information/By- Topics/Delivery- Systems/Telemedicine.html", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Telepathology", "definition": "A form of communication between medical professionals that includes the transmission of pathology images and associated clinical information for the purpose of various clinical applications including, but not limited to, primary diagnoses, rapid cytology interpretation, intraoperative and second opinion consultations, ancillary study review, archiving, and quality activities. http://www.medterms.com/script/m ain/art.asp?articlekey=33621", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "UCUM", "definition": "Unified Codes for Units of Measure A code system of standardized codes for measurement units used in medicine and pharmacy, based on 7 standard units. This industry standard, in international use since 1999, is published in English by the Regenstrief Institute. Medical documentation IT applications use UCUM for the unambiguous communication of measurements based on standard SI units. Application areas include the representation of laboratory tests, clinical examinations, and pharmaceutical data. http://unitsofmeasure.org/trac/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "UICC", "definition": "Union for International Cancer Control (Union Internationale Contre le Cancer) Previously known as the International Union Against Cancer, the UICC is a membership organisation that exists to help the global health community accelerate the fight against cancer. UICC was founded in 1933 and is based in Geneva, Switzerland, with a membership of over 800 organisations across 155 countries. http://www.uicc.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "USCAP", "definition": "United States and Canadian Academy of", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Pathology", "definition": "An organization with more than 10,000 members whose mission is to provide pathologists with high quality information at the investigative and applied practice level to reinforce and update their knowledge of pathology in their unique area(s) of interest, from anatomic to molecular pathology. http://www.uscap.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VA", "definition": "U.S. Department of Veterans Affairs A U.S. government-run military veteran benefit system that provides patient care and federal benefits to veterans and their dependents. The Department has three main subdivisions, known as Administrations: Veterans Health Administration (VHA), Veterans Benefits Administration (VBA), and National Cemetery Administration. http://www.va.gov/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VPN", "definition": "Virtual Private Network A private network that interconnects remote (and often geographically separate) networks through primarily public communication infrastructures such as the Internet. VPNs provide security through tunneling protocols and security procedures [1] such as encryption. For example, a VPN could be used to securely connect the branch offices of an organization to a head office network through the public Internet. http://en.wikipedia.org/wiki/Virtual_p rivate_network", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WASPaLM", "definition": "World Association of Societies of Pathology and Laboratory Medicine An international organization to improve health throughout the world by promoting the teaching and practice of all aspects of Pathology and Laboratory Medicine, by promoting education, research, and international quality standards, through the Committees and Secretariats of WASPaLM and the World Pathology Foundation. http://www.waspalm.org/", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WHO", "definition": "World Health Organization A specialized agency of the United Nations (UN) established in 1948 that is concerned with international public health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. http://www.who.int/en/ 13 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Whole Slide Imaging", "definition": "Whole slide digital imaging uses computerized technology to scan and convert pathology specimen glass slides into digital images which are then accessible for viewing using a computer monitor and viewing software. This is known as virtual microscopy because the images are viewed without the use of a microscope or slides. http://www.jpathinformatics.org/artic le.asp?issn=2153- 3539;year=2011;volume=2;issue=1 ;spage=36;epage=36;aulast=Panta", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "XML", "definition": "Extensible Markup Language A markup language that defines a set of rules for encoding documents in a format that is both human- readable and machine-readable http://en.wikipedia.org/wiki/Xml 14 of 14", "sources": [ "clinical-informatics-acronym-glossary.pdf" ], "source": "clinical-informatics-acronym-glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Siebel", "definition": "Clinical Trial Management System Guide", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Integration", "definition": "This task describes how to configure the Web services that are required for clinical data management system integration. For more information about configuring Web services, see Integration Platform Technologies: Siebel Enterprise Application Integration . Note: It is recommended that you use HTTPS authentication. For information about configuring Secure Sockets Layer (SSL) for HTTPS authentication, see Siebel Security Guide . This task is a step in Process of Setting Up Clinical Data Management System Integration. To configure Web services for clinical data management system integration 1. Navigate to the Administration - Web Services screen, then the Inbound Web Services view. 2. Query for each of the following Web services, and update the language and address variables: \u25e6 ClinicalSubject Inbound Web service. \u25e6 LS Clinical Protocol Site Interface Service 3. Click Clear Cache on the Inbound Web Services applet. Integrating Data for Subject Visits with Data for Activities Subject visit templates allow you to set up a template schedule. The template schedule is based on the protocol document. You use the template schedule to generate screening, rescreening, and enrollment schedules for each subject, according to the subject\u2019s screening, rescreening, and enrollment dates. The Clinical Item Integration field in the subject visit template is used for integrating visit data with activity data between Siebel Clinical and Oracle Health Sciences InForm. To integrate data for subject visits with data for activities 1. Navigate to the Administration - Clinical screen, then the Visit Templates view. 2. In the Subject Visit Templates list, create a new record and complete the necessary fields. The Clinical Item fields in the Visits and Activities applets are automatically populated. 223", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Siebel Clinical", "definition": "The tasks that a user of the Siebel Mobile application for Siebel Clinical can execute in online and offline mode include the following: \u2022 Getting Started with Siebel Mobile Disconnected Applications (general tasks) \u2022 Switching to Offline Mode and Synchronizing Data \u2022 Managing My Site Visits for Siebel Clinical \u2022 Managing My Sites for Siebel Clinical Note: You must complete the relevant setup tasks detailed in this guide before using the Siebel Mobile disconnected application for Siebel Clinical. Getting Started with Siebel Mobile Disconnected Applications For information about how to get started with Siebel Mobile disconnected applications and about the common procedures that you can execute in online (connected) and offline (disconnected) mode in all applications, see the Getting Started chapter in Siebel Mobile Guide: Disconnected which includes information about the following: \u2022 Logging in to and out of Siebel Mobile \u2022 Navigating the Siebel Mobile user interface \u2022 Managing records in Siebel Mobile \u2022 Reviewing notification messages in Siebel Mobile \u2022 Configuring application settings for Siebel Mobile \u2022 Displaying location details in Siebel Mobile \u2022 Running predefined queries in Siebel Mobile \u2022 Using Attachments in Siebel Mobile \u2022 Printing from Siebel Mobile \u2022 Process of using Siebel Mobile disconnected applications in offline mode 231", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Preface", "definition": "This preface introduces information sources that can help you use the application and this guide. Using Oracle Applications To find guides for Oracle Applications, go to the Oracle Help Center at https://docs.oracle.com/. Documentation Accessibility For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contacting Oracle", "definition": "Access to Oracle Support Oracle customers that have purchased support have access to electronic support through My Oracle Support. For information, visit My Oracle Support or visit Accessible Oracle Support if you are hearing impaired. Comments and Suggestions Please give us feedback about Oracle Applications Help and guides! You can send an email to: oracle_fusion_applications_help_ww_grp@oracle.com.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "What\u2019s New in This Release", "definition": "What\u2019s New in Siebel Clinical Trial Management System Guide, Siebel CRM 25.4 Update The following table lists the changes in this revision of the documentation to support this release of the software.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Description", "definition": "LSClinicalTripReportFileTransferQuery Queries the trip report details based on the given trip report Id or Visit name. For more information, see Request Message for TripReportFileTransferQuery. LSClinicalTripReportFileTransferQueryPage Queries the trip report details in pages based on the given filter criteria. For more information, see Request Message for ClinicalTripReportFileTransferQueryPage. LSClinicalTripReportFileTransferUpsert Either updates the trip report and its child components or inserts new child items to the trip report. For more information, see Request Message for TripReportFileTransferUpsert. Request Message for TripReportFileTransferQuery The following table describes the request message for TripReportFileTransferQuery. Note the following about using the Query method: \u2022 If no input is provided for any tags in the Query method, then the Web service may return an error \u2013 prompting you to refine the search to limit the output result set. \u2022 Use the required tags in the Query method to query the data. For example, to query site visits for a particular", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Charge Sheet Library", "definition": "2. A new attribute, \u2018Charge Sheet Version\u2019 is added to: a. Master Subject Visit Template level: - You can select from Active\u2019 Charge Sheet Versions only. - Charge Sheet version set at this level will be the default Charge Sheet version applied to a new", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PII Detection in CTMS", "definition": "PII Service Setup and Configuration If requires a Siebel Administrator can configure the PII detection service. By default, the system is set to \u2018N\u2019. As an admin in the CTMS system: 1. Navigate to Administration \u2013 Application > System Preferences and search for EnableOCIAILanguage. 2. Set the \u2018System Preference Value\u2019 to Y to use the PII service. Once the System Preference is set, you can configure the fields within CTMS that you want to validate for the PII information. Note: A server restart is mandatory for changes to take effect. 3. In Siebel Web Tools, Search for the component that PII information is required to be validated. For example, if the fields under Trip Report section in CTMS are required to be validated: a. Navigate to the Business Component section. b. Search for Clinical Trip Report. Search for Business Component User Props that contain the word Batch. 4. To configure the fields that you would like to validate for the PII detection: a. Go to Business Component User Properties. b. Search for Batch and set the \u2018text:FIELD\u2019 property with field names that are required to be validated.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Flow", "definition": "Modified topic. Explains how CTMS provides a outbound API to support pushing protocol/subject/SVT details from CTMS to PowerTrials. 1", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Using CTMS Dashboards", "definition": "Status RollUp Fields:Protocol 7: \"# CustomStatus\", \"# CustomStatus\" Status RollUp Fields:Region 7: \"# CustomStatus\", \"# CustomStatus\" BC: Clinical Region Status RollUp Fields 7: \"# CustomStatus\", \"# CustomStatus\" 5. Map this new field on Applet. 6. Navigate to Applet > Search for LS Clinical Site Subjects Infolet Applet. Add this new field in control and web template items. Note: You may need to inactivate any existing Web Template item since the Dashboard can display only 6 items at a time. System Preferences for Dashboards You need to set these System Preferences for DB and Milestone to function properly: System Preference Name System Preference Value CL - Dashboard TR Target CL - Site Status Dashboard Planned,Initiated,Enrolling,Terminated,Not Initiated,Closed 299", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Using CTMS Milestones", "definition": "You can create, track, and complete the milestones required for the Clinical study success. You can also create a milestone library at a customer level, add and modify Study milestone templates, apply a template, and create milestones. This chapter contains the following topics: \u2022 System Preferences for Milestones \u2022 Configuring Email Alerts for Upcoming Milestones and Missed Milestones System Preferences for Milestones You need to set these System Preferences for DB and Milestone to function properly: System Preference Name System Preference Value CL - Milestone Alert Days Configuring Email Alerts for Upcoming Milestones and", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PowerTrials", "definition": "To set up integration between CTMS and PowerTrials system (for ENU customers), perform the following tasks: 1. Enabling Integration Between CTMS and PowerTrials Update the domain address as shown below in Outbound Web Services. Note: This step is a prerequisite for enabling the integration between the CTMS and PowerTrials system. 2. Importing the PowerTrials Certificate to the CTMS Application 3.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Questions", "definition": "(Read-only) Displays the assessment question when you save the assessment template record. Administrators set up questions when they set up the template. 48", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Applications", "definition": "Modified topic. Information on supporting operation systems for disconnected mobile experience. What\u2019s New in Siebel Clinical Trial Management System Guide, Siebel CRM 23.3 Update The following table lists the changes in this revision of the documentation to support this release of the software.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "in Siebel Clinical", "definition": "Modified topic. Added the following user properties for Clinical Trip Report: \u2022 BIP Report Template Name \u2022 Enable FollowUp Activities for Approved TR \u2022 Enable FollowUp Activities with Status Not Equal To \u2022 Enable Question Number \u2022 Enable SmartScript Page Save \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Enable Unblinding", "definition": "What\u2019s New in Siebel Clinical Trial Management System Guide, Siebel CRM 23.1 Update The following table lists the changes in this revision of the documentation to support this release of the software.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Oracle Clinical One", "definition": "Integrating CTMS with Oracle Clinical One involves: \u2022 Setting up the User Access for REST APIs \u2022 Creating a Communication Profile 248", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical", "definition": "The following table describes the business component user properties that you can use to enable and configure functionality for Siebel Clinical.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "About Site Visit Name", "definition": "The site visit Name is user generated by default when you manually type in the name of the site visit during site visit creation. However, you can enable the site visit Name to be automatically generated. The following procedure shows how to enable the automatic generation of site visit Name by configuring the Calculate Site Visit Name user property in Siebel Tools. Once enabled, the site visit Name is automatically generated when you create a new site visit. To enable the automatic generation of site visit Name 1. Log in to Siebel Tools. 94", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Grouping Site Visits", "definition": "You can group site visits together according to the following categories: All Visits, Pending Visits, Pending Approval, and Closed Visits. \u2022 The All Visits category groups all site visits together irrespective of the Visit or Trip Report status. \u2022 All other categories group site visits according to various combinations of Visit and Trip Report status.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trip Reports", "definition": "The Approvals view provides a summary audit trail of the changes to the trip report status, including the dates and times of review and approval operations, and the details applicable to the users who complete those operations. To use audit trail for reviews and approvals of a clinical trip report 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report. The Trip Report form for the selected site visit appears. 3. Navigate to the Approvals view. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "eTMF", "definition": "To set up integration between CTMS and eTMF, perform the following tasks: 1. Enabling Integration Between CTMS and eTMF Integrating Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports is a prerequisite to this step. 2. Configuring Email Recipients 3. Configuring the LS Clinical Trip Report File Transfer Web Service 4. (Optional) Manually Generating Trip Report Files 242", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "for Clinical Trials", "definition": "Supporting Blinded and Unblinded Users for Clinical", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Overview of Siebel Clinical Trial Management System", "definition": "This guide documents Siebel Life Sciences with the optional modules installed. In addition, the Sample database includes data for optional modules. If your installation does not include some of these modules, then your software interface differs from that described in some sections of this guide. The exact configuration of Siebel Life Sciences screens and views depends on your company\u2019s configuration of Siebel Life Sciences. For more information about Siebel Life Sciences, see Siebel Life Sciences Guide . For introductory information about using the Siebel Life Sciences interface, see Siebel Fundamentals . Note: The Siebel Bookshelf is available on Oracle Technology Network (http://www.oracle.com/technetwork/ indexes/documentation/index.html) and Oracle Software Delivery Cloud. It might also be installed locally on your intranet or on a network location. 9", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Management System", "definition": "Overview of Siebel Clinical Trial Management System This chapter provides an overview of Oracle\u2019s Siebel Clinical Trial Management System. It includes the following topics: \u2022 About Siebel Clinical Trial Management System \u2022 Features of Siebel Clinical Trial Management System \u2022 Product Modules and Options for Siebel Clinical Trial System About Siebel Clinical Trial Management System Siebel Clinical Trial Managements System allows biotechnology companies, pharmaceutical companies, and CROs (clinical research organizations) to better manage the clinical trial process, maintain quality of clinical trials, and manage investigator relationships. It provides a comprehensive set of tools for CRAs (clinical research associates), clinical investigators, and site coordinators, and includes a personalized Internet portal to conduct study activities more efficiently. The following products are supported: \u2022 Siebel Clinical Trial Management System \u2022 Siebel Clinical Trial Management System Cloud Service Features of Siebel Clinical Trial Management System Siebel Clinical supports the following functionality: \u2022 Support for full clinical trial hierarchies of Subject-Site-Region-Protocol-Program \u2022 Support for global trials running in multiple countries, multiple languages, and multiple currencies \u2022 Support for randomized trials \u2022 Support for multi-arm, epoch, and adaptive trials \u2022 Site management tools for CRAs (clinical research associates), including a site calendar, trip reports, document tracking, and payment generation \u2022 Personalized Internet portal to help site coordinators, clinical investigators, and CRAs better manage clinical", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "trials over the Web", "definition": "\u2022 Project and resource management \u2022 A flexible audit trail engine 7", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "System", "definition": "N/A N/A Viewing Universal Inbox Notifications for Action Items of", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Setting Up Siebel Clinical", "definition": "5. In the Integration Object Map list, query for Clinical*Position*. 20", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Siebel Life Sciences", "definition": "\u2022 Activating workflows for accounts", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contacts", "definition": "Use this view to maintain a list of contacts associated with the project. Enter names of employees in subcontracting or partner organizations.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "accounts contacts", "definition": "\u2022 Generating column maps for accounts", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "contacts list", "definition": "\u2022 Creating product data to appear in accounts contacts list Siebel Life Sciences Guide Creating a clinical program \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Revising protocols", "definition": "\u2022 (Optional) Setting up regions \u2022 Defining a subject visit template Setting Up Clinical Trials Administering Clinical Subjects and Clinical", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visits", "definition": "Site visit data integration SWI LS Clinical Subject Inbound - Activity Clinical data management system integration 280", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Managing sites", "definition": "\u2022 Creating protocol site templates \u2022 Creating assessment templates for", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "contacts and accounts", "definition": "\u2022 Maintaining contact and account", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "information", "definition": "\u2022 Setting up contracts for sites Managing Sites and Contacts for Clinical", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trials", "definition": "This chapter describes blinded and unblinded support in Siebel Clinical, how to control access to data for blinded and unblinded users, and how to administer blinded and unblinded users for clinical trials. It includes the following topics: \u2022 What is a Blinded and Unblinded Clinical Trial? \u2022 Blinded and Unblinded Support in Siebel Clinical \u2022 Controlling Access to Data for Blinded and Unblinded Users \u2022 Site Management for Blinded and Unblinded Users \u2022 Inheritance Hierarchy for Blinded and Unblinded Users \u2022 Blinded and Unblinded Support in Siebel Mobile Disconnected Applications \u2022 Blinded and Unblinded Customization Support Note: This feature is available in Siebel CRM 20.7 Update and later releases. What is a Blinded and Unblinded Clinical Trial? A blinded clinical trial is one where participants do not know which treatment or medical intervention they have been allocated. In a blind clinical trial, certain information which may influence the participants in the trial (including subjects, CRAs, and evaluators) is withheld or hidden (blinded) until after the trial is complete. Good blinding can reduce or eliminate experimental biases that arise from participant expectation, observer bias, confirmation bias, and so on. An unblinded clinical trial is one where information is not withheld from trial participants and, in such cases, both participants and researchers know which treatment is being administered. During the course of a clinical trial, a participant becomes unblinded if they obtain information that has been withheld or hidden (blinded) from them. However, if this occurs unintentionally before the end of the trial, then this can be a source of experimental error. Blinded and Unblinded Support in Siebel Clinical Siebel Clinical provides the option to have and the ability to manage both blinded and unblinded users for clinical trials in Siebel CRM 20.7 Update and later releases. 203", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "projects", "definition": "\u2022 Creating activity templates for projects Managing Clinical Projects", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Importing data", "definition": "\u2022 Importing data with Siebel Enterprise", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Integration Manager", "definition": "\u2022 Importing, extracting, and routing", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "syndicated data", "definition": "\u2022 Charting denormalized syndicated data Siebel Life Sciences Guide Configuring Siebel Clinical \u2022 Configuring user properties for business", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "components", "definition": "\u2022 Configuring user properties for business", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "services", "definition": "\u2022 Configuring applet properties \u2022 Configuring field properties \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Configuring workflows", "definition": "Developer\u2019s Reference for Siebel Clinical 15", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "For More Information", "definition": "\u2022 Customizing Web services About the My Team\u2019s Filter The visibility filter appears on many screens. It provides a list of filters, such as My Contacts, My Team\u2019s Contacts, and All Contacts. These filters determine the records that appear in the view. The behavior of the My Team\u2019s filter varies from screen to screen. In some screens, this filter displays those records where the primary member of the team reports to the user. In other screens, this filter displays records where any of the team members report to the user. The Manager List Mode user property in the business component determines this behavior. If the Manager List Mode user property is active and set to Team, then the My Team\u2019s filter displays all records where the user\u2019s subordinate is on the team but is not necessarily the primary member. The following information lists the default setting of the Manager List Mode user property for some Siebel Clinical screens and business components.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Active", "definition": "\u2022 Cannot delete Sheet version \u2022 New charge sheet items can be added \u2022 Restricted update to following fields: \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Account", "definition": "\u2022 Initiation completed date \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Account Brick", "definition": "The source table for Account Brick is changed to S_CON_ADDR, and the source column for Account Brick is changed to BRICK_ID.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contact", "definition": "\u2022 Contact Medical Specialty Code \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contact Zip Code", "definition": "\u2022 Contact City State Country \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Position", "definition": "Contact Assignments in Siebel Clinical In most Siebel Business Applications, contact assignment is based on the primary address. This process is different for Siebel Life Sciences. A contact in Siebel Life Sciences can have multiple addresses, and each representative on the 17", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "File", "definition": "Complete the procedure in this topic to export DTE data maps from the server database to an XML file. To export DTE data maps from the server database to an XML file 1. In Siebel Clinical, connect to the server database. 2. Navigate to the Administration - Integration screen, then the Data Maps view. 3. In the Integration Object Map list, query for Clinical*. The query returns the following records: Clinical Region Position to Protocol Position Map, Clinical Site Position to Account Position Map, Clinical Site Position to Protocol Position Map, and Clinical Site Position to Region Position Map. 4. Click Menu (the cogwheel icon), and select Export Data Map. 5. In the dialog box, check Export All Rows in Current Query and click Export. 6. In the dialog box, select Save to Disk, select a location, and save the data maps as PositionRollupDataMap.xml. Importing DTE Data Maps to a Local Client From an XML File Complete the procedure in this topic to import DTE data maps to a local client from an XML file. To import DTE data maps to a local client from an XML file 1. In Siebel Clinical, connect to the local client. 2. Navigate to the Administration - Integration screen, then the Data Maps view. 3. In the Integration Object Map list, click Menu (the cogwheel icon), and select Import Data Map. 4. In the dialog box, select Browse and find PositionRollupDataMap.xml. For information about creating this file, see Exporting DTE Data Maps From the Server Database to an XML File. 19", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Setting Up Clinical Trials", "definition": "3. In the Assessment Templates list, create a new record and complete the necessary fields. Some fields are shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "End-User Procedures", "definition": "The following list shows the tasks end users typically perform to manage clinical projects: \u2022 Creating Clinical Projects. You associate protocols with projects. \u2022 Associating People and Accounts with Clinical Projects. Give employees access to the project; add contacts and accounts to the project team workbook. \u2022 Creating Activities and Tasks for Clinical Projects. Standalone activities are not associated with tasks. \u2022 Monitoring Costs for Clinical Projects. View costs for clinical projects. \u2022 Managing Risk for Clinical Projects. Document project risks and resolution activities. Creating Activity Templates for Clinical Projects You can create activities in the Projects screen. If the study managers primarily enter activities in the Projects screen, then creating activity templates for projects is advantageous. To create an activity template for projects, you create an activity template with a Project type. The Protocol Type field is optional because you can apply the activity template to any project, regardless of the protocol associated with the project. In the Activity Template Details list, create records to describe activities and milestones for the project. For information about how to create activity templates, see Siebel Applications Administration Guide . This task is a step in Process of Managing Clinical Projects. Setting Up Employee Profiles for Clinical Projects End users can use Siebel Assignment Manager to automatically search the employee database for the available employees whose skills best fit the needs of the project. Siebel Assignment Manager requires that you set up profiles of skills and competencies for employees. For information about using Siebel Assignment Manager, see Siebel Assignment Manager Administration Guide . Use of Siebel Assignment Manager is not required. End users can assign team members directly into the Team Workbook view, without using Siebel Assignment Manager. This task is a step in Process of Managing Clinical Projects. Setting Up Position Types and Rate Lists for Billing If project team members bill their time to the project through the Team Workbook view, then set position types and rate lists. 167", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Program", "definition": "Select the name of the program for the clinical trial.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Mechanism", "definition": "Select the partners associated with the clinical program.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Application", "definition": "Select a record containing details of the application for the clinical program. If necessary, create an application record. This record contains values for the following fields: Number. The number assigned to the application when it is submitted to the regulatory agency, for example the (A)NDA or IND number. Type. The type of application, such as CTN, IND, or CTX. Sub-Type. The application filer, for example, a company or an investigator. Filed. Whether the application is filed with the specified regulatory agency. Product. The applicable product for the application. You must complete this field before you can create a protocol for the program. Indication. The clinical indication for the application. 3. (Optional) Drill down on the Program field of the new record and associate files with the clinical program. 24", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Favorite", "definition": "Select this field and then select the star icon that appears to indicate that this site is a favorite. Deselect the star icon to remove the star icon from the Favorite field. A star icon appears in the Favorite field of each favorite site. Favorite sites appear first in the Protocol Site List.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Title", "definition": "Type a descriptive title for the protocol. 4. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 5. If required, click Cancel at any time to cancel the task. 6. Click Submit to submit the task - that is, create the new protocol. Creating Protocols and Regions The following procedure shows how to create a protocol and region using Siebel Clinical task-based UI. To create a protocol and region 1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical. 2. Click Create Protocol in the Task Pane applet. 3. Enter protocol data on the page that appears: \u25e6 Fields to complete are described in Creating Protocols. \u25e6 Select the Regions Required check box. 4. Click Submit. 5. Click Yes when prompted with the following question: Do you want to create Region now? 6. Click Submit. 192", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Status", "definition": "About Integrating Data for Activity Completion Oracle Health Sciences InForm controls the integration of activity completion data between Siebel Clinical and Oracle Health Sciences InForm. In Oracle Health Sciences InForm, when patient data is entered that complies with the criteria for the clinical item value for a visit or activity, Siebel Clinical receives a message containing a completion date. The visit or activity is updated with the status of Complete, and the completion date is populated. If the message from Oracle Health Sciences InForm does not contain a completion date, and the visit or activity in Siebel Clinical already has a status of Complete, then no change is made to the completion date or status in Siebel Clinical. Oracle Health Sciences InForm integrates activity completion data with Siebel Clinical as follows: \u2022 Siebel Clinical searches for the subject using the unique subject identifier (row ID). When the subject is found, it searches for the activity as follows: \u25e6 Siebel Clinical searches for the activity using the clinical item for the visit and the clinical item for the visit activity as follows: - If the clinical item in the update corresponds to a subject visit, then the completed date for that visit is updated. - If the clinical item in the update corresponds to an activity for a subject visit, then the completed date for that activity is updated. \u25e6 If the clinical item sent from Oracle Health Sciences InForm cannot be mapped to an activity completion item in Siebel Clinical, then an error is generated to indicate that the update failed. 219", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Product", "definition": "Select the product for the clinical trial. You can select only the products that are associated with the clinical program. # Planned Sites Type the number of planned sites for the protocol. 191", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Phase", "definition": "Select the phase of clinical trial, such as, Phase I, II, or III.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Objective", "definition": "Type the objective for the clinical trial.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sponsor", "definition": "Select the clinical trial sponsor.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Design", "definition": "Select the type of study. 25", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Regions Required", "definition": "Select this check box only if the sites for the protocol must belong to a region (and see Creating Protocols and Regions for more information). When you select this check box, you cannot create sites directly under protocols. You must create regions first, and then create sites that are associated with regions. Deselect this check box to indicate that the sites for this protocol must not belong to a region. Protocol # Type an identifying number for the protocol.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Type", "definition": "Select the purpose of the protocol.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Team", "definition": "Read-only field. The team for the satellite site, inherited from the parent site. For more information, see Creating Sites for Clinical Trials (Step 3.). 6. Drill down on the Satellite Site Number field to complete more fields as necessary. Some data is inherited from the parent site and cannot be changed. Some fields are shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Approval Date", "definition": "Select the date that the regulatory authority approves the protocol.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Currency Code", "definition": "Select the currency that will be used to display the payments, costs, and budgets for the region. The default value is USD (US dollars).", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Planned Start Date", "definition": "Select the planned start date for the study.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Exchange Date", "definition": "Select the date that determines the exchange rate of the currency. By default, the exchange date for the region is the date that you create the region.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Planned End Date", "definition": "Select the planned end date for the study.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Withholding Amount", "definition": "Type the amount to withhold from each of the payments to the investigators until the trial completes. Withholding Percent (%) Type the percentage to withhold from each of the payments to investigators until the trial is complete.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Actual Start Date", "definition": "Select the date that the study begins. # Planned Sites Type the number of planned sites for the protocol. # Planned Subjects Type the number of planned subjects for the protocol. Withholding % Type the percentage to withhold from each of the payments to the investigators until the trial is complete. You can overwrite this value at the region and site levels.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Actual End Date", "definition": "Select the date that the study concludes. 26", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Comments", "definition": "\u25e6 Active flag (on Charge Sheet Items)", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Central Lab", "definition": "Select the name of the laboratory associated with the study. You create this name in the Accounts screen.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CRO", "definition": "Select the Account name to assign the associated CRO. # Planned Sites Type the number of planned sites for the region. # Planned Subjects Type the number of planned subjects for the region.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Role", "definition": "The role of the contact.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Start Date", "definition": "The date when the contact record is active.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "End Date", "definition": "Displays the date that the contact record is archived. Adding Address Types for Sites Users can add a specific type of addresses for each site. This task is a step in Process of Managing Sites and Contacts for Clinical Trials. To add an address type for a site 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to add an address type. 3. Navigate to the Addresses view. 99", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Lock Record", "definition": "Select this field to make the record read-only and to make the End Date field a required field. Automatically Assigning Team Members to a Protocol Using the Position Rolldown Button When you add a team member to a protocol, click the Position Rolldown button to add the member to all regions and all sites under the protocol. You can add a member to the team only once. When you click the Position Rolldown button to add a member to the team of a protocol, a record is created, where applicable, in each of the Team History views for all regions and all sites belonging to the protocol. The Position Rolldown mechanism automates the addition of team members to the Team History view for sites and the Team History view for regions as if they are manually added. About Removing Team Members From the Team of a Protocol When you remove a team member from the protocol, the team member is removed from either the protocol, or from all protocols, regions and sites belonging to the protocol. When you remove a member from the team of a protocol (either manually or through Position Rollup or Position Rolldown), the End Date field of the team member\u2019s record, if present, is updated with the system date. However, if 28", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Original Version", "definition": "Select this field if this version is the first version of the protocol. If this field is checked, then the Amendment Version field is read-only.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Amendment Version", "definition": "Select the version number of the protocol version, for example, Version 1, Version 2, and so on.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Date", "definition": "Displays the timestamp of the change.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Central IRB", "definition": "Select this field to indicate that all sites use a central institutional review board.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Regional CRO", "definition": "Select this field to indicate that a clinical research organization provides services to all sites in the clinical region. Creating Accounts and Contacts for Clinical Trials An account is the institution from which you manage clinical trials. Typically, it is the facility where the investigators conduct the trials. You can track as accounts IRBs (institutional review boards), central laboratories, CROs (clinical research organizations), and other subcontractors. You can associate multiple sites with an account, and an account can carry out multiple protocols. A contact is a person working at a clinical site. Contacts include investigators, typically medical professionals who are also researchers, and site coordinators, who might be the practicing nurses administering the treatment plan according to the clinical protocol. 33", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Region", "definition": "The geographical region to which the site belongs. Principal Investigator The principal investigator for the site (contact associated with the site).", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocol Region", "definition": "Displays the name of the region. This field is automatically populated with the protocol number and region name.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "No Site Info", "definition": "Select this option to indicate that no site information will be available under the region. In such cases, only summary information about site enrolment will be available for the region. Deselect this option to indicate that site information will be available under the region. 8. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 9. If required, click Cancel at any time to cancel the task. 10. Click Submit to submit the task - that is, create the new protocol and region. 193", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "and Rolldown Buttons", "definition": "When you click the Position Rolldown and Position Rollup button, a record is created, where applicable, in each of the Team History views for the protocol and all sites belonging to the region. The Position Rolldown mechanism automates the addition of team members to the Team History view for sites and the Team History view for protocols as if they are manually added. To remove a team member from the protocol, see About Removing Team Members From the Team of a Protocol. Creating Assignment Team History for Regions The Team History view allows you to administer and track team members who work in the region. It also provides details about the roles as well as the start and end dates. To create assignment team history for a region 1. Navigate to the Administration - Clinical screen, then the Region List view. 2. In the Region list, drill down on the Region field of the region for which you want to create a new team assignment history. 3. Navigate to the Team History view. 4. In the History list, create a new record and complete the necessary fields. 32", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Creating Accounts", "definition": "Complete the procedure in this topic to create an account.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "To create an account", "definition": "1. Navigate to the Accounts screen, then the Accounts List view. 2. In the Accounts list, create a new record and complete the necessary fields. Some fields are shown in the following table. To access more fields, click the show more button in the account form.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Site", "definition": "The site associated with the trip report file.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Account Type", "definition": "Select the type of account, such as Hospital, Clinic, IRB, and so on.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Account Team", "definition": "Select the members assigned to the account team. The team member who creates the account record is the primary team member.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Address", "definition": "The address for the contact.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Synonyms", "definition": "Select the synonyms for the account. This field allows you to refer to accounts in the way that you prefer. For example, an account named A/B Products, Inc., might have the following synonyms: AB, A/B, and AB Products. When you search for an account or enter an account in another part of your Siebel Business Application, you can use a synonym instead of the actual name.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Territories", "definition": "Select the territories that are associated with the account. 34", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "My Address", "definition": "Select the addresses for the contact. A contact can have more than one address. You must specify one address as the primary address. Each CRA (clinical research associate) assigned to the contact can specify a different address as the primary address. For example, one CRA might specify a private office as the primary address, while another CRA might specify a hospital department as the primary address.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Satellite Site", "definition": "Read-Only field. A star in this field indicates that this is a satellite site. Site # Type the number to assign to the site. This field is not required when the Status field for the site is Planned or Not Initiated. This field becomes required after a site is initiated. Protocol # Select the protocol from the list of existing protocols in the Pick Protocol dialog box.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Parent Site", "definition": "Read-only field. The parent site for the satellite site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PI Last Name", "definition": "Select the last name of the principal investigator for the site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "No Subject Info", "definition": "Select this field to indicate that no subject information is available for a site. Only summary information about subject enrollment is available for such a site. 36", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Versions", "definition": "Read-only field.The version of the subject visit template, which is inherited from the parent site. Only one version can be active at a time. The active template is used when activities are generated for a subject. For more information about protocol versions, see Tracking and Revising Team Assignment History", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contract Amount", "definition": "Type the amount of money that the contract is worth. If you enter multiple contracts, then the total value of all contract amounts equals the total contract amount for the site. This total appears in the Contract Amount field on the site form.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Paid To Date", "definition": "Displays the amount of money that you paid to date to the investigators.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Earned To Date", "definition": "The amount of money that investigators earned to date. Activate for Synchronization Select this field to activate the site for synchronization. This field is required for integration with Oracle Health Sciences InForm. When this field is checked, a new integration object for the protocol site is sent to Oracle Health Sciences InForm. The integration object creates the site in Oracle Health Sciences InForm, or updates the site, if it already exists. This field is read-only until the following conditions are met: \u25e6 The Synchronize Active Study Sites field of the protocol is set to true. \u25e6 The Primary Site Address field is populated.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Primary Site Address", "definition": "Select the primary address for the site. This field sets the primary location of the site for the study in Siebel Clinical. The Addresses dialog box displays all addresses for the site. This field is required for integration with Oracle Health Sciences InForm, and populates the site address when the site is created in Oracle Health Sciences InForm. 42", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Satellite Site Number", "definition": "Type the number to assign to the satellite site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PI First Name", "definition": "The first name of the principal investigator for the site (read-only field). # Planned Subjects Type the number of planned subjects for the protocol.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Site Initiated", "definition": "The date the satellite site was created. This field is blank by default.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Site Terminated", "definition": "The date the satellite site was terminated. This field is blank by default. 40", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Satellite Site Count", "definition": "Displays the number of satellite sites associated with this site. 8. Assign subject visits to the satellite site as follows: a. Navigate to the Subjects view. b. Create a new Subject record and complete the necessary fields. c. Drill down on the Screening # field. d. Create a new Visit Plan record and complete the necessary fields. Some fields are shown in the following table. For more information about subjects visits, see Defining Subject Visits.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Assigned To", "definition": "Select the users assigned to the trip report. The team member who creates the trip report is the primary owner.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sequence", "definition": "Type the sequence number of the visit. Typically, the first visit has a sequence number of 1.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Name", "definition": "Type the name of the version of the training plan.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Region", "definition": "Clinical Remove Position From Site", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Assessment", "definition": "Type in the name of the template.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Protocol", "definition": "SWI LS Clinical Create Site Visit Geo", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Order", "definition": "(Read-only) Displays the order number for the question when you save the assessment template record. Administrators set up the order number for each question when they set up the template.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Category", "definition": "Select the type of training applicable to the training topic.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Technology", "definition": "\u25e6 Data Collection, CRF source \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Endpoints", "definition": "\u25e6 Organization Experience \u25e6 Investigational Product/Study Medication \u25e6 IP Logistics/Supply Chain \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Weight", "definition": "(Read-only) Displays the weight for the attribute when you save the assessment template record. Administrators set up the weight for each attribute when they set up the template. This field is essentially ranks the importance of the category. If all categories have a default value of 1.0, then all categories are of equal importance.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Considerations", "definition": "Type in any additional information relevant to the assessment question that should also be considered. Any information that you enter in this field automatically appears on screen (for example, as a tool tip) when the user places the mouse over the respective question during an assessment. 4. In the Question Values list, create records to further describe the assessment questions you created in the previous step, and complete the necessary fields as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Value", "definition": "Select the value that applies to the option that you select in the Type field. For Impact and Probability, the values available are: \u25e6 High (3) \u25e6 Medium (2) \u25e6 Low (1) For Detectability, the values available are: \u25e6 Difficult to detect 3) \u25e6 Medium to detect (2) \u25e6 Easy to detect (1)", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Score", "definition": "Displays the sum of the Weight field multiplied by the Score field for the assessment attributes that are associated with the template. This field is populated after you assign values to assessment attributes.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Template Name", "definition": "Select a template that includes the appropriate attributes to assess the program, protocol, region, or site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Updated", "definition": "Displays the date and time that the field was modified. 160", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Percent", "definition": "Displays as a percentage the result of the Score field for the template divided by the Maximum Score field for the template. This field is populated after you assign values to assessment attributes.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Maximum Score", "definition": "Displays the highest score possible for the template that you select. For each assessment attribute in the template, the Weight field is multiplied by the highest value possible in the Score field. The sum of these results is the maximum score for the template. 4. In the Assessment Questions list, enter a value for each question to assess the program, protocol, region, or site in the clinical trial. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Impact", "definition": "Select an impact value for the question, which can be one of the following: \u25e6 High (3) \u25e6 Medium (2) \u25e6 Low (1) This value determines the impact of the individual risk on the trial.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Probability", "definition": "Select a probability value for the question, which can be one of the following: \u25e6 High (3) \u25e6 Medium (2) \u25e6 Low (1) This value determines the probability of occurrence of the individual risk.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Detectability", "definition": "Select a detectability value for the question, which can be one of the following: \u25e6 Difficult to detect 3) \u25e6 Medium to detect (2) \u25e6 Easy to detect (1) The higher the detectability of individual risk, the lower the overall risk to the trial", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Risk Score", "definition": "(Read-only) Displays the risk assessment score for the individual question. Individual risk scores are calculated automatically from the values in the following fields: Impact, Probability, Detectability, Weight. The default formula for calculating individual risk score is product of Impact, Probability, Detectability and Weight.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Risk Level", "definition": "Select a value that specifies the type of risk assessment template, which can be one of the following: \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rationale", "definition": "If required, type in any explanatory information to capture the rationale for category risk level assessment. 49", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Functional Impact", "definition": "Select a functional impact value for the attribute, which can be one of the following: \u25e6 Medical Monitoring Plan \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data Plan", "definition": "\u25e6 Statistical Analysis Plan \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Communication Plan", "definition": "This field highlights the specific functional plans that might be impacted by this assessment.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Mitigation", "definition": "If required, type in the mitigation actions or plans for categories with the highest category risk score. 50", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Administering Clinical Subjects and Clinical Visits", "definition": "To monitor status accruals for clinical subjects by visit type 1. Navigate to the Protocols, Regions, or Site Management screen. 2. In the list, select the record for which you want to create the charts. 3. Navigate to the Charts view. 4. Select values from the drop-down lists as follows: a. From the first drop-down list, select Subject Status Analysis. b. From the second drop-down list, select Subject Accruals. c. From the third drop-down list, select the time frame. d. From the fourth drop-down list, select the display type, such as bar chart or pie chart. 5. Click Go. Using Audit Trail for Changes to Subject Status The Status Audit Trail view provides a detailed history of the changes to Subject Status records, including the dates and times of the changes and details of the users who make the changes. To use the audit trail for changes to subject status 1. Navigate to the Subjects screen, then the Subject List view. 2. In the Subject list, drill down on the screening number field of the subject. 3. Navigate to the Status Audit Trail view. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Version", "definition": "The version number of the trip report.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Obsolete", "definition": "When you create a new version of the subject visit template, the Status field is populated with a value of In Progress.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Change Summary", "definition": "Type a summary of changes to the version of the subject visit template. Defining Subject Visits This topic describes how to define subject visits in a subject visit template. 53", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit Type", "definition": "The type of site visit.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "End of Study", "definition": "You can add, modify, or delete values for the Visit Type field.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Planned", "definition": "Select this field to define a subject visit as a planned visit. This field is selected by default.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Status Tracking Visit", "definition": "Select this field to enable automatic tracking of the status in the Subject Status MVG (multi value group) for each visit type. You can set only one visit as the status tracking visit for each visit type. For example, if TreatmentPhase1, TreatmentPhase2, and TreatmentPhase3 clinical visits exist for a Treatment visit type, then you can set only TreatmentPhase3 as the status tracking visit. When you select the Status Tracking Visit field for a visit, the following status records are automatically created in the Subject Status MVG when each predefined visit type is processed: \u25e6 A Visit Type value of Screening creates a Screened status record in the Subject Status MVG. \u25e6 A Visit Type value of Re-Screening creates a Re-screened status record in the Subject Status MVG. \u25e6 A Visit Type value of Enrollment creates an Enrolled status record in the Subject Status MVG. \u25e6 A Visit Type value of End of Study creates a Completed status record in the Subject Status MVG. You can manually override the automatic value in the Subject Status MVG. Any create, update, or delete operations on the tracked status fields trigger automatic create, update, and delete operations in the Subject Status MVG. Automatic status tracking is not enabled for custom values in the Visit Type list. 54", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Lead", "definition": "Type the lead time from the start date. You define the start date in the Schedule Date field when scheduling the subject.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Lead Units", "definition": "Select the units for the lead time.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Min", "definition": "Type the time before the lead time that the visit can occur. For example, if Min is 1 and Min/Max Units is days, then the visit can occur one day before the scheduled date. Do not leave this field empty.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Max", "definition": "Type the time after the lead time that the visit can occur. For example, if Max is 2 and Min/Max Units is days, then the visit can occur up to two days after the scheduled visit. Do not leave this field empty. Min/Max Units Select the units for the Min and Max values. Do not leave this field empty. # CRF Pages Type the number of CRF (case report form) pages.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Withdrawn", "definition": "The Subject record automatically updates as follows: \u2022 A record with a Status field value of Withdrawn is added to the Subject Status MVG, and the value in the Withdrawn Date field is copied to the Date field of the Subject Status MVG. \u2022 The Status field is updated to Withdrawn. When a Screen Failure or Early Terminated event occurs, all remaining visits for the subject are deleted. For more information, see the LS Subject Terminate Study Status Value 1 user property in User Properties for Business Components in Siebel Clinical. Applying Protocol Amendments to Sites and Clinical", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Duration", "definition": "Type an estimate of the numeric value for the time that is needed to complete the training topic. 176", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Payment Flag", "definition": "Select this field to indicate that you pay the investigator for this activity. This flag is selected by default. For more information about payments, see Setting Up and Making Clinical Payments 56", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Payment Amount", "definition": "Type the standard amount that you pay the investigator for this activity. You can adjust this amount for each site or each individual. Approving Subject Visit Templates Setting the status of a subject visit template to approved sets the subject visit template as read-only. You can modify only the Approved Date field of an approved subject visit template. To approve a clinical subject visit template 1. Navigate to the Administration - Clinical screen, then the Visit Templates view. 2. In the Template Versions list, select the version of the template to approve. 3. Enter the date in the Approval Date field. 4. Select Approved in the Status field. About Automatic Tracking of Subject Status This topic describes the fields that the mechanism for automatically tracking subject status uses, and the automatic operations that they trigger in the Subject Status MVG (multi value group). The Subject Status MVG contains a history of the subject\u2019s status. It contains the following fields. \u2022 Date. The date that users change or update the status. \u2022 Status. The status of the subject, for example, Screened, Enrolled, or Re-screened. \u2022 Primary. A flag that sets the current status. This field appears in the Status field of the Subjects view. \u2022 Comments. Comments about the subject status. \u2022 Visit Type. The type of clinical subject visit, such as Screening or Enrollment. This field is null for status records, such as Randomized and Withdrawn. Status Tracking Fields that Trigger Create and Delete Operations on Records in Subject Status MVG The following table lists the status tracking fields that trigger create and delete operations on the records in the Subject Status MVG. The records in the Subject Status MVG are automatically updated as follows: \u2022 Populating a status tracking field listed in the following table automatically creates the corresponding status record in the Subject Status MVG, including Status, Date, and Visit Type fields, where applicable \u2022 Deleting a status tracking field listed in the following table automatically deletes the entire corresponding status record in the Subject Status MVG, including the Status, Date, and Visit Type fields, where applicable. 57", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Status Tracking Field", "definition": "Field of Subject Status MVG Automatically Updated Creating Records for Clinical Subjects CRAs (clinical research associates) can enter information about clinical subjects. When they create the subject record, the subject visit template that is active for the site is used to set up a schedule of visits and activities for the subject. To create a record for a clinical subject 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site to which you want to add a subject. 3. Navigate to the Subjects view. 4. In the Subjects list, create a new record and complete the necessary fields. Some fields are shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Completed", "definition": "The end user completed the trip report, and it is ready for the end user to submit for review.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Override Status", "definition": "Status field in the Subject Status MVG is updated to Missed, or the status value in the Visit Plans list for that visit. 58", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subject Status MVG", "definition": "The following table lists the status tracking fields that trigger update operations on the Date and Status fields of the Subject Status MVG. The fields of the Subject Status MVG are automatically updated as follows: \u2022 Populating or updating a status tracking field listed in the following table automatically triggers an update to the corresponding Date or Status field value in the Subject Status MVG. \u2022 Deleting a status tracking field listed in the following table automatically triggers a delete operation on the corresponding Date or Status field value in the Subject Status MVG.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Randomized Date", "definition": "Select the date that you randomize the subject into an arm of the trial. 6. Save the record. The Subject record automatically updates as follows: \u25e6 A Randomized status record is added to the Subject Status MVG (multi value group), and the value in the Randomized Date field is copied to the Date field of the Subject Status MVG. \u25e6 The Status field is updated to Randomized. Overriding Initial Subject Status You can override the initial subject status for a status tracking clinical visit by selecting a new status in the Override Status field. For example, for a status tracking clinical visit with a Missed value, you can subsequently set the Override Status field to Completed. 65", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screen Failure Date", "definition": "Displays the date that the subject fails screening. 5. Click Schedule. The Schedule applet is launched. 6. Select a date in the Schedule Date field, and click OK. The subject visits record updates as follows: \u25e6 All the visits in the active subject visit template are copied to the Visit Plans list. \u25e6 The Visit Type, Name, Start Date, Planned, Status Tracking Visit, and Status fields are copied from the subject visit template. \u25e6 The planned dates and due dates are calculated using the lead time in the subject visit template and the start date in the Schedule Date field. The planned dates and due dates are calculated as follows: planned or due date equals schedule date plus lead time. Note: You can also schedule subjects through workflows. Set the Enroll Screen Rescreen Through WorkFlow user property to true to execute the schedule subject tasks in workflows instead of executing these tasks through applets and business component methods. If the Enroll Screen Rescreen Through WorkFlow user property is set to true, then workflows in other user properties are executed according to context. You can change workflow names to execute custom workflows. You can also modify other workflows and business service methods according to your needs. For more information about the Enroll Screen Rescreen Through WorkFlow user property, see User Properties for Business Components in Siebel Clinical. 61", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Withdrawn Date", "definition": "Displays the date that the subject withdraws from the clinical trial.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Early Terminated Date", "definition": "Displays the date that the subject\u2019s participation in the trial terminates.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Completed Date", "definition": "Select the resolution date and time of the follow-up issue. You must populate this field because the filter in the All Follow-Up Items list uses this date to determine the closed follow-up items to show. 6. Set the Trip Report Status field to Submitted. The report is submitted to the reviewer for review. Completing Questionnaires for Clinical Trip Reports This topic describes how to complete a questionnaire for a clinical trip report. You launch the questionnaire in the SmartScript player from the Questions view of the trip report. Questions and responses along with comments (if any) are saved in the Questions list. To complete a questionnaire for a clinical trip report 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report. The Trip Report form for the selected site visit appears. 147", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subject ID", "definition": "Type a unique identifier for the subject.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Encounter Date", "definition": "Select the date that the subject first registers for the trial. Screening # Displays the screening number for the subject. This field is automatically generated from the Subject ID field and the Encounter Date field. The screening number is automatically generated after you enter the Subject ID field and the Encounter Date field, and save the record.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Enrollment ID", "definition": "Type the principal ID number for the subject.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Randomization ID", "definition": "Type an ID number for the subject, which you can use in randomized studies where both an enrollment ID and a randomization ID are required. Informed Consent Dates Select the date that the subject signs the informed consent form for participation in the clinical trial. You must obtain informed consent prior to initiation of any clinical screening procedures.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screen Failure Reason", "definition": "Select the reason the subject fails screening.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Withdrawn Reason", "definition": "Select the reason the subject withdraws from the clinical trial. Early Termination Reason Select the reason the subject\u2019s participation in the trial terminates early. The following values are available: \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Lost to Follow-Up", "definition": "\u25e6 Non-Compliance with Study Drug \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screen Failure", "definition": "The Subject record automatically updates as follows: 69", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Not Done", "definition": "Scheduling Clinical Subjects Scheduling a subject applies the activated subject visit template. You enter a single start date for all subject visit types in the Schedule Date field. 60", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Fixed Date", "definition": "The remaining subject visit dates are rescheduled using the date in the Reschedule applet. Last Completed Visit Date The remaining subject visit dates are rescheduled using the delay between Planed Date and Completed Date for the last completed visit. The rescheduled dates for the planned dates and due sates are calculated as follows: Planned or Due Date equals Planned Date or Due Date plus Delay Administering Subject Visits in Batch Mode The Visit Types view displays the subject visit plan by visit type. Each distinct visit type for the subject appears in the Visit Types applet, with a read-only field indicating whether or not each visit type is planned for the subject. Associated 62", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Random ID", "definition": "Type the ID number assigned to the subject for the randomized trial.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Missed", "definition": "5. For a completed visit, enter the completion date in the Completed Date field. Transferring Clinical Subjects The subject transfer feature allows you to manage the transfer of subjects from one study site to another, with options to retain the subject\u2019s visit data and also the destination study site\u2019s visit template. During subject transfers, the payment exceptions from the destination site are applied and the payment data is recalculated. A history of all subject transfers is tracked at the subject and the site level. To ensure more robust data audit trails, you can no longer delete subjects and sites. To transfer clinical subjects 1. Navigate to the Subjects screen, then the Subject List view. 2. In the Subject list, select the subject that you want to transfer. 3. Click Transfer to open the Transfer applet. 4. In the Transfer applet, complete the fields as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Informed Consent Date", "definition": "Select an informed consent date if prompted.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Scheduled Date", "definition": "The start date for the destination site\u2019s clinical subject visits.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Reason", "definition": "Select a reason for the subject transfer from the Reason drop-down list.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Transfer Date", "definition": "The date of the subject transfer. 5. If the destination site\u2019s Subject Visit Template version differs from the originating site, then you are prompted with a message similar to the following: Would you like to delete uncompleted visits from the old version and completed visits from the new version? Click OK to confirm the deletion of non applicable visits. After confirmation, the subject transfer process completes, new visits and payment exceptions are applied as defined by the destination site, and the transfer history for the subject and the site is updated accordingly. For more information, see Viewing Subject Transfer Information for Clinical Subjects and Sites. Viewing Subject Transfer Information for Clinical", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subjects and Sites", "definition": "The Transfer History and Subject Transfer History views show all the subject transfer information for subjects and sites respectively. To view subject transfer information for clinical subjects and sites 1. View the subject transfer information for a subject as follows: a. Navigate to the Site Management screen, then the Protocol Site List view. b. Drill down on the Site # field of the site that you want. c. Navigate to the Subjects view. d. Drill down on the Screening # field of the subject for which you want to view subject transfer information. The Visits view of the Subjects screen appears showing the Visit Plans. e. Navigate to the Transfer History view. The Transfer History view appears showing all subject transfers against the subject. The view includes the following information for each subject transfer: Source Site Name, Destination Site Name, Transfer Date, Transferred By, Status at Transfer, Description. 2. View the subject transfer information for a site as follows: a. Navigate to the Site Management screen, then the Protocol Site List view. b. Drill down on the Site # field of the site for which you want to view subject transfer information. c. Navigate to the Subject Transfer History view. The Subject Transfer History view appears showing all subject transfers against the site as follows: - The Subject In applet lists all subject visits transferred to the site. 67", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Done", "definition": "Select the date that the visit occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Done Flag", "definition": "Select this field to indicate that the visit occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Calendar Planned", "definition": "Select the date and time that the subject visit is due. This field value is automatically populated in the Due field.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Lock Assignment", "definition": "Lock the assignment as required by selecting this field. 4. If required, click the plus (+) icon to create additional activity plans. 5. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 6. If required, click Cancel at any time to cancel the task. 7. Click the check box next to each activity plan that you want to associate with the site and then click Submit to submit the task - that is, create the activity plan(s) for the site. Creating Activity Plans for Existing Protocols The following procedure shows how to create activity plans for existing protocols using Siebel Clinical task-based UI. To create an activity plan for an existing protocol 1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical. 2. Click Other Protocol Tasks in the Task Pane applet. 3. Select the record that you want in the Protocols list and then click Next. 4. Select Yes for Activity Plans and then click Next. 5. Enter activity plan details on the page that appears - all fields are described Creating Activity Plans for Sites. 6. If required, click the plus (+) icon to create additional activity plans. 7. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 8. If required, click Cancel at any time to cancel the task. 9. Click the check box next to each activity plan that you want to associate with the protocol and then click Submit to submit the task - that is, create the activity plan(s) for the protocol. Creating Activity Plans for Existing Regions 197", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Early Terminated", "definition": "You can track additional custom subject statuses by configuring additional values for this property type. This property takes the following comma-delimited list of parameters: \"[Business Component Field Name]\", \"[DateField]\", \"[Status Value\" \u2022 [Business Component Field Name] is the name of the business component field that is tracked for automatic status tracking, for example, Randomization ID. \u2022 [Date Field] is the name of the corresponding date field that is tracked for automatic status tracking, for example, Randomized Date. \u2022 [Status Value] is the corresponding status value that is tracked for automatic status tracking, for example, Randomized. Status Tracking Field 1", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subjects", "definition": "This topic describes how to set up PSDV (partial source data verification) for clinical subjects. You set up this verification by entering PSDV values in some fields when you create or update a record for a clinical subject. To set up partial source data verification for a clinical subject 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, create a new record and complete the necessary fields. For more information, see Creating Sites for Clinical Trials. Alternatively, you can select an existing site record. 3. In the Protocol Site list, drill down on the site number field of the site record. 4. Navigate to the Subjects view. 5. In the Subjects list, create a new record and complete the necessary fields as shown in the following table. For more information, see Creating Records for Clinical Subjects. Alternatively, you can select an existing subject record to update it.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Early Termination", "definition": "In addition to automatically deleting non-applicable visits for protocol amendments, visits that are scheduled and deemed non-applicable by early termination are deleted. Visits that are not scheduled through a template are not deleted. The following rules apply to deleting the appropriate visits: 1. Delete non-applicable, scheduled visits after a subject terminates the study. When the Status field of a subject is changed to Early Terminated and the Early Terminated date is populated, all future visits are deleted. Future visits are visits with a Due date and an Early Terminated date. 2. Delete non-applicable, scheduled visits after a subject fails screening. When the Status field of a subject is changed to Screen Failure and the Screen Failure date is populated, all future visits are deleted. Future visits are visits with a Due date and a Screen Failure date. About Rolling Up Information for Subject Enrollment Siebel Clinical supports clinical organizations in better managing subject enrollment for their trials in real-time. To implement this tracking, subject information is rolled up from the site level to the region level and then to the protocol level or directly from the site level to the protocol level. However, frequently this data is not available to the clinical organization, which presents significant business challenges. For example, if organizations out source trials to CROs (clinical research organizations), then the clinical organizations cannot always receive subject level information. The enhanced subject rollup functionality provides accurate subject enrollment data at the region and protocol level, when subject level information is not available for each site or region. Characteristics of Trials Where Subject Level Data is Available for", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Each Site", "definition": "Trials, for which subject level information is available for each site, display the following rollup characteristics: \u2022 Subject enrollment information is automatically rolled up from the subject level to the site level, from the subject level to the region level, and from the subject level to the protocol level. \u2022 When a subject is the first subject to enroll for a site, region, or protocol, the date in the First Subject Enrolled field for that site, region, or protocol, is automatically populated. 73", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "for Each Site", "definition": "Trials, for which subject level information is not available for a site, display the following characteristics: \u2022 You can select the No Subject Info field for sites that do not have subject level information. \u2022 CRAs (clinical research associates) can enter information in the following fields for sites that do not have subject or site level information: \u25e6 # Screened \u25e6 # Re-Screened \u25e6 # Screen Failure \u25e6 # Enrolled \u25e6 # Completed \u25e6 # Early Terminated \u25e6 First Subject Enrolled \u25e6 Last Subject Off Study \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Terminated Date", "definition": "\u25e6 First Site Initiated Date \u25e6 Last Site Terminated Date \u2022 Information that you manually for regions without site data is rolled up in the same manner as the information for regions with subject data. Viewing Status Accruals for Clinical Subjects of Sites Clinical subject data is automatically rolled up to the clinical site record. The Status Field RollUp user properties determine the criteria for the automatic rollup of subject status accruals to the clinical site record. For more information about these user properties, see User Properties for Business Components in Siebel Clinical. You must select the Status Tracking Visit field (in the Visits list in the Visit Templates view of the Administration - Clinical screen) to automatically create subject status accruals for pairs of a visit type value and a subject status value. For more information about the Status Tracking Visit field, see Defining Subject Visits. The task in this topic describes how to view subject status accruals for each visit type and subject status of a clinical site. To view status accruals for clinical subjects of a site 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to view subject accruals. 3. Navigate to the Subject Status Accruals view. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Total Accrual Number", "definition": "Displays the number of current and past subject status accruals that are automatically created for the site visit.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Regions", "definition": "The Payments view of the Regions screen is automatically populated with the existing payment records for the sites that are associated with the region. These payment records apply to the complete payment activities for those sites. In this view, you can generate payment records for complete, unpaid payment activities for the sites in the region. To generate payment records for sites associated with a clinical region 1. Navigate to the Regions screen, then the Region List view. 2. In the Region list, drill down on the Region field of the region for which you want to generate payment records for sites. 3. Navigate to the Payments view. If payment records exist in this view, then the selected payment record is irrelevant to this procedure. 4. Click Generate Payment. A dialog box of site records applicable to the region appears. Your system administrator can set the Popup Visibility Type property to configure the records that appear in this dialog box. For more information about this property, see Applet Properties in Siebel Clinical. 5. In the dialog box of site records applicable to the region, select the appropriate sites, and click OK. The complete payments are removed from the Payment Activities view in the Protocol Site List view of the Site Management screen. Payment records for each unique contract, account and payee combination are generated in the Payments view in the Protocol Site List view of the Site Management screen. You must again access the Payments view in the Region List view of the Regions screen to view the generated payments. For the protocol that is associated with the selected sites, the generated payments also appear in the Payments view in the Protocol List view of the Protocols screen. 6. (Optional) To access a notification containing details about the payment generation, click Notification on the menu toobar. Your system administrator can set the WF properties to configure notifications for bulk payments. For more information about these properties, see Applet Properties in Siebel Clinical. For more information about using notifications, see Siebel Fundamentals Guide . Generating Payment Records for Unplanned Payment", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocols", "definition": "The Payments view of the Protocols screen is automatically populated with the existing payment records for the sites that are associated with the protocol. These payment records apply to the complete payment activities for those sites. In this view, you can generate payment records for complete, unpaid payment activities for the sites in the protocol. To generate payment records for sites associated with a clinical protocol 1. Navigate to the Protocols screen, then the Protocol List view. 2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate payment records for sites. 3. Navigate to the Payments view. If payment records exist in this view, then the selected payment record is irrelevant to this procedure. 4. Click Generate Payment. A dialog box of site records applicable to the protocol appears. Your system administrator can set the Popup Visibility Type property to configure the records that appear in this dialog box. For more information about this property, see Applet Properties in Siebel Clinical. 5. In the dialog box of site records applicable to the protocol, select the appropriate sites, and click OK. The complete payments are removed from the Payment Activities view in the Protocol Site List view of the Site Management screen. Payment records for each unique contract, account and payee combination are generated in the Payments view in the Protocol Site List view of the Site Management screen. You must again access the Payments view in the Protocol List view of the Protocols screen to view the generated payments. For the region that is associated with the selected sites, the generated payments also appear in the Payments view in the Region List view of the Regions screen. 6. (Optional) To access a notification containing details about the payment generation, click Notification on the menu toobar. Your system administrator can set the WF properties to configure notifications for bulk payments. For more information about these properties, see Applet Properties in Siebel Clinical. For more information about using notifications, see Siebel Fundamentals Guide . 134", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Employee Login", "definition": "Displays the username of the user who changed the record.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Business Component", "definition": "Displays the business component for the record where the database change occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Field", "definition": "Displays the name of the field where the change occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Operation", "definition": "Displays the type of operation that was performed, for example, New Record, or Modify.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Old Value", "definition": "Displays the value in the field before the database change occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "New Value", "definition": "Displays the value in the field after the database change occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Record ID", "definition": "Displays the unique identifier of the record that was changed.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Base Table", "definition": "Displays the name of the primary database table where the database change occurred. 161", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Column", "definition": "Displays the name of the column in which the change occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Group ID", "definition": "Displays the unique identifier of the group to which the user who changed the record belongs.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Node", "definition": "Displays the name of the database table node where the change occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Table", "definition": "Displays the name of table to which the selected field belongs in the Siebel database.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Row ID", "definition": "Displays the unique identifier of the row in which the change occurred. Generating Oracle BI Publisher Reports for Site Visits You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. For more information about using Siebel Reports and integrating with Oracle BI Publisher, see Siebel Reports Guide . The following preconfigured reports apply to site visits: \u2022 Clinical Trip Report With CRF \u2022 Clinical Trip Report Without CRF To generate an Oracle BI Publisher report for a site visit 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to generate an Oracle BI Publisher report. 3. On the application toolbar, click Reports. 4. In the Run Report pane, complete the necessary fields as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Employee ID", "definition": "Displays the unique identifier of the user who changed the record. Generating Oracle BI Publisher Reports for Site", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Enrollment Status", "definition": "You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. The preconfigured Site Enrollment Status report applies clinical trials. For more information about using Siebel Reports, and integrating with Oracle BI Publisher, see Siebel Reports Guide . To generate an Oracle BI Publisher report for the site enrollment status 1. Navigate to the Protocols screen, then the Protocol List view. 2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate an Oracle BI Publisher report. 3. Navigate to the Sites view. 4. On the application toolbar, click Reports. 5. In the Run Report pane, complete the appropriate fields as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Report Name", "definition": "Select the Clinical Trip Report With CRF report or the Clinical Trip Report Without CRF report.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Output Type", "definition": "Select the output type for the report. 5. Click Submit. The report runs. 162", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Managing Sites and Contacts for Clinical Trials", "definition": "To generate a report for planned and actual dates of subject visits 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to generate an Oracle BI Publisher report. 3. On the application toolbar, click Reports. 4. In the Run Report pane, complete the appropriate fields as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Adding Notes to Sites", "definition": "When you work with site records, you often find that you want to make notes. In the Notes view, you can enter public notes or private notes. Use the link bar in the Notes view to switch between public and private notes. Anyone who can access the record can see a public note. Only the person who creates the note can see a private note. This task is a step in Process of Managing Sites and Contacts for Clinical Trials. 109", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Payee Last Name", "definition": "Select the payee last name from the list. The list displays all primary accounts for the selected contract.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit Name", "definition": "The name of the site visit.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit Start", "definition": "Starting date of the site visit.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit Status", "definition": "Select the status of the site visit, for example, Planned or Completed.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trip Report Completed", "definition": "Select the date that the trip report is complete and ready for submission. This field is populated with the system date when you update the Visit Status field of the trip report to Completed. 146", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trip Report Status", "definition": "To use audit trail for changes to a clinical trip report 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report. The Trip Report form for the selected site visit appears. 3. Navigate to the Audit Trail view. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rejected", "definition": "The reviewer or approver rejected the trip report.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "To group site visits", "definition": "1. Navigate to the Site Visits screen. The existing Clinical Site Visits are listed, if any. 2. Do one of the following as required: \u25e6 Click All Visits to see a complete list of all visits, irrespective of the Visit or Trip Report status. \u25e6 Click Pending Visits to see a list of all visits in Pending Visit status. \u25e6 Click Pending Approval to see a list of all visits in Pending Approval status. \u25e6 Click Closed Visits to see a list of all visits in Closed Visit status. The following table shows the default Visit and Trip Report status combinations for Site Visits that are defined in Siebel Tools.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Closed Visits", "definition": "Reviewed with Comments Submitted with Approval", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Revised", "definition": "The end user modified the rejected trip report, and it is not yet resubmitted for review.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Last Name", "definition": "The first name of the contact.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Address Type", "definition": "Select an address type from the list of values to associate with the site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Address Line 1", "definition": "Select the appropriate site location from the MVG (multi value group). Assigning Employees to Site Teams CRAs (clinical research associates) assign employees to the site team. You can roll up the team members and make them visible at the region and protocol levels. Note: If the CRA is working from a mobile Web client, then the administrator must set up position rollup on the Web client. For more information, see Setting Up Mobile Web Clients for Position Rollup. Before you can add an employee to the site team, an administrator must set up the employee record. For more information, see Siebel Security Guide . You can also automatically assign an employee to the site team using the Position Rollup button or Position Rolldown button. For more information, see Automatically Assigning Team Members Using the Position Rollup and Rolldown Buttons. For more information about removing employees from the site team, see About Removing Team Members From the Team of a Site. This task is a step in Process of Managing Sites and Contacts for Clinical Trials. To assign employees to the site team 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, select the site to which you want to add employees. 3. Edit the Team field of the site record. The employees are added to the site team. You also roll up the employees to the region and protocol levels. Creating Activity Plans for Sites An activity plan for a site is a list of activities and documents associated with the site. Although you can create activities without a template, using a clinical protocol site template as described in this topic makes creating activities for sites more efficient. For more information, see Creating Clinical Protocol Site Templates. 100", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Planned Start", "definition": "Select the date and time to start the activity plan.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Template", "definition": "Select the template for the activity plan. Only templates with a type of Clinical Protocol Site and with a protocol that matches the protocol at the site are available for selection. Only activities with type of Document or Site-Initiation appear in the document tracking views.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Expected Date", "definition": "Select the date that the site is expected to return the signed document.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sent Date", "definition": "Select the date that you send the document to the site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Received Date", "definition": "Select the date that the site returns the signed document.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Expiration Date", "definition": "Select the date that the document expires. 103", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Suppress Calendar", "definition": "Select this field to indicate that the activity does not appear on the user\u2019s calendar. Applying Activity Templates to Sites You can simultaneously apply one or multiple activity templates to one or multiple sites for a study. Activity records with a type of Document and Site-Initiation appear in the Document Tracking view of the Site Management screen. Activity records with a type of Correspondence appear in the Activities view of the Site Management screen. The applied templates also appear in the Activity Plans view of the Site Management screen for each of the selected sites. This task is a step in Process of Managing Sites and Contacts for Clinical Trials. Applying Activity Templates to Sites in a Region Complete the procedure in this topic to simultaneously apply one or multiple activity templates to multiple sites in a region. To simultaneously apply one or multiple activity templates to multiple sites in a", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Protocol", "definition": "The protocol or study ID.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Activity", "definition": "Select the type of trip report activity. The following values are available: 144", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Activity Type", "definition": "Select an activity type. The following values are available: \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Retrieved", "definition": "Select this field when you retrieve the CRFs from the site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Retrieved Date", "definition": "Select the date and time that the CRF is retrieved.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Received in House", "definition": "Select the date and time that the CRA (clinical research associate) receives the CRF in house. Received by Data Management Select the date and time that a data management process receives the CRF.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Source Verified", "definition": "Select this field when you verify the CRF against the source document.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Source Verified Date", "definition": "Select the date and time that the CRF is source verified. 107", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Note Type", "definition": "Select the type of note. Examples include Exclusion, Pre-existing Condition, Permanent, System, Temporary, Business Description, Regional Plans, and Contracts Process.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Note", "definition": "Type the note text. 5. Click Check Spelling to make sure your note has no spelling errors. Viewing the Status History for Sites For each site, you can view information about how the Status field changed in the past. To view the status history for a site 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to view the status history. 3. Navigate to the Status History view. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Old Status", "definition": "Displays the value in the Trip Report Status field before the change occurred.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "New Status", "definition": "Displays the new value in the Status field for the site record.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Tracking", "definition": "You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) for generating reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. For more information about using Siebel Reports and integrating with Oracle BI Publisher, see Siebel Reports Guide . 111", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subject Visits", "definition": "This topic describes how to generate the preconfigured Planned vs Actual Patient Dates report for Oracle BI Publisher. This report lists the planned and completed subject visit dates for a site. This task is a step in Process of Managing Sites and Contacts for Clinical Trials. 115", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Managing Partial Source Data Verification", "definition": "To recalculate the subjects requiring source data verification 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of a site record. 3. Navigate to the More Info view. 4. Click Reapply Auto-Select Rate. If the value in the Number of Initial Subjects field or the Subject Auto-Select Rate field changed, then the value in the Total Subjects Requiring SDV field is recalculated, and this recalculation considers the subjects in the site pool. About Partial Source Data Verification for Protocol", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit Templates", "definition": "This topic describes how to set up PSDV (partial source data verification) for subject visit templates. You set up this verification by entering PSDV values in some fields when you create a record for a subject visit template. These values are automatically populated in the same fields for all of the CRF (case report form) tracking records that are associated with the subject visit template. 119", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SDV Required", "definition": "Displays an indication of whether SDV (source data verification) is necessary for the site visit. This field is read-only, and automatically populated from the value of the same field in the subject visit template that is associated with this CRF tracking record. Page Numbers to Verify Displays the page numbers of the CRF that are included in PSDV. This field is read-only, and automatically populated from the value of the same field in the subject visit template that is associated with this CRF tracking record. Tracking Case Report Forms for Partial Source Data Verification During Site Visits This topic describes how to track the CRFs (case report forms) for PSDV (partial source data verification) during a site visit. During a site visit, CRAs (clinical research associates) do not review all CRFs and all pages on those CRFs. The field values for PSDV in the subject visit template that is associated with the site visit determine the information that appears in the PSDV fields of CRFs. The CRA restricts the review to the information in these PSDV fields. To track the case report forms for partial source data verification during a", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SDV Policy", "definition": "Select the Source Data Verification Policy.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Verification", "definition": "If you change the value in the Number of Initial Subjects field or the Subject Auto-Select Rate field of a site record, then you must recalculate the value in the Total Subjects Requiring SDV field of that site record. If you change the number of subjects in the site pool by changing the value in the SDV Required field of the site\u2019s subject records, then you must recalculate the value in the Total Subjects Requiring SDV field of the site record. If you change the number of subjects in other pools, such as the subject pool and the status pool, then you do not have to recalculate the value in Total Subjects Requiring SDV field because these other pools are not included in the calculation of this field. For more information about pools, see Setting Up Partial Source Data Verification for Clinical Subjects. 125", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "site visit", "definition": "1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track case report forms for partial source data verification. 3. Navigate to the Case Report Forms Tracking view. 4. To add case report forms for scheduled subject visits, complete the following steps: 124", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page Numbers Verified", "definition": "Type the CRF page numbers that you verify.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Charts Reviewed Date", "definition": "Select the date and time that you review the clinical charts.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Forms Signed Date", "definition": "Select the date and time that you sign the CRFs. 149", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Amendments", "definition": "When you change a subject visit template, you create a new version of that template. This new version results in a protocol amendment. When you apply the protocol amendment to the subjects, the following processing occurs: 1. The subject visits that are no longer valid are deleted. 2. CRF (case report form) records associated with the subject visits are deleted. 3. New subject visits are created. 4. New CRFs are created with values for PSDV (partial source data verification) fields from the latest version of the subject visit template. For CRFs that already have values for PSDV fields, new CRFs are also created. The values for fields that are not available in the subject visit template are copied from the prior CRFs to the new CRFs, and the values for PSDV fields are copied from latest version of the subject visit template to the new CRFs. 5. Activities are created according to the protocol amendment. 126", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Setting Up and Making Clinical Payments", "definition": "Generating Oracle BI Publisher Reports for Clinical", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subject Activities", "definition": "You set and adjust payments to investigators and sites at the following levels: \u2022 The financial administrator sets standard payment amounts through the subject visit template. \u2022 You set exceptions to standard payment amounts according to agreements that individual sites negotiate. \u2022 You can further adjust payments on a one-time only basis before you generate the payments. Not all subject activities have payment amounts associated with them. For example, obtaining informed consent might be a subject activity for which you do not pay the site, but you pay a site for performing a blood test. Subject activities for which you pay the site are payment subject activities. (In the Siebel Clinical interface, the Payment Flag field indicates these activities.) In addition to subject activities, you can pay sites for other activities that end users create at the site level, such as IRB (institutional review board) fees and equipment costs. End user can designate those activities as payable to the site with the Payment Flag field. For information about managing budgets at the protocol level, see Managing Clinical Projects. 127", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Templates", "definition": "Select the template for the activity plan.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contract", "definition": "Select the payee contract from the list of contracts.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Payee First Name", "definition": "Displays the payee first name. Generating Payment Records for Sites This topic describes how to generate payment records from payment activities. Payments are generated for each unique contract, account and payee combination for complete payment activities. To generate a payment record for a site 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to generate a payment. 3. Navigate to the Payment Activities view. 4. In the Payment Activities list, select the Completed field for each payment activity to use for generating the payment record. 5. Click Generate Payment. The complete payments are removed from the Payment Activities list. Payment records for each unique contract, account and payee combination are generated in the Payments list. Generating Payment Records for Sites Associated with Clinical Protocols and Regions You can generate payment records for the sites that are associated with a clinical protocol and with a clinical region. After you complete the payment generation task, the payment records can appear in the Payments view in the Protocol List view of the Protocols screen and in the Payments view in the Region List view of the Regions screen. Also, the payment records appear in the Payments view in the Protocol Site List view of the Site Management screen. Payment 133", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Split Percentage", "definition": "Type the split percentage for each payment split. The total split percentage for all of the payment splits must be one hundred percent. The split percentage is automatically calculated if you manually enter the amount in the Split Amount field. 130", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Split Amount", "definition": "Displays the split amount by using the split percentage of the total payment amount. You can also manually enter the amount. 7. After you create all payment splits, verify that the Split Status (icon) in the Payment Exceptions view is activated (or green in color), which indicates that the total splits for the payment amount to one hundred percent. Copying Details for Payment Splits You can copy the details of a split payment activity to multiple payment activities. You copy payment activity splits at the payment exceptions level. To copy details for a payment split 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to copy split payment details. 3. Navigate to the Payment Exceptions view. 4. In the Payment Exceptions list, select the record that you want to copy. 5. Click Apply Split to Other. The Payment Activities Select Applet appears. 6. Select the payment activities to which you want to apply the split details, and click OK. The split details are created in the Split Details applet for all of the selected payment activities. 7. Navigate to the Split Details applet, and make any required amendments. Reversing Splits for Payment Activities This topic describes how to reverse a payment activity split. The split details for each payment are deleted from the Split Details applet. To reverse a split for a payment activity 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to reverse payment activity splits. 3. Navigate to the Payment Exceptions view. 4. In the Payment Exceptions list, select the records that you want to reverse. 5. Click Unsplit. 6. Click OK to delete the split details for the selected payment activities. The split details for each selected payment activity are deleted from the Split Details applet. 131", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Payment", "definition": "Select this field to define the activity as a payment activity.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Standard Amount", "definition": "Type the payment amount prior to any adjustment. The actual amount is calculated as follows: Standard Amount plus Deviation Amount equals Actual Amount 5. Click Generate Payment. The complete payments are removed from the Payment Activities list, and the payment record is created in the Payments list. 6. To complete the payment, follow Step 6 to Step 8 in Adjusting Payment Amounts and Generating Payment Records for Sites. Adjusting Payment Amounts and Generating Payment", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Deviation Amount", "definition": "Type a value in this field to adjust the value in the Actual Amount field. 132", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Actual Amount", "definition": "Displays the actual amount to pay to the site. The actual amount is calculated as follows: Standard Amount plus Deviation Amount equals Actual Amount", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Activities", "definition": "Follow the steps to assign CPT Codes and Billing Designation to Visit Template activities: Note: A new mandatory field of \u2018Branch\u2019 has been added to Visits in SVTs. 1. In Activities, go to the CPT Code field. 2. Select Charge Sheet item from the associated Charge Sheet version from a pick list. The CPT Code, CPT Description, and Payment Amount is populated after the selection. 3. Select a value for Billing Designation from the following default values: \u25e6 Standard of Care (SOC) \u25e6 Research Related (RR) \u25e6 Non Billable (NB) 306", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Records for Sites", "definition": "Although payments are generally set for each site, occasionally the financial administrator might want to make additional adjustments to the paid amount for a given payment activity. For more information, see Setting Payment Exceptions for Sites. When the financial administrator finalizes the amounts, payments are generated for all complete payment subject activities in the currency for the site. Each payment record is given a unique identity number. You can later enter other information, such as check number, check date, and check amount, either manually or by importing the data from a back-office finance application. Note: This task requires administrator privileges. To adjust the payment amounts and generate payment records for a site 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to generate payments. 3. Navigate to the Payment Activities view. This view lists all scheduled payment subject activities for subjects associated with the site. 4. (Optional) Adjust the Actual Amount to pay to the site by entering a value in the Deviation Amount field. Standard Amount plus Deviation Amount equals Actual Amount 136", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Earned Amount", "definition": "Type the sum of the actual payment amounts for the complete payment activities. The sum of all values in the Earned Amount column equals the Earned to Date value of the site.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Requested Amount", "definition": "Displays the requested amount of payment for the complete payment activities at this site. This field is calculated as follows: Requested Amount equals Earned Amount times [(100 less Withholding Percentage divided by 100) less Withholding Amount]", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Check Amount", "definition": "Type the amount of money for the check. This field is usually, but does not have to be, the same as the earned amount.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Check Date", "definition": "Select the issue date for the check.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Check Number", "definition": "Type the number of the check.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "VAT Amount", "definition": "Type the value added tax for the site payment. The total VAT amount for all payments is rolled up to the region, protocol, and program levels, and appears in the VAT to Date field. 138", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "To Be Processed", "definition": "The Revert button is disabled for other statuses, and if you select multiple records. Your system administrator can modify the payment status values for which the Revert button is enabled by configuring the LS Clinical Enable Revert On Status user property in Siebel Tools. For more information about this user property, see User Properties for Business Components in Siebel Clinical. A reverted payment activity record is removed from the Payments view and returned to the Payment Activities view. To revert a payment record 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to revert a payment. 3. Navigate to the Payments view. 4. Select the payment to revert. 5. Click Revert. The payment records and split payment activities are updated as follows: \u25e6 The reverted payment activity record is removed from the Payments view and returned to the Payment Activities view for further processing. \u25e6 If the payment record consists of multiple payment activities, and if you revert only some of the payment activities, then the Earned Amount and Requested Amount fields are recalculated for the Payment record. 139", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Payments", "definition": "You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. The preconfigured Protocol Payments report applies to clinical payments. For more information about using Siebel Reports and integrating with Oracle BI Publisher, see Siebel Reports Guide . To generate an Oracle BI Publisher report for Siebel clinical payments 1. Navigate to the Protocols screen, then the Protocol List view. 2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate an Oracle BI Publisher report. 3. Navigate to the Payments view. 4. On the application toolbar, click Reports. 5. In the Run Report pane, complete the appropriate fields as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Administering and Using Clinical Trip Reports", "definition": "6. Click My Reports to navigate to the Reports view of the BI Publisher Reports screen. A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide . 163", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Reports", "definition": "A third-party application records dates, times, and geographical location details for sites in the trip report for each site monitor visit to each clinical site. Multiple site monitors can create multiple site visit records in the trip report for the same site visit. Each site monitor can create multiple site visit records in the trip report for different times on the same site visit. To view geographical location details for a clinical trip report 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to view geographical location details. The Trip Report form for the selected site visit appears. 3. Navigate to the Geo Location Details view. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Site close-out", "definition": "Preparing Trip Reports The CRA (clinical research associate) is the end user of the Siebel Clinical product. Before visiting a site, the CRA uses the trip report to prepare for the visit. The follow-up items list reminds the CRA of the open activities from previous visits that the CRA can close. After preparing a draft trip report, the CRA makes a hard copy of the report and takes this copy on the site visit. He can use the report as a reference to help keep track of the activities he completes while at the site. After returning from a site visit, the CRA completes the trip report and generates a final report. He then submits this report to the study manager for approval. The manager reviews the report and approves it if it is satisfactory. If the manager approves the trip report, then it is then locked to prevent the CRA from making any further changes. If the trip report is not satisfactory, then the manager can reject the report and return it to the CRA for further attention. 142", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SmartScript", "definition": "Select a SmartScript questionnaire for the trip report template. The questionnaire is copied to the Questions view of the trip report when you apply the trip report template to the trip report. The questionnaire uses branching logic to dynamically determine the flow of questions by using answers to prior questions. The Siebel Clinical Trial Management System administrator determines the question hierarchy by using Siebel SmartScript. For more information about Siebel SmartScript, see Siebel SmartScript Administration Guide . 3. Drill down on the Name field of the trip report template to display the Trip Report Template Details view. 4. Create new records to define each trip report activity.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Question Setting", "definition": "Questionnaire Exception for Clinical Trip Reports", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Answer Type", "definition": "The Currency data type is not supported.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Auto Sub Parm", "definition": "This setting is not applicable.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Search Spec", "definition": "This setting is not applicable.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Save Business Object", "definition": "This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Save Bus Comp", "definition": "This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Save Field", "definition": "This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Save Currency Field", "definition": "This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Pick Applet", "definition": "This setting is not supported.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Mvg Applet", "definition": "This setting is not supported.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Detail Applet", "definition": "This setting is not supported.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Save Answer Table", "definition": "This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports. 143", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Currency", "definition": "This setting is not applicable. You can assign a SmartScript questionnaire to a clinical trip report template after it is released using Siebel SmartScript. For information about how to release a script using Siebel SmartScript, see Siebel SmartScript Administration Guide . Creating Clinical Trip Report Templates Typically, the clinical administrator prepares a number of generic trip report templates, perhaps one designed for each of the different stages in the study. This topic describes how to create a clinical trip report. You can define additional activities, such as follow-up tasks to complete after the visit to the clinical site, in the Trip Report Template Details view. To create a clinical trip report template 1. Navigate to the Administration - Clinical screen, then the Trip Report Templates view. 2. Create a new record and complete the necessary fields as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Priority", "definition": "Select the priority of the trip report activity. Applying Clinical Trip Report Templates The Template field of the Site Visits view displays all of the trip report templates that are applicable to protocol, region, and visit type details for that site visit. When you apply a trip report template to a trip report, all of the details in the template are copied to the trip report. Checklist and follow-up activities in the Trip Report Template Details view of the trip report template are copied to the trip report, and overwrite any existing checklist and follow-up activities in the trip report. SmartScript questionnaires in the SmartScript field of the trip report template are applied to the trip report, and appear in the Questions view. For performance reasons, the SmartScript questionnaire does not appear in the Questions view until after the user launches the SmartScript questionnaire. For more information about SmartScript questionnaires, see Completing Questionnaires for Clinical Trip Reports. To apply a clinical trip report template 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit to which you want to apply a trip report template. The Trip Report form for the selected site visit appears. 3. Click the select button in the Template field. A list of templates that correspond to the protocol, region, and visit type details for the site appears. 4. Select the name of the trip report template that you want to apply, and click OK. When you save the Template field, the activities in the template appear in the Checklist Activities list and Follow-Up Items list. Completing Clinical Trip Reports After the site visit, you record the trip report details, such as: \u2022 The planned activities that you complete \u2022 Additional activities that you complete 145", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Reviewer Comments", "definition": "Type reviewer comments about the trip report. Only the assigned reviewer can modify this field.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Approver Comments", "definition": "Configure the value as follows: \u2022 To enable this property, set the value as follows: \"Rejected\", \"Y\" \u2022 To disable this property, set the value as follows: \"Rejected\", \"N\" This property is enabled by default.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Attendees", "definition": "Select the contacts (site personnel) that you meet during the visit.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Reviewer", "definition": "Select the user who reviews the trip report. An automated email notification is sent to the reviewer when you update the status of the trip report to Submitted.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Approver", "definition": "Select the user who approves the trip report. An automated email notification is sent to the approver when the reviewer updates the status of the trip report to Submitted for Approval.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Trip Reports", "definition": "The Inbox provides a centralized list of items requiring your attention, such as clinical trip reports requiring review, revision, and approval. The following procedure shows you how to access and view Universal Inbox notifications for action items of clinical trip reports. Alternatively, you can click Notification on the application banner to access and view all notification messages, including those for clinical trip reports. Note: The Notifications feature is enabled by default for all Siebel Business Applications so all notification messages for clinical trip reports are sent directly to the screens of users. Messages appear in notification panes that users access by clicking Notification on the application banner. For more information about using, administering and reviewing notifications, see Siebel Fundamentals Guide . 154", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "report", "definition": "1. From the application-level menu, choose Navigate, then Site Map. 2. Click Inbox. The views available for the inbox appear. 3. Click Inbox Items List. The list of notifications for your trip reports appears. The action required for each trip report appears in the Name field. 4. Drill down on the Name field to view each trip report requiring action. Enabling a Trip Report Completed Alert The following procedure shows how to enable an alert pop-up message to automatically appear when you try to complete a trip report (that is, set the Status of the trip report to Completed) without updating at least one of the Open Follow-Up items for the report. Once enabled, the following alert pop-up message appears when you try to complete a trip report without updating the Follow-Up items for the report: Follow-Up items have not been updated for this Trip Report. Are you sure you want to proceed? Click OK to close the alert message and proceed with trip report completion. To enable a trip report completed alert 1. Log in to Siebel Tools. 2. Set the Follow-Up Update Alert user property for the Clinical Trip Report business component to Y (N or Null is the default value) to enable the trip report completed alert. The trip report status that triggers the Follow-Up Update Alert is Completed by default. Follow-Up Update Alert = N Follow-Up Update Alert Status = Completed 3. (Optional) To change the trip report status that triggers the Follow-Up Update Alert, set the Follow-Up Update Alert Status user property for the Clinical Trip Report business component to a different trip report status. For example: Follow-Up Update Alert Status = Revised Reviewing Clinical Trip Reports The user designated in the Reviewer field of the Trip Report form can review trip reports with a status of Submitted. An automated notification email is sent to the reviewer when an end user updates the trip report status to Submitted. Access control applies to the Reviewer Comments field. Only the user designated in the Reviewer field of the Trip Report form can edit the Reviewer Comments field. 155", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Questions Answered", "definition": "Displays the number of answered questions, the total number of SmartScript questions for the trip report, and the SmartScript questionnaire status. The value ranges are as follows: \u25e6 0 of 0, Not Assigned. The user has not assigned a SmartScript questionnaire to the trip report. \u25e6 [Total Answered] of [Total Questions], In Progress. The user launched the SmartScript questionnaire, and it is in progress. \u25e6 [Total Answered] of [Total Questions], Finished. The user completed answering all of the questions. The drill-down navigates to the Questions view. Current Follow-Ups Completed Displays the number of completed follow-up activities and the total number of follow-up activities for the current trip report. The drill-down navigates to the Current Trip Follow- Up Items view. All follow-ups in the Current Trip Follow-Up Items view with a value in the Completed Date field are listed as completed in the Summary view. 150", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Total Attendees", "definition": "Displays the total number of attendees assigned to the trip report. Tracking Status Accruals for Clinical Subjects of Sites This task describes how to track the progress of subject status accruals for a clinical site by creating a real-time snapshot of the current subject status accruals for the site. The CRA (clinical research associate) can use the snapshot to verify the subject status data that an end user manually records during a site visit. To track status accruals for clinical subjects of a site 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track the status accruals for subjects. The Trip Report form for the selected site visit appears. 3. Navigate to the Summary view. 4. Click Capture in the Subject Status Snapshot applet to generate a real-time snapshot of the status accruals for clinical subjects. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Checklists Completed", "definition": "Displays the number of completed checklists and the total number of checklists. The drill-down navigates to the Checklist Activities view. All checklists in the Checklist Activities view that have a Status of Done or Completed are listed as completed in the Summary view.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subject Status", "definition": "Displays the subject status. The following subject visit statuses are preconfigured: 151", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Total Actual Number", "definition": "Type the number of current and past subject status accruals that you manually recorded during the site visit. Current Accrual Number Displays the number of current subject status accruals that are automatically created for the site visit.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Current Actual Number", "definition": "Type the number of current subject status accruals the you manually recorded during the site visit.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Time Stamp", "definition": "Displays the date and time that the snapshot is generated. Automated Validation and Notification Messages for", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Not Started", "definition": "The end user created the trip report, but processing is not yet started. This status is the initial default value for all trip reports.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "In Progress", "definition": "The end user started to work on the trip report, and it is not yet complete. System, if the trip report is created using a template. User, if the trip report is not created using a template. N/A N/A", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "the Completed Date is", "definition": "populated. The Completed Date is a prerequisite for selecting Completed. If enabled, an alert pop- up message will appear if you try to complete a trip report without updating the Follow-Up items for the report. For more information, see Enabling a Trip Report Completed Alert.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Submitted", "definition": "The end user submitted the trip report to the reviewer for review.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "The trip report is", "definition": "validated to ensure that an approver is assigned. The following automated", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "email is sent to the", "definition": "approver: Approve Trip Report [Trip Report Name].", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "If you change the", "definition": "reviewer when the Trip Report Status field is Submitted, then this notification email is sent to the new reviewer.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "added review comments", "definition": "requiring a modification to the trip report.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "User", "definition": "Not applicable. N/A Submitted for Approval The reviewer submitted the trip report for formal review, without comments or with comments that do not require a change to the trip report.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "one of the following", "definition": "fields is completed: The following automated message is sent to the trip report owner: Rectify Trip Report [Trip Report Name]. 153", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "If the you change the", "definition": "approver when the Trip Report Status field is Submitted for Approval, then this notification email is sent to the new approver.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Approved", "definition": "The approver approved the trip report, and it is now read- only. When the approver clicks the Approved button, the Trip Report Status field is updated to Approved.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "User Id", "definition": "Displays the user ID of the site monitor who logs the geographical location details in the third- party clinical application.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Latitude", "definition": "Displays the latitude coordinate of the site. Latitude coordinates are represented in decimal degree format. The range of acceptable values is 0 to plus or minus 90. Northern hemisphere latitudes are represented by a positive number. The number is preceded by a minus sign to represent southern hemisphere latitudes. 159", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Longitude", "definition": "Displays the longitude coordinate of the site. Longitude coordinates are represented in decimal degree format. The range of acceptable values is 0 to plus or minus 180. Eastern hemisphere latitudes are represented by a positive number. The number is preceded by a minus sign to represent western hemisphere longitudes.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Login", "definition": "Displays the login credentials of the user who modified the field.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Managing Clinical Projects", "definition": "2. In the Project list, drill down on the Name field of the project. 3. Navigate to the Costs view. 4. Click a hyperlink in the Clinical Payments or Project Tasks list to see the activities associated with a cost item. Managing Risk for Clinical Projects An important aspect of project management is risk management. The features of the Risks view allow you to enter information about project risks and create and assign resolution activities to address the risks. For more information about assessing risks for project management, see Siebel Project and Resource Management Administration Guide . This task is a step in Process of Managing Clinical Projects. To manage risk for clinical projects 1. Navigate to the Projects screen, then the List view. 2. In the Project list, drill down on the Name field of the project. 3. Navigate to the Risks view. 4. In the Risks list, create a new record and complete the necessary fields. 5. In the Risks list, drill down on the Name field. 6. In the Resolution Activities list, create a new record and complete the necessary fields. About Views in the Projects Screen Many views are available in the Projects screen of the Siebel Clinical. You can choose to use only some of these views. The following table describes the views that are available in the Projects screen.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Administrator Tasks", "definition": "The tasks that an administrator must complete to support projects depends on the project features that the organization uses. You might not have to perform all the tasks listed in this topic. These tasks must occur before the project manager creates the project. The following list shows the tasks administrators typically perform to manage clinical projects: \u2022 Creating Activity Templates for Clinical Projects. Many project managers use these templates to carry out similar clinical trials. \u2022 Setting Up Employee Profiles for Clinical Projects. Maintain the employee profiles of skills and competencies that Siebel Assignment Manager uses. 166", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Project Resource", "definition": "Select this field to indicate that the product is a project resource.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Creating Rate Lists", "definition": "Complete the procedure in this topic to create a rate list.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "To create a rate list", "definition": "1. Navigate to the Administration - Pricing screen, then the Rate List view. 2. In the Rate Lists list, create a new record and complete the necessary fields. 3. In the Rate Lists list, drill down on the Rate List field. 4. In the Rate List Line Items list, create a new record. 5. In the Add Position Types dialog box, select the Position Type and click OK. This list of resources is created as a product. 6. In the Rate List Line Items list, complete the remaining fields. Creating Clinical Projects You can create a project record and associate a protocol with the project. 168", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Project ID", "definition": "Type a unique identification number for the project.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Start", "definition": "Select the start date and time for the project.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "End", "definition": "Select the end date and time for the project. Protocol # Select the protocol for the project. All available protocols are available for selection from the Pick Protocol dialog box. The project creator does not have to be a member of the protocol team.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Actual Cost", "definition": "Displays the actual cost of the project. This field is calculated by summing the actual costs of all the tasks, activities, and site payments associated with the project.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Revenue", "definition": "Type the total revenue for the project. Click the currency calculator button for this field to enter the amount of revenue, the currency, and the exchange date for the currency.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Budgeted Cost", "definition": "Displays the budgeted cost of the project. This field is calculated by summing the budgeted costs of all the tasks, activities, and site payments associated with the project. 169", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rate List", "definition": "Select the rate list for the project if a rate list is set up for the project team members. Click the show more button if this field is not visible. For more information, see Setting Up Position Types and Rate Lists for Billing.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Access", "definition": "Use this view to provide project access. Add the names of the project team members and also managers or executives who want access to monitor the progress of the project. The Access view has a similar function to the Team field in other screens.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Activity Plans", "definition": "Select Yes if you want to create activity plans for this site, otherwise select No.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Attachments", "definition": "Use this view to attach project documents. For general information about attachments, see Siebel Fundamentals .", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Calendar", "definition": "Use this view to manage a monthly calendar of the activities associated with the project. Activities belonging to tasks and standalone activities appear in this view. For general information about the calendar views, see Siebel Fundamentals . 173", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Financial Profile", "definition": "Use this view to gain an overall perspective of a project\u2019s financial information, status, and progress. You can change the Delivery status for the project. For more information, see Siebel Project and Resource Management Administration Guide .", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Invoices", "definition": "Use this view to create invoices for time and expenses that apply to a project. For more information, see Siebel Project and Resource Management Administration Guide .", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Notes", "definition": "Use this view to keep private and public notes about the project. For general information, see Siebel Fundamentals .", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Orders", "definition": "Use this view to create a product or material order and associate it with the project. For more information, see Siebel Project and Resource Management Administration Guide . Organizational Analysis Use this view to see an organizational chart of contacts that shows the relationships between them.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Partners", "definition": "Use this view to maintain a list of partner accounts associated with the project. You can keep a list of accounts associated with the project, such as vendors who handle printing of the clinical trial materials or shipping of sample drugs. Because the views for Partners, Subcontractors, and Clinical Contacts contain account information, you can use one or more of these views to keep track of accounts associated with a project.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Risks", "definition": "Use this view to maintain a list of the risks associated with the project and resolution activities required to address those risks.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Status Report", "definition": "Use this view to create a status report summarizing the project\u2019s progress, forecast, and issues. For more information, see Siebel Project and Resource Management Administration Guide .", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subcontractors", "definition": "Use this view to keep a list of subcontractors associated with the project. For more information, see the description of the Partners field.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Tasks", "definition": "Use this view to create and modify tasks for the project.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Team Workbook", "definition": "Use this view to assign team members to roles in the project. You can manually assign team members, or Siebel Assignment Manager can automatically assign them. Team members must be listed in the workbook before you can assign them to activities. Time & Expense Use this view to adjust and summarize time sheets and expense reports associated with the project. For more information about time sheets and expense reporting, see Siebel Project and Resource Management Administration Guide . 174", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Managing Clinical Training", "definition": "To view the training information for a clinical region 1. Navigate to the Regions screen, then the Region List view. 2. In the Region list, drill down on the Region field of the region for which you want to view training information. 3. Navigate to the Training view. 4. Click Refresh to update the view with the latest information about completed training. 5. Review the training information in the training overview applet. Some fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Mandatory", "definition": "Select this field to indicate that completing the training topic is mandatory.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Duration Unit", "definition": "Select the units of time that apply to the numeric value that you enter in the Duration field.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Created Date", "definition": "Displays the date and time that you create the version of the training plan. 180", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Obsolete Date", "definition": "Select the date and time that the training plan is inactive. After you populate this field and then save the plan record, you cannot change the field values for the training plan, the criteria for the training plan, or the versions for the training plan. You cannot delete training plans. If you want to indicate that the training plan is again active, then clear this field. After the training plan is again active, you can change it. Sites Processed/ Total Sites Displays the number of sites that the publishing process associated with the training plan (sites processed) compared to the number of sites that apply to the training plan (total sites). This field is automatically populated when you publish the training plan. If you successfully publish the training plan, then the number of processed sites equals the number of total sites. If you fail to successfully publish the training plan, then the number of processed sites is not equal to the number of total sites. If you create a new approved version of the training plan, then this field value is cleared. % Completed Displays the fraction in the Sites Processed/Total Sites field as a percentage. This field is automatically populated when you publish the training plan. If you successfully publish the training plan, then this field value is 100%. If you fail to successfully publish the training plan, then this field value is less than 100%. If you create a new approved version of the training plan, then this field value is cleared.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Version Number", "definition": "Displays an automatically generated version number. The first version record that you create is automatically populated with a version number of 1, the second version record that you create is automatically populated with a version number of 2, and so on.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Process Status", "definition": "Displays the status of the publishing process for the training plan as follows: \u25e6 When you create a new record for a training plan, this field value defaults to Not Started. \u25e6 When you click the Publish button to publish the training plan, this field value changes from Not Started to Publishing. \u25e6 After publishing is complete, and publishing is unsuccessful, this field value changes from Publishing to Failed. \u25e6 After publishing is complete, and publishing is successful, this field value changes from Publishing to Published. \u25e6 When you select a value of Approved in the Status field for a new version (but not the first version) of the training plan, and then save the version record, this field value changes from Published to Not Started.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Publish Result", "definition": "Displays the final result of the process to publish the training plan. If you create a new approved version of the training plan, then this field value is cleared. 178", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Scope", "definition": "Select the scope of the training plan as follows: \u25e6 If you select a value of All, then the training plan applies to all sites in Siebel Clinical, and you cannot enter values in the other fields of the Training Plan Criteria list. You cannot create more criteria records for the training plan. \u25e6 If you select a value of Specific, then the training plan applies to specific sites in Siebel Clinical, and you designate these sites in the other fields of the Training Plan Criteria list. You can create more criteria records for the training plan.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Indication", "definition": "Select the clinical indication that applies to the training plan.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trial Phase", "definition": "Select the trial phase that applies to the training plan.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Site Status", "definition": "Select the site status that applies to the training plan. Protocol # Select the protocol number that applies to the training plan. The values that you select for the indication and trial phase determine the values that are available to you for selection in this field. If you select a protocol number and subsequently select a value for an indication or a trial phase that is not associated with that protocol number, then the criteria record that you create has no effect because no protocols meet the criteria.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Published Date", "definition": "Displays the date and time that you publish the version of the training plan.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Total Trainings", "definition": "Displays the total number of training topics for the region. Each of these topics appears in the training details applet.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trainings Completed", "definition": "Displays the number of training topics that all associated contacts completed for all the sites in the region.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sites Completed", "definition": "Displays the number of sites in the region for which all associated contacts completed the training topic.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Topic Name", "definition": "Displays the training topic name for the region. If a topic associated with a site record for the region does not apply to any contacts for the region, then that topic does not appear in the training details applet.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Sites Not Completed", "definition": "Displays the number of sites in the region for which all associated contacts have not completed the training topic. 187", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Siebel Clinical Task-Based UI", "definition": "b. Click Transfer. c. In the Transfer To dialog that appears, select the user to whom you want to transfer the task. d. Enter a comment in the Comments box to notify the user and then click OK. 5. To delete a task: a. Select a task in the Inbox Items List. b. Click Delete Task. 201", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Creating Protocols", "definition": "The following procedure shows how to create a protocol using Siebel Clinical task-based UI.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Creating Sites", "definition": "The following procedure shows how to create a site using Siebel Clinical task-based UI.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Tasks", "definition": "By default, Siebel Clinical administrators can access all the predefined task-based UI clinical tasks. To assign another responsibility to one or all of the predefined clinical tasks, then complete the steps in the following procedure. 190", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "To create a protocol", "definition": "1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical. 2. Click Create Protocol in the Task Pane applet. 3. Enter protocol data on the page that appears - the fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Central Lap", "definition": "Select the Account name to assign the associated central lab.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "To create a site", "definition": "1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical. 2. Click Create Site in the Task Pane applet. 3. Enter site data on the page that appears - the fields are described in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Site Contacts", "definition": "Select Yes if you want to create contacts for this site, otherwise select No.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "RACT Assessment", "definition": "Select Yes if you want to create risk assessments for this site, otherwise select No. 4. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 5. If required, click Cancel at any time to cancel the task. 6. Click Submit to do one of the following: a. Submit the task - that is, create the site. 194", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "First Name", "definition": "The last name of the contact.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "City", "definition": "The city where the contact is located. 195", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "State", "definition": "The state where the contact is located.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Postal Code", "definition": "The postal code for the contact's address.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Country", "definition": "The country where the contact is located.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Main Phone", "definition": "The phone number for the contact.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "E-Mail", "definition": "The email address for the contact. 4. If required, click the plus (+) icon to create additional site contacts. 5. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 6. If required, click Cancel at any time to cancel the task. 7. Click the check box next to each contact that you want to associate with the site and then click Submit to submit the task - that is, create the site contact(s). Creating Activity Plans for Sites The following procedure shows how to create activity plans for a site using Siebel Clinical task-based UI. To create an activity plan for a site 1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical. 2. Complete one of the following to create an activity plan for a new or an existing site. a. To create an activity plan for a new site: - Click Create Site in the Task Pane applet. - Enter site data on the page that appears - all fields are described in Creating Sites. - Select Yes for Activity Plans and then click Submit. b. To create an activity plans for an existing site: - Click Other Site Tasks in the Task Pane applet. - Select the record that you want in the Sites list and then click Submit. - Select Yes for Activity Plans and then click Submit. 196", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Supporting Blinded and Unblinded Users for Clinical Trials", "definition": "This topic describes the inheritance hierarchy for blinded and unblinded users. Sites, Regions, and Protocols are never blinded or unblinded in Siebel Clinical. It is the users at the different (site, region, or protocol) levels that are either blinded or unblinded. For example, if a user is blinded at site and protocol level but unblinded at the region level, then that user will automatically have blinded access for all site level work like site visits and activities. However, rolling up or down the configuration will change the type of user access accordingly - see the following tables for more information. Precedence is given to configuration of the Unblinded field for users at site level. If the Unblinded field for a user is updated at site level, then position roll down from protocol and/or region cannot override the Unblinded field definition at site level, since site has more precedence.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Users", "definition": "Access control is the term used to describe the set of Siebel application mechanisms that control user access to data and application functionality. Controlling access to data for blinded and unblinded users involves the following tasks: \u2022 Controlling Access to Blinded Data for Unblinded Users \u2022 Setting Blinded and Unblinded User Access at Protocol Level \u2022 Setting Blinded and Unblinded User Access at Region Level \u2022 Setting Blinded and Unblinded User Access at Site Level \u2022 Setting Access to Unblinded Activities in Core Activities View and Contact Activities View Controlling Access to Blinded Data for Unblinded Users Unblinded users by default see both blinded data and unblinded data, where blinded data is displayed in read-only mode. However, administrators can modify this default behaviour by changing the protocol level setting Hide blinded content for unblinded users. Access to blinded data by unblinded users is controlled by the protocol level setting Hide blinded content for unblinded users. This setting is deselected (set to N) by default in Siebel Clinical, can be changed only by the Siebel Clinical administrator, and is configured at the protocol level. To configure access to blinded data for unblinded users 1. Navigate to the Administration - Clinical screen, then the Protocol List view. 2. In the Protocol list, drill down on a protocol number field. 204", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "unblinded users", "definition": "Y (Selected) Indicates that unblinded users cannot view blinded data, such as Site Visits and Activities. Setting Blinded and Unblinded User Access at Protocol Level The following procedure shows how administrators configure blinded or unblinded user access for protocol team members. To set blinded or unblinded user access at protocol level 1. Navigate to the Administration - Clinical screen, then the Protocol List view. 2. In the Protocol list, drill down on the protocol (number field) for which you want to configure the blinded or unblinded user access. 3. Click the multiple select button in the Team field. A multiple selection dialog box appears showing a list of the available and selected protocol team members (users). 4. For each user in the Selected list that should have unblinded protocol level access, configure the Unblinded field as shown in the following table.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Unblinded", "definition": "Yes, to Site level for the selected region.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "views", "definition": "1. Log in to Siebel Tools. 2. Go to Business Component and query for the name Action. 3. Go to the Business Component User Properties for the Action business component. 4. Query for the name Unblinded Activity Responsibility. 5. Update the Value field for Unblinded Activity Responsibility by adding the required user roles (or responsibilities) to it. These user roles will be able to view unblinded data in Siebel Clinical core Activities and Contact Activities views. Siebel Administrator is mapped by default to the Unblinded Activity Responsibility business component user property. 207", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Position Rollup", "definition": "The position roll up hierarchy goes from Site, to Region, and then to Protocol level. \u2022 When you click Position Rollup at site level, all changes (in the Unblinded field for users at site level) will be rolled up to the region and protocol levels. \u2022 When you click Position Rollup at region level, all changes (in the Unblinded field for users at region level) will be rolled up to the protocol level. The following table shows a user's Unblinded field value after performing a Position Rollup.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Level", "definition": "User's Unblinded Field Value Position Rolldown? Unblinded Field Value After Position Rolldown", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Blinded", "definition": "Note: If Position Rolldown is performed at Region level, it does not apply since precedence is always given to the value at site level. Blinded and Unblinded Support in Siebel Mobile Disconnected Applications In Siebel Mobile disconnected applications: \u2022 Blinded users can view and access blinded site visits. \u2022 Unblinded site visits are not available. \u2022 Unblinded users can view blinded records in read-only mode irrespective of the protocol level setting Hide blinded content for unblinded users. Blinded and Unblinded Customization Support You can add new custom child applets under Site and Site visits and, if required, enable the blinding or unblinding functionality for those applets as follows: \u2022 For the business component in question, create a new Enable Unblinding user property with the value Y. \u2022 If your business component is based on the Event Activity table, then use the CSSBCClinicalGenericActivity class for your business component. Otherwise use the CSSBCClinicalGenericBusComp class for your business component. \u2022 List Applet must use the following class: CSSSWEClinicalListBase. \u2022 Form Applet must use the following class: CSSSWEClinicalFormBase. \u2022 The Business Component field must contain the following field defined on column: UNBLINDED_FLG. 213", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Position Rolldown", "definition": "The position roll down hierarchy goes from Protocol, to Region, and then to Site level. \u2022 When you click Position Rolldown at protocol level, all changes will be rolled down to all the regions and sites for the protocol. \u2022 When you click Position Rolldown at region level, all changes will be rolled down to all the sites for the region. The following table shows a user's Unblinded field value after performing a Position Rolldown.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Setting Up and Configuring Clinical Data Capture and", "definition": "Query Management System Integration 220", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CDMS Study ID", "definition": "Type the ID of the CDMS study. This required field links a clinical protocol in Siebel Clinical to a clinical study in an external application. For integration with Oracle Health Sciences InForm, set the value to the trial name in Oracle Health Sciences InForm. Synchronize Active Study Sites This field is not applicable for InForm integration.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Safety Study ID", "definition": "This field is not applicable for InForm integration.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Plan Study ID", "definition": "This field is not applicable for InForm integration. 217", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "System Integration", "definition": "\u2022 Screen Date. The customer decides which date from Oracle Health Sciences InForm to map to Screen Date in Siebel Clinical, and configures the mapping accordingly. \u2022 Informed Consent Date. Informed Consent Date is required only if a new Subject Visit Template is being applied. If Siebel Clinical does not have an informed consent date, then an Effective Date (for the Subject View Template) is sent instead of an informed consent date. About Integrating Data for Activity Completion Oracle Health Sciences InForm controls the integration of activity completion data between Siebel Clinical and Oracle Health Sciences InForm. The customer defines in the Oracle Health Sciences InForm trial what data must be collected to determine that a visit or activity in Siebel Clinical is complete. When those conditions are met, Siebel Clinical receives a message. The visit or activity is updated with the status of Complete, and the completion date is populated. If the message from Oracle Health Sciences InForm does not contain a completion date, and the visit or activity in Siebel Clinical already has a status of Complete, then no change is made to the completion date or status in Siebel Clinical. Oracle Health Sciences InForm and Siebel Clinical integrate activity completion data as follows: \u2022 Siebel Clinical searches for the subject using the unique subject identifier (row ID). When the subject is found, it searches for the activity as follows: \u25e6 Siebel Clinical searches for the activity using the clinical item for the visit and the clinical item for the visit activity as follows: - If the clinical item in the update corresponds to a subject visit, then the completed date for that visit is updated. - If the clinical item in the update corresponds to an activity for a subject visit, then the completed date for that activity is updated. \u25e6 If the clinical item sent from Oracle Health Sciences InForm cannot be mapped to an activity completion item in Siebel Clinical, then an error is generated to indicate that the update failed. 225", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Setting Up and Using the Siebel Mobile Disconnected", "definition": "Application for Siebel Clinical Viewing Site Visits Information Complete the following procedure to view the visits associated with a site. To view site visit information 1. Tap Side Menu on the application banner, and then tap My Site Visits to display the following: \u25e6 The My Sites list in the side pane. \u25e6 The site details in the main pane. 2. Tap a record in the My Sites list. All the site details for the selected record appear. 3. Tap the down arrow next to Site Visits. All the visits associated with the selected site appear. 240", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Component", "definition": "eClinical Mobile Data Extraction (ENU) 228", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ENU", "definition": "OM - Configuration File eclinicalm.cfg Application Splashtext Siebel Clinical Mobile", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Application Title", "definition": "Siebel Clinical Mobile c. Click Activate to activate the new eClinical Mobile Data Extraction (ENU) component. d. Click Synchronize to synchronize the eClinical Mobile Data Extraction (ENU) component 3. Navigate to the Synchronize view, and click Synchronize. 4. Navigate to the Component Definition view, and do the following: a. Select the eClinicalMObjMgr_enu component and set the following parameters for the component:", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "MobileSync", "definition": "c. For each of these component groups: - Select the component group and then click Enable. - In the Component Group Assignments applet, click Enable. 5. Restart Siebel Services and Siebel Gateway. 6. Navigate to the Administration - Server Management screen, then the Jobs view and do the following: a. Create a new job with the parameter values shown in the following table:", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Job Parameter", "definition": "Value: -MOBILE b. Submit the job. The status of the job changes to Success when the database extraction job is successful. One-Time Activity for Customers with existing Site Visit Records Note: Check if you meet the following three criteria: 1. You are upgrading to the 24.4 release 2. Planning to use the Mobile Disconnected Application 3. Have existing Site Visit records Then, there is a mandatory one-time activity required to update the Page_id on existing Site Visits In order to use the mobile app. To update the existing Site Visit records 1. Log in as an Admin user to Siebel Clinical. 2. Navigate to Administration > Server Management. a. In the Job list, click New 230", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Answering a Question", "definition": "\u2022 Click to enter or update a response to the question. \u2022 Free text comments can be entered in the Comments field, if needed. \u25e6", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Saving a response", "definition": "\u2022 Answers are auto-saved by the app when a user performs any of the following actions: - Navigating to the next question - Navigate to the previous question - Jump to another question in Navigation Tree - Click on the Finish button Note: Clicking only on the Cancel button will result in potential unsaved data changes be lost and user to be exited from the SmartScript player. \u25e6 Validation on mandatory questions \u2022 For mandatory questions, a pop-up message will be presented if you do the following: - Navigate (next, previous, or jumping) away from a mandatory question that has not been answered. - Click on Finish to complete the trip report and exit the SmartScript Player. \u25e6 Completing questions and exiting the SmartScript Player \u2022 A user can exit the Smartscipt player with the following choices: - Click on Finish to save and exit the SmartScript player. Finish will trigger validation to ensure that all mandatory fields have been completed across questions in the Site Visit before saving and exiting. - Click on Finish Later to save any unsaved changes and exit the SmartScript player. Finish Later will not trigger validation of mandatory questions. - Click on Cancel to exit the SmartScript player. Note: Any unsaved changes will be lost. Managing My Sites for Siebel Clinical A site is an account that a principal investigator manages for a particular protocol. The following procedures related to site management are included in this topic: \u2022 Displaying My Sites Information \u2022 Viewing Site Contacts Information \u2022 Viewing Site Visits Information 238", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Setting Up Integration Between CTMS and eTMF", "definition": "This task is a step in Process of Setting Up Integration Between CTMS and eTMF. To manually generate a trip report file 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. Query for the approved site visit that you want (where the trip report file failed to generate). 3. Click Generate Report. A trip report file is generated with a status of Approved and it is automatically added to the Site Visit Attachment", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "TR File Type", "definition": "The default file naming convention for the trip report file is as follows: \u25e6 TR File Name: ___Row ID \u25e6 TR File Type: PDF TR File Name = ___Row ID Configuring Email Recipients When an approved trip report file is automatically added to the Site Visit Attachment view, an email is sent to key CRA and eTMF recipients notifying them that an approved trip report file is ready to send to the eTMF system. The following procedure shows you how to configure the email recipients. This task is a step in Process of Setting Up Integration Between CTMS and eTMF. To configure email recipients 1. Navigate to the Administration - Application screen, then the System Preferences view. 243", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SMTP Server Port", "definition": "Configuring the LS Clinical Trip Report File Web Service The eTMF system calls the LS Clinical Trip Report File Transfer Web service (an inbound SOAP Web service provided by CTMS) to pull the trip report file into the system and in turn send the trip report received date and URL link from eTMF back to CTMS. To pull a specific trip report or a group of trip reports from CTMS into the eTMF system, then configure one or more of the input parameters, as listed in the following procedure, in the LS Clinical Trip Report File Transfer Web service. This task is a step in Process of Setting Up Integration Between CTMS and eTMF. 244", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Trip Report ID", "definition": "The ID associated with the trip report.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Approved Date", "definition": "The date the trip report was approved. Manually Generating Trip Report Files If for some reason a trip report file is not generated automatically once a site visit is approved (this is usually due to BI Publisher not working), then a notification is sent to the concerned team members notifying them of the situation and the Generate Report button on the Site Visits screen is activated. You configure the team members to notify (upon failure to generate a trip report file once a site visit is approved) in the BC user property BIP Error Notification List. The values you can assign to BIP Error Notification List are Approver, Reviewer, Primary, and Team. The default value is Primary and a maximum of two values can be configured. For example: Approver, Reviewer. 245", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "One", "definition": "Configuring Enterprise Level Parameter Add the following enterprise parameter: 1. Navigate to Administration->Server Configuration->Enterprises->Parameter. 2. Search for Enterprise Parameter Name = 'Business Service Query Access List'. 3. Append the following value for this parameter: Workflow Process Manager,LS Clinical Subjects Rest Service If a value already exists, append the new value after the comma and without a space. 4. Restart the Siebel environment. Disabling User Properties If you are using this integration, you need to disable the following user properties to avoid deletion of future visits when subject is screen failed or early terminated: BC: Clinical Subject Status User Property to Inactivate: \u2022 LS Subject Terminate Study Status Value 1 \u2022 LS Subject Terminate Study Status Value 2 Enabling Auto Apply SVT A new button is added in 'Site Management->Protocol Site->Clinical Subject' to apply the new/updated subject template to all subjects in one action. The batch apply feature is a new option in addition to the ability to apply the subject template to one subject at a time. Out-of-the-box, the functionality of Apply SVT is available with the 'Siebel Administrator' Responsibility. If this functionality is required for any additional responsibility, it can be provided in the 'CL - Apply SVT Access' System Preference as a comma separated list. 250", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "EDC Item Library", "definition": "The \u201cLS Clinical EDC Item Library View\u201d is available under Administration - Clinical -> Visit Templates. When a new SVT is inserted using APIs in Siebel Clinical, as part of the process the unique Activities (identified by Clinical Item + Form Id) are inserted under the \u201cEDC Item Mapping\u201d view from each Template Version.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Refresh Activity", "definition": "This button is available at Administration Clinical->Visit Templates->Template Versions. 247", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Setting Up Integration Logging", "definition": "Configuring Email Notifications You can configure the Email notifications to be notified in case of errors in log and log purging. Once the Study is successfully enabled for logging, do the following: 1. Check (enable) the Notify flag for the respective integrated system on the Integration Systems List applet. 2. Enter the Email address to which the notifications are required to be sent. Note: Multiple Email addresses can be entered separated by semicolon (;). Configuring the Attributes You can add the following preferences/attributes: Integration Log Email Profile- You can create your own Email profile, see section Creating a Communication Profile. 1. Click + button on the Attributes List applet. 2. Enter the Name of the profile and enter the Value. Integration Log Email Template Failure- You can create an Email template for all log failure notifications. 1. Create an Email template by navigating to Administration - Communications > Templates. 2. After successful creation of the template, click on the+ button on the Attributes List applet. 3. Enter the Name and value of the template. Integration Log Email Template Success- You can create an Email template for all the successful log notifications. 1. Create an Email template by navigating to Administration - Communications > Templates. 2. After successful creation of the template, click on the+ button on the Attributes List applet. 3. Enter the Name and value of the template. Configuring the Logs Purge Process You can configure the number of days for which the logs are required to be retained by the CTMS system after which they will be purged. Enter a value in days. For example, if 10 is entered under the Value, all the logs created from current system date shall be purged after 10 days from the system date. 1. Navigate to Administration - Clinical > Integration Administration. 2. From the drop down, select Integration Systems. 3. Under the Attributes for the Purge Log Cutoff Days, under value add a number in days in order the system to wait for the given number of days and then to purge the logs. 252", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Developer\u2019s Reference for Siebel Clinical", "definition": "Request Message: ClinicalTripReportFileTransferQueryPage The following table describes the ClinicalTripReportFileTransferQueryPage request message. SWILSClinicalTripReportFileTransfer Operations The following table lists the operations associated with the SWILSClinicalTripReportFileTransfer Web service.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Date VBC", "definition": "This property defines the workflow process that is invoked when the Enroll Screen Rescreen Through WorkFlow property is set to Y. The default value is LS Clinical - SubjectVisits Process. This workflow process applies the approved subject visit template to the subject. If the subject visit template that is applied is different from the previous version of the subject visit template that was applied, and if the Disable Delete Non App Visit property is set to N, then a pop-up message appears to confirm if incomplete visits in the previous template version must be deleted, and if complete visits in the new template version must be deleted. Clicking OK in the pop-up message deletes the non applicable subject visits. Clicking Cancel retains the non applicable subject visits. User Properties for Business Services in Siebel Clinical The following table describes the business service user properties that you can use to enable and configure functionality for Siebel Clinical.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Visit Plan", "definition": "This property configures automatic status tracking. The value is set to Missed. 259", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Trip Report", "definition": "LS Clinical VAT Amount Rollup", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Date RollUp", "definition": "Fields:Protocol n Clinical Protocol Site This property configures automatic rollup of the Last Subject Off Study date from the site record to the protocol record. The value takes the following parameters: \"\", \"\", \"\" The value is set as follows: \"Last Subject Off Study Date\", \"Last Subject Off StudyDate\", \"(DESCENDING)\" Note: Do not change this value. Date RollUp Fields:Region", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Protocol Site", "definition": "This property configures automatic rollup of the Last Subject Off Study date from the site record to the region record. The value takes the following parameters: \"\", \"\", \"\" The value is set as follows: \"Last Subject Off Study Date\", \"Last Subject Off Study Date\", \"(DESCENDING)\" Note: Do not change this value. Delete NonApp WorkFlow", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Subject", "definition": "LS Clinical State Validation Third-party payments application integration LS Clinical Total Contract Amount Rollup Clinical operations integration LS Clinical Training Implementation", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "WorkFlow Process Name", "definition": "\u2022 Apply Templates WorkFlow Process Name \u2022 Delete NonApp WorkFlow Process Name Last Subject Off Study", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Date Rollup Status n", "definition": "Clinical Protocol Site This property identifies the qualified subject statuses that are used to populate the date in the Last Subject Off Study field. By default the following statuses are set: \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Payments", "definition": "LS Clinical Payments Outbound Third-party payments application integration 279", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Study Status Value 1", "definition": "Clinical Subject Status This property turns on or off the deletion of incomplete future visits for a subject. These incomplete visits are visits for which the date associated with the subject status has a value, the Completed field for the visit is not selected, and the date in the Date field of the visit is later than the date associated with the subject status. When enabled, the incomplete future visits are deleted if the status of the subject is a value in this property. By default, this property includes the following values: \u2022", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Named Method 1", "definition": "Action (No Owner Lock) This property generates payment records. The value string is set as follows: \"GenerateNewPayment\", \"INVOKESVC\", \"Action(No Owner Lock)\", \"LS SubjectVisits Service\", \"GeneratePayment\", \"'Site Id'\", \"[Protocol Site Id]\", \"'srcBusComp'\", \"'Action (No Owner Lock)'\", \"'srcBusObj'\", \"'Clinical Protocol Site'\", \"'tgtBusObj'\", \"'Clinical Payments'\", \"'tgtBusComp'\", \"'Clinical Payments'\" Note: Do not change this value.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Status Snapshot", "definition": "This property generates the subject status snapshot for a clinical site. The value string is set as follows: \"SiteSnap\", \"INVOKESVC\", \"LS Clinical Subject Status Snapshot\", \"LS Clinical Trip Report Svc\", \"GetSiteSnapshot\", '\"SVId\"', \"ParentFieldValue('Id')\" Note: Do not change this value.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "for Popup", "definition": "This property associates accounts, activities, and documents for clinical protocols and clinical regions with sites. It specifies the method (for example, ProtocolAccountRolldownToSite) for the appropriate popup applet, the underlying business component (Clinical Protocol Site for Popup) for that applet, the method (ApplyRolldown) in that business component that calls the rolldown business service (LS Clinical Record Rolldown Service), and the appropriate user property (for example, Protocol Account To Site Rolldown) as the input argument for the business service. To associate accounts for clinical protocols with sites, set the value string as follows: \"ProtocolAccountRolldownToSite\", \"INVOKESVC\", \"Clinical Protocol Site for Popup\", \"LS Clinical Record Rolldown Service\", \"ApplyRolldown\", \"UserPropertyName\", \"Protocol Account To Site Rolldown\" To associate accounts for clinical regions with sites, set the value string as follows: \"RegionAccountRolldownToSite\", \"INVOKESVC\", \"Clinical Protocol Site for Popup\", \"LS Clinical Record Rolldown Service\", \"ApplyRolldown\", \"UserPropertyName\", \"Region Account To Site Rolldown\" To associate activities for clinical protocols with sites, set the value string as follows: \"ProtocolActivityRolldownToSite\", \"INVOKESVC\", \"Clinical Protocol Site for Popup\", \"LS Clinical Record Rolldown Service\", \"ApplyRolldown\", \"UserPropertyName\", \"Protocol Activity To Site Rolldown\" To associate activities for clinical regions with sites, set the value string as follows: \"RegionActivityRolldownToSite\", \"INVOKESVC\", \"Clinical Protocol Site for Popup\", \"LS Clinical Record Rolldown Service\", \"ApplyRolldown\", \"UserPropertyName\", \"Region Activity To Site Rolldown\" To associate documents for clinical protocols with sites, set the value string as follows: \"ProtocolDocumentRolldownToSite\", \"INVOKESVC\", \"Clinical Protocol Site for Popup\", \"LS Clinical Record Rolldown Service\", \"ApplyRolldown\", \"UserPropertyName\", \"Protocol Document To Site Rolldown\" To associate documents for clinical regions with sites, set the value string as follows: \"RegionDocumentRolldownToSite\", \"INVOKESVC\", \"Clinical Protocol Site for Popup\", \"LS Clinical Record Rolldown Service\", \"ApplyRolldown\", \"UserPropertyName\", \"Region 261", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Status Field RollUp n", "definition": "Clinical Subject Status This property collates subject numbers for each status value. You can also configure it to collate subjects status and visit type value pairs. The subject accruals data is rolled up to the site record. The following comma-delimited parameter configurations are supported: \u2022 \"[Subject Status]\", \"[Business Component Field Name]\", \"[Visit Type]\" \u2022 \"[Subject Status]\", \"[Business Component Field Name]\", \"[Null]\" \u2022 \"[Subject Status]\", \"[Business Component Field Name]\" The Subject Status and Business Component Field Name parameters are mandatory. The Visit Type parameter is optional. The Visit Type value is not populated by default. The following example provides the default configuration for the Enrolled status, and collates the subjects with an Enrolled status for automatic rollup to the site record: \"Enrolled\", \"# Enrolled\"", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Status RollUp", "definition": "Fields:Region n Clinical Protocol Site This property collates subject numbers for each status value. You can also configure it to collate subject status and visit type value pairs. The subject accruals data is rolled up to the region record. The following comma-delimited parameter configurations are supported: \u2022 \"[Subject Status]\", \"[Business Component Field Name]\" \u2022 \"[Subject Status]\", \"[Business Component Field Name]\", \"[Visit Type]\" \u2022 \"[Subject Status]\", \"[Business Component Field Name]\", \"[Null]\" 262", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Enhancement", "definition": "This property configures rollup of subject status data to sites, regions, and protocols. Configure the value as follows: \u2022 To enable this property, set the value to Y. \u2022 To disable this property, set the value to N. This property is enabled by default. Protocol Account To Site", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "LS Clinical Admin", "definition": "This property associates documents for clinical regions with sites. It specifies the data map information in the form of an input argument for the business service method. The named method property for the underlying business component calls this business service when you click the OK button in the LS Clinical Region Document Site Popup applet. This applet appears when you click the Apply To Sites button in the Document Tracking view of the Region screen. The default value for this property follows: 'LS Clinical Region Document To Sites', 'LS Document Tracking', 'Id', 'Clinical Protocol Site for Popup', 'Id' In this value, LS Clinical Region Document To Sites is a data map that maps the fields in documents for regions to the fields in documents for sites, LS Document Tracking is the name of the source business component, and Clinical Protocol Site for Popup is the name of the underlying business component for the LS Clinical Region Document Site Popup applet. Id is a field that uniquely identifies a document in the source business component and a site in the business component for the popup applet. You can change the field mapping for data maps in the Data Component list in the Data Map Administration view of the Administration - Application screen. For more information about changing data maps, see Siebel Order Management Infrastructure Guide . You can configure additional properties for the LS Clinical Record Rolldown Service business service to set up additional functionality for rolldowns. An example of such a custom property follows: 'Custom Data Map', 'Source Business Component', 'Id', 'Business Component for the Popup Applet', 'Id' In this value, Custom Data Map is a data map that maps the fields in the source business component to the fields in the target business component, Id is a field that uniquely identifies a record in the source business component and a record in the underlying business component for the popup applet. The named method property for the underlying business component calls this business service when you click the OK button in the appropriate popup applet. The value for the named method property specifies the method for the appropriate popup applet, the underlying business component for that applet, the method in that business component that calls the rolldown business service, and the appropriate user property as the input argument for the business service. An example of such a custom property follows: 269", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ClosePopUp", "definition": "LS Clinical Protocol Account Site", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Popup Applet", "definition": "This property configures notifications for bulk payments by specifying the value for the Severity field that is passed as an input argument to the workflow that the GenerateBulkPayment method calls when you click the OK button in the LS Clinical Site Bulk Payment Applet. This applet appears when you click the Generate Payment button in the Payments view of the Protocols screen or the Regions screen. The input argument is a key-value combination. An example follows: Severity=\"Normal\" This example shows the default value for this property, but you can change this value to any value for the Severity field that has a Type field value of BRDCST_MSG_TYPE in the list of values and that is active in the list of values. Alternate values include: High, Urgent, and Urgent with Alert. For applets that are associated with the CSSSWEFrRolePopup class and that have Clinical Protocol Site Bulk Operations as the underlying business component, you can create additional input arguments for the workflow that the GenerateBulkPayment method calls by creating additional applet properties as WF.field name , and recompiling the applet. For example, a custom property of WF.CustomerName might have the following input argument for the workflow: CustomerName=\"Elixir Labs\" Field Properties in Siebel Clinical The following information lists the field properties that you can use to enable and configure functionality for Siebel Clinical. 274", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Site Popup Applet", "definition": "This property closes the pop-up applet when an end user performs an action to close this applet, such as clicking the OK button. This action calls the method in the value for this property. You can enter a comma-delimited list in this property to specify multiple methods. An example follows: ClosePopUp=\"method 1\", \"method 2\", \"method 3\" The default value (method name) for each of the six applets follows: \u2022 ProtocolAccountRolldownToSite \u2022 ProtocolActivityRolldownToSite \u2022 ProtocolDocumentRolldownToSite \u2022 RegionAccountRolldownToSite \u2022 RegionActivityRolldownToSite \u2022 RegionDocumentRolldownToSite You can use this property in applets that are associated with the CSSSWEFrRolePopup class.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "HideInQueryMode", "definition": "Any applet that uses one of the following classes or a class derived from these classes: CSSSWEClinicalList Base CSSSWEClinicalForm Base This property hides the buttons that call the methods in this property. This property hides these buttons when end users click Query in the applet. You can enter a comma-delimited list in this property to specify multiple methods. An example follows: HideInQueryMode=\"ShowAll\", \"ShowCurrent\", \"CallCustomerMaster\" If the button calls the ShowPopup method, you do not have to include that method in this property.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "History Target BC", "definition": "(Internal) Clinical Protocol Team Mvg", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Applet", "definition": "This property specifies the target business component. The default values follow: \u2022 Clinical Protocol Site Team Assignment History BC \u2022 Clinical Protocol Team Assignment History BC 270", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Version Assoc Applet", "definition": "This property configures the versions of the subject visit template that appear in the Site Management Versions MVG (multi value group). Configure this property as follows: \u2022 To display only the versions of the subject visit templates with a status of Approved, set the value as follows: [Status Cd] = LookupValue(\"CLNCL_VERSION_ STATUS\",\"Approved\") \u2022 To display the versions of the subject visit templates with a status of Reviewed or Approved, set the value as follows: [Status Cd] = LookupValue(\"CLNCL_VERSION_ STATUS\",\"Approved\") OR [Status Cd] = LookupValue(\"CLNCL_VERSION_STATUS\",\" Reviewed\") The default configuration displays only subject visit templates with a status of Approved in the Site Management Versions MVG.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Popup Visibility Type", "definition": "LS Clinical Site Bulk Payment", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Catalog", "definition": "View modes determine the records that end users can see in a view that is associated with an underlying business component. For example, if you set this property value to Organization, then the end user who clicks the Generate button can see the site records for the protocol or region that are associated with the organization of the end user. This property overrides the pop-up visibility of the underlying business component. The underlying business component must support the view mode associated with the value that you enter. For more information about view modes, see Siebel Security Guide . 271", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Divisions", "definition": "LS Clinical Site Bulk Payment", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Positions", "definition": "LS Clinical Site Bulk Payment", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Rescreen Date", "definition": "Note: This property is deprecated in version 8.1.1.9 and later. This property configures the subject visit template type that is used when applying a template. The default property value for each parent field follows: Enrollment Date = \u2018Enrollment\u2019 Screen Date = \u2018Screening\u2019 Rescreen Date =\u2018Re-Screening\u2019 System Preferences in Siebel Clinical The following table lists the system preferences that you can use to configure core functionality in Siebel Clinical Trial Management System and to integrate Siebel Clinical Trial Management System with third-party applications. 275", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Screen Date", "definition": "This property configures whether or not subject informed consent is mandatory when scheduling a clinical subject. When enabled, the Informed Consent Date field is checked for data when the user clicks Schedule. Configure this property as follows: \u2022 To set the Informed Consent Date as a mandatory field when scheduling a clinical subject, set the value to Y. \u2022 To set the Informed Consent Date as an optional field when scheduling a clinical subject, set the value to N. The default value is N. Template Type Code]", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Functionality", "definition": "The user can set the value to either Y or N. If the value is set to Y, the system won't create the CRF records during scheduling of the Subject. If the value is set to N, the system creates the CRF records during Subject scheduling. The default value must be set to N. CL- Enable C1 integration This setting helps the user to decide whether the CTMS application is integrated with Clinical One application. The user can set the value to either Y or N. If the value is set to Y, it means that the CTMS application is integrated with Clinical One application. If the value is set to N, it means there's no integration. The default value must be set to N. Workflows in Siebel Clinical The following information lists the required workflows for Siebel Clinical core functionality and for integrating Siebel Clinical with third-party applications. For more information about each workflow, see the corresponding functional area in this guide. You can use Siebel Business Process Designer to modify the workflows to suit your own business model. For information about configuring workflows, see Siebel Business Process Framework: Workflow Guide .", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Workflow Name", "definition": "Siebel Clinical Functionality SWI LS Clinical Subject Inbound - Subject Clinical data management system integration SWI LS Clinical Subject Inbound Clinical data management system integration SWI - Protocol Number Lookup Clinical data management system integration Web Services in Siebel Clinical You can customize the Web services in Siebel Clinical for integration with any third-party clinical application or for specific business requirements. The following information lists the Web services for mobile and external application integration. For more information about each Web service, see the corresponding integration chapter in this guide. For information about customizing Web services, see Siebel CRM Web Services Reference .", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Site", "definition": "LS Clinical Site Subject Delete Accruals", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Template", "definition": "LS Clinical - DeleteNonAppVisits Process Clinical Subject Visits LS Clinical - SubjectVisits Process Clinical Subject Visits LS Clinical Contract Rollup", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Contract", "definition": "LS Clinical Create Inbox Item for New Trip", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Clinical Training", "definition": "LS Clinical Trip Report Approval", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "NewSite", "definition": "Site visit data integration LS ClinicalProtocolSite Outbound -", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Location", "definition": "Site visit data integration SWI LS Clinical Payments Inbound Third-party payments application integration SWI LS Clinical Query Protocol Site_Site", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "ClinicalSubject", "definition": "Clinical data capture integration LS Clinical CRF Tracking Interface Clinical operations integration LS Clinical Protocol Site Interface Service Clinical data capture integration Clinical operations integration LS Clinical Subject Information Interface", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Service", "definition": "CTMS and eTMF integration SWI LS Clinical Payments Inbound Payments application integration SWILSClinicalActivityTemplate", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Mobile integration", "definition": "SWILSClinicalTripReportFileTransfer Web Service This Web service is used to send out trip report details to external applications and to update the trip report details in CTMS. Operations supported to query the trip report details are Query, QueryPage, and Upsert. Operations supported to alter the trip report are Query, Query Page, and Insert or Update. Whoever invokes this Web service must be a member of the site visit team. External applications can invoke this Web service with any methods. Mobile application users can also use this Web service to update trip reports offline. For more information about using the SWILSClinicalTripReportFileTransfer Web service, see the following topics: \u2022 SWILSClinicalTripReportFileTransfer Operations \u2022 Request Message for TripReportFileTransferQuery \u2022 Request Message for ClinicalTripReportFileTransferQueryPage \u2022 Request Message for TripReportFileTransferUpsert \u2022 Response Message for SWILSClinicalTripReportFileTransfer \u2022 SWILSClinicalTripReportFileTransfer Application Interface 282", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Optional", "definition": "SWILSClinicalTripReportFileTransfer Application Interface The topic describes the application interface for SWILSClinicalTripReportFileTransfer. The following application objects are called by the SWILSClinicalTripReportFileTransfer Web service: \u2022 Service Object (Business Service or Workflow) \u2022 Data Object (Integration Object) For more information on application implementation, refer to your application development documentation on Oracle Technology Network. Service Object (Business Service or Workflow) The following table describes the service object for SWILSClinicalTripReportFileTransfer.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Class", "definition": "LS Clinical Trip Report File Transfer", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Business Service", "definition": "CSSEAISiebelAdapterService Data Object (Integration Object) The following table describes the data object for SWILSClinicalTripReportFileTransfer.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "External Name", "definition": "LS Clinical Trip Report File Transfer", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "systems", "definition": "Configuration of Bearer Token Authentication in Siebel", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PowerTrials systems", "definition": "Setting Up Integration Between CTMS and PowerTrials This chapter describes how to integrate CTMS with PowerTrials system. It includes the following topics: \u2022 Overview of Integration Between CTMS and PowerTrials \u2022 CTMS and PowerTrials Integration Process Flow \u2022 Process of Setting Up Integration Between CTMS and PowerTrials \u2022 Configuring Email Recipients \u2022 Configuration of Bearer Token Authentication in Siebel CTMS \u2022 Setup and Configuration of Billing Grid Designation and SVT Mandatory Fields Overview of Integration Between CTMS and PowerTrials For customers using Siebel CTMS and Oracle Health PowerTrials, the primary goal of the outbound integration is to securely automate the creation, update, or sharing of records in one system to flow into the other. The new integration between CTMS and PowerTrials will leverage standard APIs in PowerTrials based upon the Retrieve Protocol for Execution (RPE) specifications with optional uptake by new or existing customers who have PowerTrials. It is delivered via new SOAP-based APIs and new security responsibilities for restricting access to sensitive patient records. Following are some terminologies: \u2022 PROTOCOL: A PowerTrials integration enabled Protocol in CTMS can trigger a workflow to create and update information with a minimum set of configurable fields in CTMS over to PowerTrials. \u2022 PATIENT / SUBJECT: A new controlled Patient screen in CTMS will allow controlled access to research site for users with the ability to link patients to be identified as a subject in a Protocol to trigger the enrollment and updates of subject details from CTMS over to PowerTrials. \u2022 SUBJECT VISIT TEMPLATE (SVT): A PowerTrials integration enabled Protocol in CTMS can securely automate the creation, update, or sharing of Subject Visit Template records containing billing details over to PowerTrials. CTMS and PowerTrials Integration Process Flow CTMS provides a outbound API to support pushing protocol/subject/SVT details from CTMS to PowerTrials. Patient/Subject, Protocol, and SVT details are pushed from CTMS to PowerTrials systems via outbound APIs. 291", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Add Proxy settings", "definition": "Add Proxy in setenv.sh under applicationcontainer_internal/bin. Command: CATALINA_OPTS=\"-Dhttp.proxySet=true -Dhttps.proxySet=true - Dhttps.proxyHost=www-proxy.us.oracle.com -Dhttps.proxyPort=80 -Dhttp.proxyHost=www- proxy.us.oracle.com -Dhttp.proxyPort=80 - Djavax.net.ssl.trustStore=/u01/siebel/ses/applicationcontainer_internal/siebelcerts/siebelkeystore.jks - Djavax.net.ssl.trustStorePassword=siebel - Djavax.net.ssl.keyStore=/u01/siebel /ses/applicationcontainer_internal/siebelcerts/siebelkeystore.jks - Djavax.net.ssl.keyStorePassword=siebel\" Path for Cloud customers: /u01/siebel/ ses/applicationcontainer_internal/siebelcerts/siebelkeystore.jks - Djavax.net.ssl.trustStorePassword=siebel - Djavax.net.ssl.keyStore=/ u01/siebel /ses/applicationcontainer_internal/siebelcerts/siebelkeystore.jks - Djavax.net.ssl.keyStorePassword=siebel\" For Cloud Customers and for Multi-Server Setup Use any GW Cluster node in the OURBOUNDSHA2 profile jbs parameter as shown below for multi-server setup. 1. Navigate to Administration > Server Configuration > Enterprise Profile. 2. Query for Profile OUTBOUNDSHA2 and change container URL. Note: To avoid the burden on primary and secondary cluster nodes, preferably use the third GW cluster node. 293", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "For Non-ENU customers", "definition": "1. In Siebel Web Tools, navigate to Workflow, search for name LS Clinical Protocol Synchronization. Under Create Log Step, change the input argument Wf Run Status value to IIF([&ResponseValue] = 'Failure', LookupValue (\"LSCL_INT_STATUS\", \"ERROR\"), LookupValue (\"LSCL_INT_STATUS\", \"SUCCESSFUL\")) . 2. In Siebel Web Tools, navigate to Workflow Query for LS Clinical Create Integration Log. a. In Log Error condition decision step update expression value to \u2018Wf Run Status\u2019 value to \u2018([&Log Level]=LookupValue(\"LSCL_INT_LOG_LEVEL\", \"ENABLE\")) OR ( [&Wf Run Status] = LookupValue(\"LSCL_INT_STATUS\", \"ERROR\") AND [&Direction] = LookupValue(\"LSCL_INT_DIRECTION\", \"OUTBOUND\")) b. In Inbound condition decision step update expression value to ([&Direction] = LookupValue(\"LSCL_INT_DIRECTION\", \"INBOUND\") OR ([&Direction] = LookupValue(\"LSCL_INT_DIRECTION\", \"OUTBOUND\") AND [&OperationType] \"Retry\")) 3. Navigate to Administartion-Integration under Data Map Editor, search for LS Clinical PT Protocol and then for name code6 under Integration Component Map. Remove Source Search Specification value that is already provided. 294", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CTMS", "definition": "To configure bearer token authentication in Siebel CTMS 1. Authentication Details: A Bearer token (encrypted System Account) needs to be configured for authentication in Siebel CTMS. This token will be authenticated by PowerTrial. 2. System Account Creation: The required System Account will be created in Cerner. 3. Siebel Configuration: a. Navigate to Siebel Web Tools. b. Locate the Clinical Protocol Business Component. c. Under the Business Component, go to User Properties, search for a user property named Token. d. In the Value field of the Token User Property, add the encrypted value of the System Account. e. Navigate to SIEBSRVR_ROOT\\bin, encryptstring systemaccount to set up encryption. 4. To send a request from CTMS to PowerTrail without Bearer token Authentication, the user property Token must be set to null. Setup and Configuration of Billing Grid Designation and", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SVT Mandatory Fields", "definition": "To setup and configure Billing Grid Designation and SVT mandatory fileds: 1. Go to Administration \u2013 Clinical > Integration Administration > Integration Systems > Attributes. You can add PT SVT Mandatory Fields and PT SVT Billing Grid Designation. Note: \u25e6 You can define the mandatory fields needed for SVT integration. \u25e6 You can define the values for the Billing Grid designation. 295", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Missed Milestones", "definition": "To setup the milestone Email alerts, you need to create a job and Email profile as described: You can configure email alerts for approaching milestone completion dates. 1. Create a new job as Workflow Process Batch Manager under Jobs. 2. You can configure the job details like \u201cRepeat Interval\u201d, \u201cScheduled Start\u201d, \u201cRepeat Unit\u201d, and other details. 3. Add under the Job Parameters, select Name as Workflow Process Name and enter value as LS Clinical Milestone Activity Alert Email. 4. Add a Job Parameter Search Specification and set it to: ([Actual Date] IS NULL AND [Category] = \"Milestone\" AND ([Due Approach] = \"Y\" OR [Due Crossed] = \"Y\")). This condition will pick the Milestones that are either approaching the due date or past the due date. 5. Add an email profile name as Milestone Activity Alert Email Profile. 6. Set appropriate profile parameters for your environment. For more information on setting up an Email Profile, refer to, Email Administration Guide in Siebel Bookshelf. 301", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Effective End Date", "definition": "\u25e6 Status (defaults to \u2018Draft\u2019 for a new version) State transitions: Draft > Reviewed Reviewed > Active Active > Archived Archived > Active Note: \u25e6 In Draft status, you can manually enter, update or import Charge Sheet Items into a Charge Sheet Version. \u25e6 When status is set to \u2018Reviewed\u2019 the Reviewed by is auto-populated. \u25e6 When status is set to \u2018Active\u2019 the \u2018Activated By\u2019 is auto-populated. Importing Charge Sheet Items To Import records to a Charge Sheet version: 1. Click on the Import button. 2. You can see a pop-up window to browse for a comma separated value (.csv) following the Charge Sheet import format. Refer to the table for Charge Sheet IO: Charge_ Sheet_ Version.Version Charge_ Sheet_ Version.Currency Charge_ Sheet_ Code.Code Charge_ Sheet_ Code.Name Charge_ Sheet_ Code.Code", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Fee", "definition": "Charge_ Sheet_ Code.Category Charge_ Sheet_ Code.Category", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Subtype", "definition": "Charge_ Sheet_ Code.Comments Charge_ Sheet_ Code.Code", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CT", "definition": "Teston1058updTestCodeDescupd Managing a Charge Sheet Versions Following are the actions that you can perform when working on a Charge Sheet Version: Charge Sheet Version state", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Actions", "definition": "Draft/Reviewed \u2022 Can delete Sheet version \u2022 Edit sheet version attributes \u2022 Manual entry or import Charge Sheet version items (records)", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Archived", "definition": "\u2022 Cannot delete, edit, import any records \u2022 Effective End date is mandatory Assigning Charge Sheet to Subject Visit Template 1. Under Administration Clinical, go to Visit Template. 305", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Template Version", "definition": "b. Subject Visit Template Version level: - You can select from \u2018Active\u2019 Charge Sheet Versions only and set it to a version different from the Master Visit Template. Assigning CPT Codes and Billing Designation to SVT", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PII Business Service", "definition": "Siebel CTMS utilizes the Siebel AI framework to identify Personally Identifiable Information (PII) across various business components. It achieves this by calling the SiebelClinicalOCIAIService within the Clinical class code, which connects to Oracle Cloud Infrastructure (OCI) AI services for text analysis.This functionality is configurable and can be extended to other components based on customer requirements. 308", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Masking", "definition": "Siebel Administrators can setup a configuration to mask the PII information automatically under the Business Component User Properties. You can add a property for \u2018modifyText\u2019 and when set to true, the text where PII information is suspected can be masked. Siebel Developers can also configure the masking character that they would like to use for masking the PII information under the Business Component User Properties. You can add a configuration, \u2018maskingCharacter:\u2019. For example, you can set the \u2018maskingCharacter:*\u2019 where the text is masked with \u2018*\u2019.", "sources": [ "clinical-trial-management-system-guide.pdf" ], "source": "clinical-trial-management-system-guide.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "CLINICAL RESEARCH", "definition": "Glossary of Terms and De\ufb01ni\u019fons FDA-NIH Clinical Research Working Group Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 1 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG Introduc\u019fon: The U.S. Food and Drug Administra\u019fon and the Na\u019fonal Ins\u019ftutes of Health (NIH) Joint Leadership Council convened a working group to bring clarity to terms that are inconsistently used within the scien\u019f\ufb01c community. Working together with the goals of improving communica\u019fon and scien\u019f\ufb01c understanding, the two agencies developed a glossary with de\ufb01ni\u019fons of terms used in clinical research. To ful\ufb01ll their charge, the FDA-NIH Clinical Research Working Group (CRWG) developed de\ufb01ni\u019fons for 37 clinical research terms related to innova\u019fve clinical study designs, including studies using real-world data (RWD) to generate real-world evidence (RWE), that support scien\u019f\ufb01c, clinical, and/or regulatory decision-making. In addi\u019fon, 8 terms are included for reference and FDA-NIH are not seeking comment on these 8 terms. The membership of the FDA-NIH CRWG consisted of sta\u019fs\u019fcians, epidemiologists, pharmacologists, clinicians, biomedical engineers, and policy experts from both agencies. This document is intended to facilitate communica\u019fon within the clinical research community, by helping establish a common vocabulary to more uniformly characterize clinical research, including innova\u019fve trial designs and studies using RWD to generate RWE. In turn, the community may be beter situated to evaluate poten\u019fal strengths and weaknesses of individual studies, and to convey innova\u019fve and other aspects of clinical research in a meaningful way to funders, reviewers, and other interested par\u019fes. Terms in the glossary are grouped into the following two areas: 1. Terms for Comment: These terms include approaches to clinical study design, methodology, and interpreta\u019fon and descrip\u019fon of research results. Where an exis\u019fng de\ufb01ni\u019fon is used or adapted, the source(s) are listed. 2. Terms for Reference: These are terms with well-established de\ufb01ni\u019fons (e.g., well-established in the scien\u019f\ufb01c community) included for completeness and are not newly de\ufb01ned with this project. They are included as Appendix A to add context for the terms the FDA-NIH CRWG have de\ufb01ned under the \u201cTerms for Comment\u201d. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 2 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Administra\u019fve Claims Data", "definition": "The informa\u019fon obtained from claims that health care providers submit to insurers to receive payment for treatments and other interven\u019fons. Claims data use standardized medical coding systems (nomenclatures), such as the World Health Organiza\u019fon Interna\u019fonal Classi\ufb01ca\u019fon of Diseases Coding (ICD-CM) to iden\u019ffy diagnoses, Na\u019fonal Drug Code (NDC) to iden\u019ffy drugs, and Current Procedural Terminology (CPT\u00ae) to iden\u019ffy procedures.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Causal Effect", "definition": "A measure of di\ufb00erence in outcome that would be expected in individuals subjected to an exposure of interest compared to the expected outcome if those same individuals were subjected to a speci\ufb01ed alterna\u019fve exposure (including no exposure). Source: Adapted from Musci R.J. & Stuart, E. (2019). Ensuring causal, not casual, inference. Prevention Science, 20, 452\u2013456, htps://doi.org/10.1007/s11121-018-0971-9.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Causal Inference", "definition": "The process of evalua\u019fon, es\u019fma\u019fon, and atribu\u019fon of a causal effect. Cluster Randomized Trial A trial in which randomiza\u019fon is at a group level (for instance, by community, health care facility or medical provider) rather than an individual level. Source: Adapted from the Secretary\u2019s Advisory Commitee on Human Research Protec\u019fons, Recommenda\u019fons on Regulatory Issues in Cluster Studies. (2014). Available at: Attachment C: Recommendations on Regulatory Issues in Cluster | HHS.gov.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Common Data Element", "definition": "A standardized, precisely defined variable or question that is paired with a set of specific allowable values or responses, that are used systematically across different sites, studies, or clinical trials to ensure consistent data collection and/or analysis. Source: Adapted from the NIH CDE Repository. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 3 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG Common Data Model (CDM) Comprehensive framework that includes de\ufb01ni\u019fons, speci\ufb01ca\u019fons, and opera\u019fonal rules for data to be presented and used in a common manner to enable interoperability. Source: Adapted from Duke Margolis Center for Health Policy, Characterizing RWD Quality and Relevancy for Regulatory Purposes. Available at htps://healthpolicy.duke.edu/sites/default/\ufb01les/2020- 03/characterizing_rwd.pdf. Completeness of Capture The extent to which a data source includes a complete representa\u019fon of the exposures, outcomes, and covariates needed for the proposed analysis. Incomplete capture may be due to variables that were not recorded or variables that include some missing values.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Computable Phenotype", "definition": "A clinical condi\u019fon or characteris\u019fc that can be ascertained using a computerized query to Electronic Health Record (EHR) system, administra\u019fve claims database, or clinical data repository using a de\ufb01ned set of data elements and logical expressions. Computable phenotype de\ufb01ni\u019fons provide the speci\ufb01ca\u019fons for iden\u019ffying popula\u019fons likely to have the condi\u019fons or characteris\u019fcs of interest. Source: Adapted from FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Confounding", "definition": "Systema\u019fc error in es\u019fma\u019fon of the measure of the e\ufb00ect of a medical product on an outcome due to another factor that is associated with both the exposure and the outcome and not through the causal pathway between exposure and outcome. Source: Adapted from Porta M. et al, A Dic\u019fonary of Epidemiology. (2014). United Kingdom: Oxford University Press. Con\u019fnuity of Coverage The period of \u019fme over which an individual is enrolled in a health care system (provider, pharmacy, insurer, or other) and for which data on provided or reimbursed healthcare services and treatments are captured in that system. Source: Adapted from FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 4 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data Cura\u019fon", "definition": "Processing of source data (unstructured and/or structured data) into a dataset suitable for analyses. The cura\u019fon process involves the applica\u019fon of standards for the exchange, integra\u019fon, sharing, and retrieval of source data, o\u014cen from various sources. For example, the applica\u019fon of standard medical diagnos\u019fc codes to adverse events, disease staging, the progression of disease, and other medical and clinical concepts. Source: Adapted from FDA \ufb01nal guidance CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support E\ufb00ectiveness of New Animal Drugs (October 2021). Data Harmoniza\u019fon The process of combining data from di\ufb00erent sources and reorganizing it according to a single schema so that data are compa\u019fble and comparable. Data are combined by either iden\u019ffying equivalent data elements between the sources or by applying speci\ufb01c transforma\u019fons between the elements to derive a common data element. Source: Adapted from the Na\u019fonal Ins\u019ftute of Environmental Health Sciences, Common Language Glossary from the Environmental Health Language Collabora\u019fve. Data Imputa\u019fon A process using sta\u019fs\u019fcal techniques to es\u019fmate missing data values, facilita\u019fng subsequent analyses. Source: Adapted from Food and Agricultural Organiza\u019fon of the United Na\u019fons, Sta\u019fs\u019fcal Standard Series Imputa\u019fon Version 2.0. Available at: htps://www.fao.org/3/cb9339en/cb9339en.pdf.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data Lake", "definition": "A controlled, centralized environment that stores structured and unstructured data in its na\u019fve form and provides infrastructure for organizing large volumes of diverse data from mul\u019fple sources. Source: Adapted from Amazon AWS. Data Transforma\u019fon The process of conver\u019fng data from one format or structure into another format or structure. It is a process of data extrac\u019fon and conversion or normaliza\u019fon in construc\u019fon of analy\u019fc datasets. Source: Adapted from FDA \ufb01nal guidance CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support E\ufb00ectiveness of New Animal Drugs (October 2021). Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 5 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data Warehouse", "definition": "A controlled, centralized environment that stores structured data in a processed form for analysis and provides infrastructure for data access by mul\u019fple applica\u019fons. Source: Adapted from FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics. Distributed Data Network A network in which data from mul\u019fple sites are transformed into a single common data model with the ability to execute a query without substan\u019fal modi\ufb01ca\u019fons on mul\u019fple datasets. Source: Adapted from FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Electronic Health Record", "definition": "An individual pa\u019fent record contained within an electronic system. A typical individual record may include a pa\u019fent medical history, diagnoses, treatment plans, immuniza\u019fons, allergies, imaging, pharmacy orders, laboratory values, and test results. Source: Adapted from FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Immortal Time", "definition": "A span of \u019fme in the observa\u019fon or follow-up period of a cohort during which the outcome under study could not have occurred, due to the cohort design and/or exposure de\ufb01ni\u019fon. Source: Adapted from Suissa, S. (2008). Immortal \u019fme bias in pharmacoepidemiology, American Journal of Epidemiology, 167(4),492\u2013499, htps://doi.org/10.1093/aje/kwm324. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 6 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG Informa\u019fon Bias Systema\u019fc error in es\u019fma\u019fon of an associa\u019fon or other parameter of interest arising from measurement error in the data. For categorical variables, measurement error is usually called classi\ufb01ca\u019fon error or misclassi\ufb01ca\u019fon. Source: Adapted from Daniel, G., Silcox, C., Bryan, J., McClellan, M., Romine, M., & Frank, K. (2018). Characterizing RWD Quality and Relevancy for Regulatory Purposes. Duke Margolis Center for Health Policy, htps://healthpolicy.duke.edu/sites/default/\ufb01les/2020- 03/characterizing_rwd.pdf and Rothman KJ, Greenland S, Lash TL, Lippincot Williams & Wilkins. (2008). Modern Epidemiology. Interven\u019fonal Study A study involving par\u019fcipants (e.g., healthy individuals or individuals with a disease or condi\u019fon of interest) whose exposure or interac\u019fon with a medical product is assigned according to a study protocol to evaluate the e\ufb00ect on health outcomes or product performance. Source: Adapted from FDA dra\u014c guidance Considera\u019fons for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (December 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Missing Data", "definition": "Data that would have been used in the study analysis but were not observed, collected, or accessible. This refers to informa\u019fon that is intended to be collected but is absent and informa\u019fon that is not intended to be collected and is therefore absent. There may be special considera\u019fons regarding real world data sources (e.g., electronic health records or claims); such data are generally not collected for primary research purposes and therefore may not have systema\u019fc data capture to answer a research ques\u019fon. Source: Adapted from FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "N of 1 Trial", "definition": "A clinical trial evalua\u019fng an interven\u019fon or mul\u019fple interven\u019fons in a single par\u019fcipant according to a protocol in which there is either switching between interven\u019fon(s) and control or a planned comparison between an interven\u019fon and a natural history. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 7 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG Non-interventional (observational) study A type of study in which individuals are not assigned to a medical product according to a protocol. Source: Adapted from FDA \ufb01nal guidance Use of Real-World Evidence to Support Regulatory Decision- Making for Medical Devices (August 2017) and FDA dra\u014c guidance Considera\u019fons for the Use of Real- World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (December 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Observa\u019fonal Study, Retrospec\u019fve", "definition": "A study that iden\u019f\ufb01es the popula\u019fon and determines the exposure/treatment from data collected before the ini\u019fa\u019fon of the study. The variables and outcomes of interest are determined at the \u019fme the study is designed. Source: Adapted from the Framework for FDA\u2019s Real-World Evidence Program (December 2018) and FDA \ufb01nal guidance Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (August 2017).", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Pragma\u019fc Clinical Trial", "definition": "A clinical trial designed to e\ufb03ciently inform decision-making on the bene\ufb01ts, burdens, and risks of health interven\u019fons in representa\u019fve popula\u019fons by including pragma\u019fc elements (see de\ufb01ni\u019fon below) that 1) are par\u019fally or fully integrated into rou\u019fne clinical prac\u019fce and/or 2) that streamline trial design and conduct. Source: Adapted from Cali\ufb00 R.M., Sugarman J. (2015). Exploring the ethical and regulatory issues in pragma\u019fc clinical trials. Clinical Trials, (5), 436-441, htps://journals.sagepub.com/doi/10.1177/1740774515598334. Pragma\u019fc Elements Design features that can be integrated into a clinical trial, including but not limited to, one or more of the following elements: broad eligibility criteria, simpli\ufb01ed recruitment and follow-up, \ufb02exibility in delivery of the interven\u019fon (e.g., community se\u01abngs), \ufb02exibility in assessment frequency, and measurement of outcomes relevant to the popula\u019fon. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 8 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Propensity Score", "definition": "The condi\u019fonal probability of assignment to a par\u019fcular treatment given a set (e.g., vector) of observed covariates. Source: Adapted from Rosenbaum, P.R., Rubin, D.B. (1983). The central role of the propensity score in observa\u019fonal studies for causal e\ufb00ects, Biometrika, 70(1), 41\u201355, htps://doi.org/10.1093/biomet/70.1.41.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Registry", "definition": "An organized system that collects clinical and other data in a standardized format for a popula\u019fon de\ufb01ned by a par\u019fcular disease, condi\u019fon, or exposure. Source: Adapted from FDA \ufb01nal guidance Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products (December 2023) and FDA \ufb01nal guidance Use of Real- World Evidence to Support Regulatory Decision-Making for Medical Devices (August 2017).", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Residual Confounding", "definition": "Confounding (see definition) that remains a\u014cer adjus\u019fng for measured confounders. Source: Adapted from Porta, M. A dic\u019fonary of epidemiology (6th ed.), https://www.oxfordreference.com/display/10.1093/acref/9780199976720.001.0001/acref- 9780199976720-e-1649.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Selec\u019fon Bias", "definition": "Systema\u019fc error in es\u019fma\u019fon of an associa\u019fon or other parameter that occurs from factors that in\ufb02uence study par\u019fcipa\u019fon [or eligibility]. Source: Adapted from Rothman KJ, Greenland S, Lash TL, Lippincot Williams & Wilkins. (2008). Modern Epidemiology. Sequen\u019fal, Mul\u019fple Assignment, Randomized Trial (SMART) A trial designed to evaluate a collec\u019fon of interven\u019fons guided by a sequence of decision rules that speci\ufb01es when and how the type and/or intensity of an interven\u019fon should be modi\ufb01ed depending on the pa\u019fent\u2019s past or present characteris\u019fcs and/or ongoing clinical state or performance (e.g., response, adherence) to op\u019fmize clinically important outcomes. In such a trial, pa\u019fents move along mul\u019fple stages and are randomly assigned to one of several suitable interven\u019fon op\u019fons at each stage. Source: Adapted from FDA \ufb01nal guidance Interac\u019fng with the FDA on Complex Innova\u019fve Trial Designs for Drugs and Biological Products (December 2020). Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 9 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG Stepped Wedge Cluster Randomized Trial In a stepped wedge group-randomized trial, also called a stepped wedge cluster randomized trial, groups or clusters are randomized to sequences that direct them to switch from a control to the interven\u019fon at predetermined \u019fme points in a sequen\u019fal, staggered fashion un\u019fl all clusters receive the interven\u019fon. Source: Adapted from Home | Research Methods Resources (nih.gov). Synthe\u019fc Data Data that have been created ar\u019f\ufb01cially (e.g., through sta\u019fs\u019fcal modeling, computer simula\u019fon) so that new values and/or data elements are generated. Generally, synthe\u019fc data are intended to represent the structure, proper\u019fes and rela\u019fonships seen in actual pa\u019fent data, except that they do not contain any real or speci\ufb01c informa\u019fon about individuals.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Target Trial Emula\u019fon", "definition": "A framework for designing and analyzing an observa\u019fonal study based on conceptualizing a target randomized trial to answer a scien\u019f\ufb01c ques\u019fon and designing the observa\u019fonal study to mimic the trial es\u019fmand(s) (including speci\ufb01ca\u019fon of popula\u019fon eligibility criteria, treatment strategies and assignment procedures, outcomes, handling of intercurrent events, and follow-up period).", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Time-Related Bias", "definition": "Systema\u019fc error in es\u019fma\u019fon of an associa\u019fon or other parameter of interest due to misclassi\ufb01ca\u019fon or exclusion of person-\u019fme atributed to the treatment, interven\u019fon, or exposure. Examples include protopathic bias, latency \u019fme bias, immortal \u019fme bias, \u019fme-window bias, deple\u019fon-of-suscep\u019fbles, immeasurable \u019fme bias, and other such biases.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Umbrella Trial", "definition": "Trial designed to evaluate mul\u019fple medical products in separate sub-studies concurrently for a single disease or condi\u019fon. Source: Adapted from FDA dra\u014c guidance Master Protocols for Drug and Biological Product Development | FDA (December 2023). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 10 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Terms for Reference \u2013 These terms are included because they provide context for terms under \u201cTerms for", "definition": "Comment\u201d. We are not reques\u019fng comment on these terms. Adap\u019fve Design A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. Source: FDA \ufb01nal guidance Adap\u019fve Design Clinical Trials for Drugs and Biologics Guidance for Industry (December 2019).", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Basket Trial", "definition": "Trial designed to evaluate a medical product for di\ufb00erent diseases, condi\u019fons, or disease subtypes. Source: FDA dra\u014c guidance Master Protocols for Drug and Biological Product Development | FDA (December 2023). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics. Conceptual De\ufb01ni\u019fon Explains a study construct (e.g., exposure, outcomes, covariates) or feature in general or qualita\u019fve terms. Source: FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Master Protocol", "definition": "A protocol designed with mul\u019fple sub-studies, which may have di\ufb00erent objec\u019fves and involve coordinated e\ufb00orts to evaluate one or more medical products in one or more diseases or condi\u019fons within the overall study structure. Source: FDA dra\u014c guidance Master Protocols for Drug and Biological Product Development | FDA (December 2023). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics. Glossary Terms and De\ufb01ni\u019fons", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 11 of 11", "definition": "Dra\u014c Product of FDA-NIH CRWG Observa\u019fonal Study, Prospec\u019fve A study in which the popula\u019fon of interest is iden\u019f\ufb01ed at the start of the study, and exposure/treatment and outcome data are collected from that point forward. The start of the study is de\ufb01ned as the \u019fme the research protocol for the speci\ufb01c study ques\u019fon was ini\u019fated. Source: Framework for FDA\u2019s Real-World Evidence Program (December 2018). Opera\u019fonal De\ufb01ni\u019fon The data-speci\ufb01c opera\u019fon or procedure a researcher followed to measure constructs in a par\u019fcular study. Source: FDA dra\u014c guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September 2021). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics. Pa\u019fent Generated Health Data Health-related data created, recorded, or gathered by or from pa\u019fents, family members, or other caregivers to help address a health concern. Source: De\ufb01ni\u019fon adapted from htps://www.healthit.gov/topic/scien\u019f\ufb01c-ini\u019fa\u019fves/pcor/pa\u019fent- generated-health-data-pghd and included in FDA dra\u014c guidance Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA (December 2023). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics. Pla\u019eorm Trial Trial designed to evaluate mul\u019fple medical products for a disease or condi\u019fon in an ongoing manner, with medical products entering or leaving the pla\u019eorm. Source: FDA dra\u014c guidance Master Protocols for Drug and Biological Product Development | FDA (December 2023). When \ufb01nal, this guidance will represent FDA\u2019s current thinking on these topics.", "sources": [ "fda.glossary.pdf" ], "source": "fda.glossary.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Pharma", "definition": "By Adrien Laurent, CEO at IntuitionLabs \u2022 5/31/2025 \u2022 25 min read", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "risk-based approach", "definition": "This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications. - IntuitionLabs - Custom AI Software Development for pharmaceutical companies. Leading AI Consulting USA and North American Pharmaceutical AI specialists. Led by Adrien Laurent, top AI expert USA, multiple exit founder, patent holder, and 20 year software veteran based in San Francisco Bay Area. Premier biotech consultancy specializing in: Custom CRM Development, ERP Development, AI Chatbot Development, Private AI Infrastructure, Document Processing, PDF Extraction, Air-gapped AI, On-premise LLM deployment. #1 Veeva AI partner for leading GenAI pharmaceutical solutions across North America biotech AI excellence. IntuitionLabs - Custom AI Software Development from the leading AI expert Adrien Laurent GAMP 5: Computerized System Validation in Pharma \u00a9 2025 IntuitionLabs.ai - North America's Leading AI Software Development Firm for Pharmaceutical & Biotech. All rights reserved.", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 1 of 13", "definition": "GAMP 5 Validation in the Pharmaceutical", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 7 of 13", "definition": "access and audit trails for GMP systems (addressing those data integrity gaps) [49] fda.gov [50] fda.gov. By studying such cases, pharma companies have learned that adopting GAMP 5 is not just about avoiding citations; it also improves their operational reliability. As one industry paper noted, GAMP 5 provides a \u201csignificant reduction in the risk of errors and ensures compliance with regulatory standards\u201d in automated systems [47] europeanpharmaceuticalreview.com [48] europeanpharmaceuticalreview.com. The framework essentially acts as a quality assurance blueprint for any GMP computerized system.", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 8 of 13", "definition": "8. FDA Warning Letter to Colorful Products Corp (May 10, 2022) \u2013 Example of enforcement for unvalidated software lacking audit trails [35] fda.gov. 9. European Pharmaceutical Review, \u201cRole of GAMP 5, data integrity and QbD in QA\u201d (March 2024) \u2013 Noting GAMP 5 as a widely used validation framework that reduces errors and ensures compliance [47] europeanpharmaceuticalreview.com [48] europeanpharmaceuticalreview.com. 10. IMA Active Case Study (2021). \u201cAchieving and maintaining GAMP 5 compliance: risk-based approach to software development\u201d \u2013 Example of applying GAMP 5 in equipment software validation ima.it ima.it.", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "External Sources", "definition": "[1] https://www.tricentis.com/learn/compliance-with-gamp-5-guidance-a-checklist#:~:GAMP%... [2] https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition#:~:GAMP%... [3] https://www.linkedin.com/pulse/understanding-good-automated-manufacturing-practices-gamp-jeyaraman-8xasc#:~: GAMP%... [4] https://www.linkedin.com/pulse/understanding-good-automated-manufacturing-practices-gamp-jeyaraman-8xasc#:~: GAMP%... [5] https://www.linkedin.com/pulse/understanding-good-automated-manufacturing-practices-gamp-jeyaraman-8xasc#:~: 1,val... [6] https://www.linkedin.com/pulse/understanding-good-automated-manufacturing-practices-gamp-jeyaraman-8xasc#:~: compu... [7] https://www.linkedin.com/pulse/understanding-good-automated-manufacturing-practices-gamp-jeyaraman-8xasc#:~: 2,bas... [8] https://www.linkedin.com/pulse/understanding-good-automated-manufacturing-practices-gamp-jeyaraman-8xasc#:~: 3,inc... [9] https://www.linkedin.com/pulse/understanding-good-automated-manufacturing-practices-gamp-jeyaraman-8xasc#:~: defin... [10] https://ispe.org/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd- edition#:~:ISPE%... [11] https://ispe.org/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd- edition#:~:Guida... [12] https://ispe.com/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd -edition#:~:GAMP%... [13] https://ispe.org/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd- edition#:~:Since... [14] https://ispe.org/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd- edition#:~:One%2... [15] https://www.tricentis.com/learn/compliance-with-gamp-5-guidance-a-checklist#:~:GAMP%... [16] https://www.scilife.io/blog/gamp5-for-gxp-compliant-computerized-systems#:~:The%2... IntuitionLabs - Custom AI Software Development from the leading AI expert Adrien Laurent GAMP 5: Computerized System Validation in Pharma \u00a9 2025 IntuitionLabs.ai - North America's Leading AI Software Development Firm for Pharmaceutical & Biotech. All rights reserved.", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 10 of 13", "definition": "[48] https://www.europeanpharmaceuticalreview.com/news/218579/the-role-of-gamp-5-data-integrity-and-qbd-in-pharma ceutical-quality-assurance/#:~:5%20b... [49] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colorful-produc ts-corporation-624415-05102022#:~:In%20... [50] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colorful-produc ts-corporation-624415-05102022#:~:indiv... [51] https://ispe.org/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd- edition#:~:GAMP%... [52] https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition#:~:Maint... IntuitionLabs - Custom AI Software Development from the leading AI expert Adrien Laurent GAMP 5: Computerized System Validation in Pharma \u00a9 2025 IntuitionLabs.ai - North America's Leading AI Software Development Firm for Pharmaceutical & Biotech. All rights reserved.", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Page 11 of 13", "definition": "IntuitionLabs - Industry Leadership & Services North America's #1 AI Software Development Firm for Pharmaceutical & Biotech: IntuitionLabs leads the US market in custom AI software development and pharma implementations with proven results across public biotech and pharmaceutical companies. Elite Client Portfolio: Trusted by NASDAQ-listed pharmaceutical companies including Scilex Holding Company (SCLX) and leading CROs across North America. Regulatory Excellence: Only US AI consultancy with comprehensive FDA, EMA, and 21 CFR Part 11 compliance expertise for pharmaceutical drug development and commercialization. Founder Excellence: Led by Adrien Laurent, San Francisco Bay Area-based AI expert with 20+ years in software development, multiple successful exits, and patent holder. Recognized as one of the top AI experts in the USA. Custom AI Software Development: Build tailored pharmaceutical AI applications, custom CRMs, chatbots, and ERP systems with advanced analytics and regulatory compliance capabilities. Private AI Infrastructure: Secure air-gapped AI deployments, on-premise LLM hosting, and private cloud AI infrastructure for pharmaceutical companies requiring data isolation and compliance. Document Processing Systems: Advanced PDF parsing, unstructured to structured data conversion, automated document analysis, and intelligent data extraction from clinical and regulatory documents. Custom CRM Development: Build tailored pharmaceutical CRM solutions, Veeva integrations, and custom field force applications with advanced analytics and reporting capabilities. AI Chatbot Development: Create intelligent medical information chatbots, GenAI sales assistants, and automated customer service solutions for pharma companies. Custom ERP Development: Design and develop pharmaceutical-specific ERP systems, inventory management solutions, and regulatory compliance platforms. Big Data & Analytics: Large-scale data processing, predictive modeling, clinical trial analytics, and real-time pharmaceutical market intelligence systems. Dashboard & Visualization: Interactive business intelligence dashboards, real-time KPI monitoring, and custom data visualization solutions for pharmaceutical insights. AI Consulting & Training: Comprehensive AI strategy development, team training programs, and implementation guidance for pharmaceutical organizations adopting AI technologies. Contact founder Adrien Laurent and team at https://intuitionlabs.ai/contact for a consultation. IntuitionLabs - Custom AI Software Development from the leading AI expert Adrien Laurent GAMP 5: Computerized System Validation in Pharma \u00a9 2025 IntuitionLabs.ai - North America's Leading AI Software Development Firm for Pharmaceutical & Biotech. All rights reserved.", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DISCLAIMER", "definition": "The information contained in this document is provided for educational and informational purposes only. We make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability of the information contained herein. Any reliance you place on such information is strictly at your own risk. 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IntuitionLabs - Custom AI Software Development from the leading AI expert Adrien Laurent GAMP 5: Computerized System Validation in Pharma \u00a9 2025 IntuitionLabs.ai - North America's Leading AI Software Development Firm for Pharmaceutical & Biotech. All rights reserved.", "sources": [ "gamp-5-computerized-system-validation-in-pharma.pdf" ], "source": "gamp-5-computerized-system-validation-in-pharma.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Official address Domenico Scarlattilaan 6 \u25cf 1083 HS Amsterdam \u25cf The Netherlands", "definition": "An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 \u00a9 European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged. 9 March 2023 EMA/INS/GCP/112288/2023 Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "clinical trials", "definition": "Adopted by GCP IWG for release for consultation 4 March 2021 Start of public consultation 18 June 2021 End of consultation (deadline for comments) 17 December 2021 Final version adopted by the GCP IWG 7 March 2023 Date of coming into effect 6 months after publication This guideline replaces the 'Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials' (EMA/INS/GCP/454280/2010).", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Keywords", "definition": "Computerised systems, electronic data, validation, audit trail, user management, security, electronic clinical outcome assessment (eCOA), interactive response technology (IRT), case report form (CRF), electronic signatures, artificial intelligence (AI) Guideline on computerised systems and electronic data in clinical trials EMA/INS/GCP/112288/2023 Page 2/52 Guideline on computerised systems and electronic data in", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Generally used terms", "definition": "Unless otherwise specified (e.g. 'source data' or 'source document') and in order to simplify the text, 'data' will be used in this guideline in a broad meaning, which may include documents, records or any form of information. All references to sponsors and investigators in this guideline also apply to their service providers, irrespective of the services provided. When a computerised system is implemented by an institution where the investigator is conducting a clinical trial, any reference to the investigator in this guideline also includes the institution, when applicable. The term 'trial participant' is used in this text as a synonym for the term 'subject', which is defined in Regulation (EU) No 536/2014 as 'an individual who participates in a clinical trial, either as a recipient of the IMP or as a control'. The term 'responsible party' is frequently used instead of sponsor or principal investigator. Please also refer to section 4.2. and Annex 1. The term 'agreement' is used as an overarching term for all types of documented agreements, including contracts. The term 'validation' encompasses aspects usually known as 'qualification and validation'. Artificial intelligence Artificial intelligence (AI) covers a very broad set of algorithms, which enable computers to mimic human intelligence. It ranges from simple if-then rules and decision trees to machine learning and deep learning.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Audit trail", "definition": "In computerised systems, an audit trail is a secure, computer generated, time-stamped electronic record that allows reconstruction of the events relating to the creation, modification, or deletion of an electronic record. Clinical outcome assessment Clinical outcome assessment (COA) employs a tool for the reporting of outcomes by clinicians, trial site staff, observers, trial participants and their caregivers. The term COA is proposed as an umbrella term to cover measurements of signs and symptoms, events, endpoints, health-related quality of life (HRQL), health status, adherence to treatment, satisfaction with treatment, etc. Computerised system life cycle The life cycle of a computerised system includes all phases of the system; i.e. typically 1) the concept phase where the responsible party considers to automate a process and where user requirements are collected, 2) the project phase where a service provider can be selected, a risk-assessment is made, and the system is implemented and validated, 3) the operational phase where a system is used in a regulated environment and changes are implemented in a manner that maintains data confidentiality, integrity and availability, and finally, 4) a retirement phase, which includes decisions about data retention/archiving, migration or destruction and the management of these processes.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Configuration", "definition": "Configuration sets up a system using existing (out-of-the-box) functionality. It requires no programming knowledge. Guideline on computerised systems and electronic data in clinical trials EMA/INS/GCP/112288/2023 Page 6/52", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Customisation", "definition": "Customisation modifies and adds to existing functionality by custom coding. It requires programming knowledge.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data governance", "definition": "The total of activities, processes, roles, policies, and standards used to manage and control the data during the entire data life cycle, while adhering to ALCOA++ principles (see section 4.5.).", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Data life cycle", "definition": "All processes related to the creating, recording, processing, reviewing, changing, analysing, reporting, transferring, storing, migrating, archiving, retrieving, and deleting of data.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Dynamic file formats", "definition": "Dynamic files include automatic processing and/or enable an interactive relationship with the user. A certified electronic copy may be retained in electronic file formats that are different from the original record, but the equivalent dynamic nature (including metadata) of the original record should be retained.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Event log", "definition": "An automated log of events in relation to the use of a system like system access, alerts or firing of edit checks. Patient-reported outcome Any outcome reported directly by the trial participant and based on the trial participant's perception of a disease and its treatment(s) is called patient-reported outcome (PRO). The term PRO is proposed as an umbrella term to cover both single dimension and multi-dimension measurements of symptoms, HRQL, health status, adherence to treatment, satisfaction with treatment, etc. (Source: CHMP 'Reflection paper on the regulatory guidance for the use of HRQL measures in the evaluation of medicinal products' - EMEA/CHMP/EWP/139391/2004)", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Static file formats", "definition": "Static files containing information or data that are fixed and allow no dynamic interaction.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Validation", "definition": "'A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of clinical trial results.' (ICH E6 R2 1.65) Guideline on computerised systems and electronic data in clinical trials EMA/INS/GCP/112288/2023 Page 7/52", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "AI", "definition": "artificial intelligence ALCOA++ attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available when needed and traceable", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "DSMB", "definition": "data and safety monitoring board", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "PRO", "definition": "patient-reported outcome Guideline on computerised systems and electronic data in clinical trials EMA/INS/GCP/112288/2023 Page 8/52", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "SUSAR", "definition": "suspected unexpected serious adverse reactions", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Electronic trial participant data capture devices used to collect ePRO data, e.g. mobile", "definition": "devices supplied to trial participants or applications for use by the trial participant on their own device i.e. bring your own device (BYOD).", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Figure 1", "definition": "Data capture sometimes requires some degree of processing prior to data recording. In this process, the data generated during an observation, measurement or data collection is checked, processed, and transferred into a new format and then recorded. The retention of unprocessed data records is not always feasible. If the processing is an integral part of the solution used and is recognisable as such in the solution characteristics, there is no need to extract and retain the unprocessed data. It should be possible to validate the correct operation of the processing. As a general principle, the source data should be processed as little as possible and as much as necessary. From a practical point of view, the first obtainable permanent data from an electronic data generation/capture should be considered and defined as the electronic source data. This process should be validated to ensure that the source data generated/captured is representative of the original observation and should contain metadata, including audit trail, to ensure adherence to the ALCOA++ principles (see section 4.5.). The location where the source data is first obtained should be part of the metadata. 4.5. ALCOA++ principles A number of attributes are considered of universal importance to data. These include that the data are:", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Attributable", "definition": "Data should be attributable to the person and/or system generating the data. Based on the criticality of the data, it should also be traceable to the system/device, in which the data were generated/captured. The information about originator (e.g. system operator, data originator) and system (e.g. device, process) should be kept as part of the metadata.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Legible", "definition": "Data should be maintained in a readable form to allow review in its original context. Therefore, changes to data, such as compression, encryption and coding should be completely reversible. Guideline on computerised systems and electronic data in clinical trials EMA/INS/GCP/112288/2023 Page 13/52", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Contemporaneous", "definition": "Data should be generated by a system or captured by a person at the time of the observation. The time point of the observation and the time point of the storage should be kept as part of the metadata, including the audit trail. Accurate date and time information should be automatically captured and should be linked and set by an external standard.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Original", "definition": "Data should be the original first generation/capture of the observation. Certified copies can replace original data (see section 6.5. on certified copies). Information that is originally captured in a dynamic state should remain available in that state.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Accurate", "definition": "The use of computerised systems should ensure that the data are at least as accurate as those recorded on paper. The coding process, which consists in matching text or data collected on the data acquisition tools to terms in a standard dictionary, thesaurus, or tables (e.g. units, scales), should be controlled. The process of data transfer between systems should be validated to ensure the data remain accurate. Data should be an accurate representation of the observations made. Metadata should contain information to describe the observations and, where appropriate, it could also contain information to confirm its accuracy.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Complete", "definition": "To reconstruct and fully understand an event, data should be a complete representation of the observation made. This includes the associated metadata and audit trail and may require preserving the original context.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Consistent", "definition": "Processes should be in place to ensure consistency of the definition, generation/capturing and management (including migration) of data throughout the data life cycle. Processes should be implemented to detect and/or avoid contradictions, e.g. by the use of standardisation, data validation and appropriate training.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Enduring", "definition": "Data should be maintained appropriately such that they remain intact and durable through the entire data life cycle, as appropriate, according to regulatory retention requirements (see sections 6.8. and 6.10. on back-up and archiving).", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Available when needed", "definition": "Data should be stored throughout the data life cycle and should be readily available for review when needed.", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Traceable", "definition": "Data should be traceable throughout the data life cycle. Any changes to the data, to the context/metadata should be traceable, should not obscure the original information and should be explained, if necessary. Changes should be documented as part of the metadata (e.g. audit trail). 4.6. Criticality and risks ICH E6 describes the need for a quality management system with a risk-based approach. Risks should be considered at both the system level e.g. standard operating procedures (SOPs), computerised systems and staff, and for the specific clinical trial e.g. trial specific data and data acquisition tools or trial specific configurations or customisations of systems. Guideline on computerised systems and electronic data in clinical trials EMA/INS/GCP/112288/2023 Page 14/52 Risks in relation to the use of computerised systems and especially critical risks affecting the rights, safety and well-being of the trial participants or the reliability of the trial results would be those related to the assurance of data integrity. Those risks should be identified, analysed, and mitigated or accepted, where justified, throughout the life cycle of the system. Where applicable, mitigating actions include revised system design, configuration or customisation, increased system validation or revised SOPs (including appropriate training) for the use of systems and data governance culture. In general, risks should be determined based on the system used, its complexity, operator, use of system and data involved. Critical component parts of any system should always be addressed. For example, a component part of an IRT system that calculates IMP dose based on data input by the investigator would be high risk compared to other functionalities such as the generation of an IMP shipment report. The interface and interdependency between systems or system components should be taken into consideration. All data collected or generated in the context of a clinical trial should fulfil ALCOA++ principles. Consequently, the arrangements for data governance to ensure that data, irrespective of the format in", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "Figure 2", "definition": "Guideline on computerised systems and electronic data in clinical trials EMA/INS/GCP/112288/2023 Page 27/52", "sources": [ "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf" ], "source": "guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "type": "pdf", "file": "glossary.json" }, { "term": "additive effect", "definition": "Glossary Definition: The combined effect when two or more things are used together.Use in Context: The additive effect of a combination drug is the sum of the effects of each drug acting alone.More Info: For example, two vaccines may be combined into one shot because they do not interfere with each other and will still each have the same effect as if they were given as two separate shots. So an additive effect means that 1+1 = 2Other Info to Think About When Joining a Study: You may hear the words \u201cadditive effect\u201d being used if you are part of a study that is studying two or more treatments being taken together. You may want to find out more about why the two treatments are being given together and what the hoped effect could be.Related Terms: synergistic effect", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adherence", "definition": "Glossary Definition: Following the study directions and requirements.Use in Context: Adherence to the study instructions is important so reliable information about the study treatment can be collected.More Info: Adherence to the study protocol helps ensure the data from all study participants can be evaluated appropriately. Reliable research results depend on both researchers and participants carefully following the protocol and study instructions. The words 'adherence' and 'compliance' are often used in the same way.Other Info to Think About When Joining a Study: During study visits, someone from the study team may ask about your adherence to the study directions. That could mean following the exact directions for taking the investigational medicine or writing journal entries at specific time points. When you are reading through the consent form you may see that it says you could be removed from the study by the investigator if you are unable to follow the study procedures. You may wish to ask what you should do if you were unable to follow the study directions on a particular day. For example, if you forgot to take the study treatment at the right time. If you have a hard time following the study procedures, let the study team know so they can help you.Related Terms: compliance, following", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adverse event", "definition": "Glossary Definition: Any health problem that happens during the study.Use in Context: The study team needs to know about all adverse events that happen during the study.More Info: Researchers track adverse events for safety reasons. They also want to find out whether any issues could be related to the study treatment. Participants should tell the study team about any health problem that happens while they are in a study. Any event such as a fever, headache, cold, a mood change, or falling, should be reported.Other Info to Think About When Joining a Study: You may see references to \u201cadverse event\u201d during the consent process when discussing procedures since many studies include specific time points to ask participants if they have experienced any health problems. You may also see references to \u201cadverse event\u201d when discussing the risks of the study. Depending on the type of study you join, the risks you learn about are based on information participants in previous studies reported. It is important that you tell the study team about any health problem that happens during the study, even if you don\u2019t think it\u2019s related to the research.Related Terms: adverse reaction, side effect", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adverse reaction", "definition": "Glossary Definition: A health problem that happens during the study and is reported as possibly caused by the study treatment.Use in Context: Adverse reactions are important to track so that the effects of the study treatment are known.More Info: Adverse reactions are health problems that are related to the study treatment. A rash that develops only after taking a drug is an adverse reaction.Other Info to Think About When Joining a Study: While participating in a study, the study team may discuss adverse reactions with you. Adverse reactions are health issues that have been found to be related to the study treatment. It is important for you to report any health problem or issue that happens while you are in a study, even if you don\u2019t think it\u2019s related.Related Terms: adverse event, side effect", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "analyze", "definition": "Glossary Definition: To examine study data to answer a question and help reach conclusions.Use in Context: Researchers analyze data to find out the results of a study.More Info: In a research study, data are collected and then analyzed to answer the study questions. A study statistician helps analyze the data. When they analyze the data, they interpret the information and try to come to conclusions about what the study results mean.Other Info to Think About When Joining a Study: You may often hear the term \u201canalyze\u201d used by the study team in the context of data. Someone on the research team will need to analyze the data collected in the research study. You may want to ask how the data will be analyzed and what the researchers want to learn from the study.Related Terms: evaluate, investigate, interpret, data analysis", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "anonymize", "definition": "Glossary Definition: Remove, change, or hide personal details to protect participant privacy.Use in Context: When researchers anonymize data they remove all personal identifiers, so that the participant cannot be linked back to that data by anyone.More Info: When data are anonymized, details such as name, birthdate, and address are removed so that any personal information is no longer available to anyone.Other Info to Think About When Joining a Study: You may hear the term \u201canonymize\u201d when the study team talks about the data they collect from you during the study and how that data will be protected. There are different ways to protect data. When data are anonymized, they cannot be linked back to any individual. As a participant, you can ask the study team for more information about what data they will collect and how they will protect your personal information. You may also want to clarify if the information they collect from you will be anonymized.Related Terms: unlink, mask", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "antibody", "definition": "Glossary Definition: A protein made by the body to fight an illness or infection.Use in Context: Antibodies develop after an infection to help clear the infection and to prevent the infection from coming back.More Info: An antibody is a protein that is produced by the body's immune system and causes an immune response. Antibodies can be found in various areas of the body, including the blood, skin, lungs, tears, saliva, and even breast milk. Antibodies can be produced in response to viruses, bacteria, parasites and even medications. Antibodies can sometimes recognize someone\u2019s own body tissues and cause disease. In some cases, antibodies can also be used as a treatment/therapy. For example, antibodies are sometimes used to fight cancer cells.Other Info to Think About When Joining a Study: A research study may test whether a study treatment causes a person to develop antibodies to a disease. It may also test an antibody to see if it can treat a disease. If you have any questions about antibodies or immune reactions, you can ask the study team.Related Terms: immune system, immunoglobulin, protein, antigen, immunotherapy", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "antigen", "definition": "Glossary Definition: A substance that causes the body's immune system to react.Use in Context: An antigen is something that your body does not recognize and tries to fight.More Info: The body reacts to an antigen like a virus, bacteria, parasite, or tumor. Immune reactions include getting a fever, a rash or hives, or feeling sick. One of the ways that the immune system protects itself from antigens is to produce antibodies.Other Info to Think About When Joining a Study: You may see the term \u201cantigen\u201d in different research study situations. For example you may see it in the title of a research study, in the consent form, or in other study information. During the Covid pandemic, there was a lot of information about antigen tests. Feel free to ask a member of the study team for more information if you have questions about the term \u201cantigen\u201d being used in a research study.Related Terms: antibody, immune response", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "arm", "definition": "Glossary Definition: A group of participants in a research study who all receive the same study treatment.Use in Context: If a study has two arms, one group will receive one study treatment while a second group will receive a different study treatment such as a placebo or the standard of care.More Info: Studies that compare two or more study treatments divide participants into separate arms to compare the effects of the different treatments.Other Info to Think About When Joining a Study: You may see the term \u201carm\u201d in the consent form or when the study team is explaining the research study to you. They may mention that there will be different arms in the study you are joining. You may be randomized to one arm or another You can ask how many arms will be in a study. If there are arms, you can clarify how participants will be assigned to receive the different study treatments.Related Terms: study arm, group, study assignment, randomization, cohort, treatment group", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "assent", "definition": "Glossary Definition: Willingness to take part in a research study by someone who is not able to give legal consent.Use in Context: Some studies ask children, or people who have a guardian, to decide whether they agree to participate in research by giving their assent.More Info: Assent can apply both to children and to adults who can't give legal informed consent. For example, an adult with severe dementia may no longer be able give consent but could be asked to assent Confirming the assent of children and adults who are unable to give legal consent treats them with respect, even if not legally necessary. Failing to object to being in a study is not considered assent. Assent can apply to children and adults who can't give legal informed consent. For example, in the case of an adult with dementia. To leave a study, a participant may take back their assent, or the legal guardian or authorized decision maker may take back their consent.Other Info to Think About When Joining a Study: The word \u201cassent\u201d may come up if minors are joining a study. When applicable, the parent or guardian may be signing to give consent, but the young person should be given the opportunity to assent to become a participant. The study team may also say that even if the guardian provides consent, the young person joining the study will need to give their assent before enrolling. A minor who is enrolling in a study should feel free to ask as many questions about the research as necessary to feel comfortable becoming a participant.Related Terms: agreement, consent", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "assent form", "definition": "Glossary Definition: A document used to explain the details of a research study to children or people who are unable to give legal consent.Use in Context: An assent form provides information about the research in a way that is easy to understand.More Info: An assent form provides research study information in a way that children and others who may have impaired decision-making can understand. Giving children and people with impaired decision-making an assent form that is designed for them helps them to understand the research and decide how they feel about the study.Other Info to Think About When Joining a Study: If you are the parent or guardian of a child, you will be deciding about the study and signing the consent form. You can ask the study team if there is an assent form for the child to understand the study. A similar process can be followed if a study is enrolling adults who are not able to make decisions on their own about being in a research study. You can use the assent form to guide a conversation to make sure the potential participant agrees with being in the research study.Related Terms: assent, minor, guardian, consent, consent form", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "assessment", "definition": "Glossary Definition: Information that is collected and analyzed from a study participant.Use in Context: A study often includes assessments, like surveys or medical tests.More Info: An assessment is used in research to collect data that helps the researchers answer the study questions.Other Info to Think About When Joining a Study: You may hear the word \"assessment\" when the study team tells you about the study procedures that will be done during the study. An assessment could be a questionnaire you do on your own or a procedure that is done by someone on the study team (like getting a blood pressure reading). Ask if you are not sure what the study assessment is for and what data are being collected. If the assessment involves any medical tests, you could ask if you need to do anything special to prepare.Related Terms: test, questionnaire, survey, baseline assessment", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "baseline assessment", "definition": "Glossary Definition: Information that is collected and analyzed from a study participant at the start of a study.Use in Context: A baseline assessment collects data about the participant\u2019s health status at the start of a study before any study treatment is given.More Info: A baseline assessment is used to compare how the participant's health status changes during the study. For example, if a study is measuring weight loss, the participant\u2019s weight must be taken at the start of the study to see if the participant loses weight while they are in the study. A baseline assessment could include questionnaires, lab tests, or other medical information for the study.Other Info to Think About When Joining a Study: You may hear thie term \"baseline assessment\" when the study team tells you about what you need to do for the research study. They may ask you to complete a \"baseline assessment\" to collect information at the start of the study. Some baseline assessments are done by the participant (like a survey) while others might be done with a person from the study team (like a blood draw). If you do not understand the baseline assessment at the start of the study, please ask the study team to clarify.Related Terms: assessment, questionnaire, survey", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "basket trial", "definition": "Glossary Definition: A research study that tests one study treatment for different diseases and conditions.Use in Context: A basket trial is done to see whether a study treatment can work for multiple different conditions that have something in common.More Info: A basket trial is a type of platform or master protocol study. A basket trial is done to find out whether one drug can treat multiple diseases. A basket trial enrolls patients with different diseases that have something in common.Other Info to Think About When Joining a Study: You may hear about basket trials when you are learning about different types of study designs. If you are thinking of joining a \"basket trial\" it means the study will be trying to find out if one treatment could help with a few different diseases or conditions. If you are unclear what it means for a research study to be a basket trial, you should ask a member of the study team to clarify any of your questions.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "benefits of a research study", "definition": "Glossary Definition: The ways a research study might help the participant and others.Use in Context: Learning about the possible benefits of a research study can help someone decide whether or not to enroll.More Info: Research studies may have benefits for individuals and/or society. For example, a personal benefit of being in a research study might be regular health checks. A benefit to society may be helping future patients or the public, even if an individual participant does not directly benefit. Participants may not have any benefits from being in a research study.Other Info to Think About When Joining a Study: The consent form will include information about whether or not there will be direct benefits to you if you participate in a research study. You should ask about more details of the benefits of the research, if there are any. You can also ask about the risks of participating in the study.Related Terms: benefits of a clinical trial, benefits, advantages, pros", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "bias (research)", "definition": "Glossary Definition: Flaws in the way a study is designed, done, or analyzed that lead to one conclusion being favored over another.Use in Context: Research bias can affect the results and outcomes of the research.More Info: Bias in research can occur either on purpose or accidentally. Bias may cause false conclusions or misleading results. All research study staff should be aware of, and reduce, potential sources of bias. Research bias can occur when a study is being planned, conducted, or analyzed. Bias can happen based on data selection, study methods, individual experiences, or personal opinions. Statistical or personal factors and can cause results or findings to lean one way over another. For example, if a researcher only recruits participants who speak English, people who speak another language would not be represented.Other Info to Think About When Joining a Study: The concept of \"research bias\" may come up when reading results and trying to interpret the way the study was conducted. When you think about a study's results, you may have questions about whether there was any potential bias in the study, and how the researchers tried to avoid bias. Bias is also something that you can discuss with the research team if you are considering being in a study or are currently a participant in a study.Related Terms: prejudice, tendency, preference, predisposition, favoritism", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biomarker", "definition": "Glossary Definition: Something in the body that is measured as an indicator of personal health or disease.Use in Context: Many different types of biomarkers can be measured in the body.More Info: Biomarkers can be found in blood, body fluids, or tissues. They are sometimes related to a particular disease or condition. A biomarker can show how the body is working, and provide information about health. Understanding biomarkers is important for developing new drugs and medical devices. Biomarkers are one way to figure out whether the drug or device is working as intended. For example, one biomarker is cholesterol. Cholesterol levels are a useful biomarker for heart disease. A research study might try to find out if a medication is helping lower cholesterol to prevent heart disease.Other Info to Think About When Joining a Study: A study that collects samples like blood or saliva from your body might be looking biomarkers. You can ask the study team any questions you have about the kinds of biomarkers that might be studied and whether any of the results will be returned to you.Related Terms: biological marker", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "birth control", "definition": "Glossary Definition: A way to prevent pregnancyUse in Context: Using birth control may be required in some drug studies.More Info: Birth control when any method, medicine, device, procedure, or behavior is used to prevent pregnancy. Contraception is a form of birth control. Sometimes birth control is needed in clinical trials if there is a possible risk to sperm or pregnancy development.Other Info to Think About When Joining a Study: A study you are thinking about joining may say that you need to use a birth control method. Some studies require a sexual partner to also use birth control. You can ask the study team to explain why birth control is needed. You could ask what kind of birth control the study will want you to be on. You could also ask what will happen if you do get pregnant while on the research study.Related Terms: contraception, pregnancy prevention, condoms, birth control pill, abstinence, hysterectomy, vasectomy, intrauterine device (IUD)", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "blood draw", "definition": "Glossary Definition: Taking a sample of blood by using a needle.Use in Context: A blood draw from a vein is often needed for lab tests.More Info: If a study includes a blood draw, it means one (or more) samples of the participant\u2019s blood will be taken for the research.Other Info to Think About When Joining a Study: Some research studies require one or more blood draws. The blood draw could happen at any study visit depending on the study you join. You can clarify if and when you need a blood draw during the study. You may also want to ask if you need to do anything to prepare, like skip a meal if it is a fasting blood draw.Related Terms: phlebotomy, blood sample", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical benefit", "definition": "Glossary Definition: A health change that researchers measure to show that the study treatment helps the study participants.Use in Context: A study treatment may have clinical benefit if participants have some kind of improvement.More Info: For example, the clinical benefit of a drug used in a diabetes study might be lowering and better controlling the blood sugar of participants.Other Info to Think About When Joining a Study: You may see the term \"clinical benefit\" when researchers describe what the study is trying to find out. In many cases what matters most to participants is understanding whether a study treatment will lead to having a clinical benefit like improved quality of life. You might want to ask if the study is measuring the clinical benefit of the study treatment.Related Terms: benefits of a research study, benefits, advantages, pros", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical research", "definition": "Glossary Definition: A type of science that uses people's data to study health, illness, behaviors, or conditions in careful and defined ways.Use in Context: Clinical research is an organized way to find out about a condition or disease, how the condition progresses, how a treatment is given, or which treatments are safe and work best.More Info: Clinical research includes many different types of studies, such as clinical trials, observational studies, and survey studies. Clinical research can be about individuals, populations, or public health.Other Info to Think About When Joining a Study: The term \"clinical research\" refers to any systematic way of studying health and illness. Clinical research is the way to learn more and find new medicines and treatments. You may hear this term if a researcher asks you to take part in a clinical research study. For example, your doctor may ask if you want to be involved in research and consent to join a study.Related Terms: health research, medical research, clinical trial, clinical study, research study, observational study, preclinical study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Clinical Research Coordinator (CRC)", "definition": "Glossary Definition: A research staff member who helps manage studies.Use in Context: A Clinical Research Coordinator works with the study doctor to help conduct the study.More Info: One or more CRCs is assigned by the Principal Investigator who is leading the research to take care of specific study tasks. Tasks include preparing study documents, scheduling study visits, and collecting data.Other Info to Think About When Joining a Study: When enrolling in the study and going to study visits, you may meet with the clinical research coordinator. They may be the person explaining the study and consent process to you. It may be useful to ask whether the clinical research coordinator is the person to contact if you have any questions about the study or any issues come up.Related Terms: project manager, study coordinator, research coordinator, research nurse", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial", "definition": "Glossary Definition: A research study that tests drugs, devices and treatments to see if they are safe and work in people.Use in Context: Participants in a clinical trial help the study doctor learn more about a new treatment.More Info: A clinical trial could study ways to diagnose, treat, or even prevent illness. Some clinical trials look at just one study treatment. Others might compare the study treatment to another treatment, a placebo, or even to a group that is taking nothing in order to measure how well the study treatment works.Other Info to Think About When Joining a Study: The term \"clinical trial\" is used for studies of people with various diseases and conditions. You might be asked if you want to take part in a clinical trial. You may also read it on flyers asking for study volunteers. It is important to understand the risks and benefits of the clinical trial before you enroll.Related Terms: research study, trial, clinical study, study, interventional study, clinical research study, clinical research, control, placebo", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinician", "definition": "Glossary Definition: A health care provider.Use in Context: A clinician has special medical training to care for patients.More Info: Clinicians include people who are doctors, medics, nurses, pharmacists, psychologists, physical therapists, occupational therapists, psychiatrists, and others.Other Info to Think About When Joining a Study: Any health care provider that you see regularly is a clinician. In health-related research studies, it may be a clinician who recruits and enrolls you. Additionally, a clinician may be in charge of a research study you join. You can ask for the name and contact information of the clinician(s) running the research study. You may also want to discuss being in a research study with your own clinician before consenting to join a study.Related Terms: allied health professional, healthcare provider", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cohort", "definition": "Glossary Definition: A group of study participants that are similar in some way.Use in Context: Data were collected from a cohort of people over the age of 65 to see if the participants developed health problems.More Info: A cohort is usually a group of people who are in an observational study to see how a disease or condition develops. A cohort is also the group of people in a clinical trial testing a study treatment for a specific disease or condition.Other Info to Think About When Joining a Study: You may hear the term \"cohort\" when the study team is describing the research study to you or when you are reading the study consent form. This term may come up when learning about the study groups and the different study treatments they may take or what different groups of participants may have to do differently. It can be helpful to ask why a specific cohort was selected for the study you are joining and what the researchers would like to learn.Related Terms: study cohort, study group, arm, observational study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Comparative Effectiveness Research (CER)", "definition": "Glossary Definition: A study comparing two or more treatments.Use in Context: A comparative effectiveness research study compares at least two treatments to determine differences in outcomes.More Info: Comparative effectiveness research compares treatments with drugs or devices, different ways to diagnose a condition, or how best to provide health care and services. An example of a comparative effectiveness research study would be comparing Advil, Aleve, Tylenol, and Aspirin to see which is better for treating headaches. Generally, a placebo is not used in comparative effectiveness research.Other Info to Think About When Joining a Study: If you are thinking about joining a comparative effectiveness research study, you should understand what study treatments are being compared and why.Related Terms: superiority trial, inferiority trial", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "comparator", "definition": "Glossary Definition: Something that is compared to the study treatment.Use in Context: Studies with a comparator are usually trying to find out if there is a different outcome in the comparator group versus the group that gets the study treatment.More Info: A comparator is also called a \"control.\" The group that gets the comparator is the \"control group.\" The comparator can be an investigational or approved medicine, a placebo, or a different procedure or intervention. For example, in a study of acupuncture for back pain, a comparator might be physical therapy or yoga.Other Info to Think About When Joining a Study: You may see the word \"comparator\" to describe another arm in the study. A comparator is often a treatment or intervention in common use and is used to see if the study treatment is worse, better, or somehow different. Feel free to ask any questions you might have about the comparator that is being used in a study.Related Terms: Control, Reference, Benchmark, Comparison, Study treatment, Test article", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "compensation (study)", "definition": "Glossary Definition: Money and other forms of payment that may be given to participants for completing study activities.Use in Context: Participants can ask the study team if compensation will be offered.More Info: Some studies offer payment to participants. Study team members should explain any likely costs to participants for being in the research, and whether compensation or payment will be offered. This information may also be in the research consent form. Compensation in research is meant to help cover out-of-pocket costs to study participants, such as transportation, parking, meals, childcare, and to offset time out of work. If the study is unable to provide compensation, study team members should explain why.Other Info to Think About When Joining a Study: As a participant, you may hear or read about \"compensation\" when thinking about joining a study. This information about payments might be in the consent form, and a study team member may discuss this with you during the consent conversation. If compensation is not mentioned, you should feel free to ask the study team if compensation or payment is provided. You may also ask how much compensation is provided, how the amount is determined, and what you need to do to ensure you can receive the compensation.Related Terms: Reimbursement, Payment, Incentives", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "compliance", "definition": "Glossary Definition: Following research requirements.Use in Context: Compliance with research rules and instructions improves the quality of a study.More Info: Compliance in research refers to following regulations and guidelines about research. Researchers must be in compliance with research requirements and follow the approved protocol. Compliance also applies to participants who should follow study procedures. The words 'adherence' and 'compliance' are often used in the same way.Other Info to Think About When Joining a Study: The consent form may say that the study team could remove you from the study if they notice your participation does not meet compliance requirements. Feel free to ask the study team for assistance is you are struggling with compliance due to issues such as lack of transportation, a reading disability, or just using new technology as part of the study. Keep the study team updated so they are aware of your situation. Both the researchers and participants need to be compliant with guidelines and protocols when they are taking part in the research. The study team will tell you that there are certain things you must do to be part of the research study. Following these rules means you are compliant with the study procedure. If you are unsure of what you should be doing during the study, ask the study team for more information.Related Terms: adherence, following the rules or the law", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Computerized Tomography (CT) scan", "definition": "Glossary Definition: A way to take pictures of the inside of a person's body using a type of radiation and a computer.Use in Context: A CT scan is able to show specific changes in a person's body (like changes in the brain, other tissues, organs or bones).More Info: A CT scan is a type of imaging study.Other Info to Think About When Joining a Study: A CT scan may be needed in a research study. If you know you have to get a CT scan for the research study, you can ask how the information will help the study. Also, you can ask if the CT scan results will be shared with you or your regular doctor, and how much radiation you will receive. This information could help you decide if you want to receive radiation from a CT scan done for research purposes.Related Terms: imaging study, X-ray, MRI", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "concomitant medications", "definition": "Glossary Definition: Non-study medicines that are allowed to be taken at the same time as the study treatment.Use in Context: Researchers need to know about any concomitant medications a participant is taking while in a research study.More Info: In research, concomitant medications are medicines that a participant takes at the same time as taking the study treatment. Concomitant medications are not the study treatment. The study team needs to know about all the medicines that are being taken to make sure that they do not interfere with the research. For example, if a participant takes a blood pressure medication, they should tell the study team and ask it is ok to keep taking it in the research study.Other Info to Think About When Joining a Study: Concomitant medications are reviewed by the study team to ensure that they are safe to take during the study It is important to tell the study team about your other medications to ensure it is safe to take them while on the study. If you join a research study and need to start a new medication, contact the study team first. If any new health issues arise, be sure to discuss them with the study team.Related Terms: usual medications, con-meds", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "conduct", "definition": "Glossary Definition: To do a study or procedure.Use in Context: The study team helps conduct the research.More Info: Depending on the study, the researcher may conduct a physical exam, survey, or interview to collect data for the research.Other Info to Think About When Joining a Study: The term \"conduct\" may come up in the consent form you are given when you're thinking about joining a study. It may mention that the study team is conducting this research or that your participation may help them conduct the research.Related Terms: perform, run, execute, implement, carry out", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "confidence interval", "definition": "Glossary Definition: The defined range of numbers used to describe where the results are expected to fall.Use in Context: A confidence interval is the range of values that a result is expected to fall in if the test is done again.More Info: A confidence interval is a measure of variability. It is the likelihood that a measurement, when repeated, will fall within a given range. It can help researchers know how much to trust that a result can be repeated. The smaller the confidence interval, the more certain the results are. The term \"confidence interval\" is often abbreviated as \"CI.\"Other Info to Think About When Joining a Study: The term \"confidence interval\" will usually appear in publications about research studies when the article discusses the statistics and results. The results section may provide more description about the confidence interval as well as define what it is for the specific study written about in the publication. The confidence interval could also be included in the Plain Language Summary explaining the study results.Related Terms: margin of error, probability, estimate", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "confidentiality", "definition": "Glossary Definition: Protecting personal information from people who should not have access.Use in Context: Confidentiality in research means researchers keep participant information private.More Info: Researchers protect confidentiality by not sharing personal details about study participants with people who do not need to know as part of their work on the research.Other Info to Think About When Joining a Study: Confidentiality is very important in healthcare and clinical research. When talking or reading about the data that you will provide during the study, the study team may mention how they will protect your confidentiality. You can always ask more about how the study team plans to protect your data and who will have access to it. Before you join a study, make sure you feel comfortable with how your data will be used and protected.Related Terms: privacy, non-disclosure, data", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "confounding", "definition": "Glossary Definition: When the study outcome is influenced by outside conditions that were not expected by the study researchers.Use in Context: Researchers try to be aware of possible confounding factors that can affect their study results.More Info: Confounding suggests there is a correlation between two or more things when really there is none. For example, alcohol use is associated with lung cancer. Alcohol is not known to be related to lung cancer, but people who smoke often consume alcohol. Smoking is the confounder here, related to lung cancer and associated with alcohol use.Other Info to Think About When Joining a Study: Researchers design studies to try to avoid the amount of confounding that could impact the study results. If you are thinking about enrolling in a new study, you might ask the study team how the study was designed to try to prevent confounding. Pregnancy is often considered a confounding factor for research. Some studies are designed to not allow pregnant people to participate because they aren't sure how the pregnancy would impact the results. If you are planning to become pregnant and are thinking about joining a study that does not allow pregnancy you should discuss this with the study team.Related Terms: correlation; causation; cause and effect; dependent and independent variables", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "consent form", "definition": "Glossary Definition: A document used to explain the planned research before a person decides whether or not to join a study.Use in Context: A person signs the consent form when they choose to take part in a study but only after they understand the information.More Info: A consent form for a research study explains the research, potential risks and benefits, and all the details of a study. The consent form also includes information about other treatment options, the rights of participants, and the rules that the researchers need to follow. A consent form can be on paper or an electronic document.Other Info to Think About When Joining a Study: Most clinical research studies require a person to read and sign a consent form. A member of the study team should explain the study in detail and answer any questions you have. You can ask for and keep a copy of the consent form from the study. Take the time to get your questions answered if anything is unclear so you understand what you will have to do during the study and how long the study is. Even after signing a consent form to join a study, remember you can withdraw from the study too. Just make sure to discuss with the study team so you can leave the study safely.Related Terms: informed consent form, informed consent", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Contract Research Organization (CRO)", "definition": "Glossary Definition: A group that is paid by the study sponsor to support research studies.Use in Context: A Contract Research Organization helps the sponsor run a study.More Info: A Contract Research Organization (CRO) can be a commercial, academic, or other group that is contracted by the sponsor to perform one or more research functions. A CRO works with the study teams and often helps coordinate multiple sites.Other Info to Think About When Joining a Study: When reviewing the consent form, it may say that there is a Contract Research Organization (CRO) involved. You could ask for more details about what the CRO is doing and what part they play in the study. You can also ask whether any participant information is shared with the CRO.Related Terms: sponsor, clinical research coordinator", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "contraindicated", "definition": "Glossary Definition: When things should not be used or done together because of possible harm.Use in Context: Researchers make sure that study procedures are not contraindicated before a participant enrolls in a study.More Info: Researchers carefully check whether participants are receiving treatment or have a condition that would be contraindicated for the study intervention. For example, a study of high-protein diets is contraindicated in people with kidney failure because high protein might harm the participant's kidneys. An action or procedure could also be contraindicated in certain situations. For example, an MRI is contraindicated in someone who has anything metal in their body.Other Info to Think About When Joining a Study: The study team may tell you there are certain medications you cannot take or foods you cannot eat while you are participating in the study because they are contraindicated. For your safety you may not be allowed to join a study because you have a condition that may be contraindicated. Be sure to ask for clarification if you are unsure about what may be contraindicated. See if there is a list that you can keep that reminds you of what is contraindicatedRelated Terms: harmful", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "control group", "definition": "Glossary Definition: The people in a study who do not receive the study treatment or do not have the condition being studied.Use in Context: A control group is used as a comparison to see the effect of the study treatment.More Info: Participants in the control group receive something different during the research study compared to the intervention group. The control group might receive a different dose, standard of care, a placebo or no treatment at all.Other Info to Think About When Joining a Study: Whether a research study has a control group is important to understand. You could ask if the study you are thinking about joining will have a control group. If there is, you could ask what being in the control group will involve. For example, being in the control group could mean getting a placebo or the standard of care for the disease the study is looking at. You can also ask how participants will be assigned to the control group. This is often decided randomly, using randomization.Related Terms: control arm, comparison group", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "correlation", "definition": "Glossary Definition: When two or more measures are linked.Use in Context: There is a correlation between height and weight in that taller people tend to be heavier.More Info: A correlation means that two things are associated. It does not mean that the one of the two things is caused by the other. A strong correlation means that two things are highly related A weak correlation means that two things are not very related. An inverse correlation means that as one thing increases, the other decreases.Other Info to Think About When Joining a Study: The term \"correlation\" may be used to discuss how certain conditions or situations relate to each other. You may also hear about correlations in the context of how study results are presented and discussed. For example, a study may try to find out whether the study intervention is correlated with some specific outcomes.Related Terms: relationship, association", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data", "definition": "Glossary Definition: Information collected from or about people taking part in a research study.Use in Context: Researchers use data to answer study questions.More Info: There are many different types of data including: personal information like age and date of birth, questionnaires, blood test results, imaging scans and their interpretations, health insurance status and so on. The types of data collected depend on the study.Other Info to Think About When Joining a Study: Analyzing data is the way research questions are answered. You will usually hear the term \"data\" when researchers talk about the information they will be collecting about you during the study You may want to clarify what data the study team will collect from you and how the data will be used for the research. You can also ask how the data will be protected and whether the data could be used for any other future uses.Related Terms: information, questionnaire, assessment", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB)", "definition": "Glossary Definition: An independent group of experts that reviews study data to make sure that patient safety is protected.Use in Context: A Data Monitoring Committee advises the study sponsor if any concerns about participant safety are found.More Info: Data Monitoring Committees (DMCs) are also called Data and Safety Monitoring Committees (DSMC) or Data and Safety Monitoring Boards (DSMB). Studies that are randomized controlled trials, higher risk, or enrolling vulnerable populations (eg. children) usually include DMCs to review the data at specific timepoints, especially for adverse events that can affect participant safety. The DMC reviews unblinded data on a regular schedule and as needed until the end of the study and advises on next steps in the event of adverse event(s). The DMC also looks at whether a study should be stopped early (for example, for safety reasons or if there is no benefit to the study treatment)Other Info to Think About When Joining a Study: You may see or hear about a Data Monitoring Committee (DMC) if you are enrolled in a study that has one. The DMC looks at all study data and may request that the study team give you important new information that is learned. If there are any safety concerns, the DMC may advise that the study should be ended early.Related Terms: DSMB, DSMC", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "database (research)", "definition": "Glossary Definition: Information that has been collected and organized to be used for research.Use in Context: A research database stores study information so that researchers can use it to answer study questionsMore Info: Participants are usually given a code during the study so their identifiers are not saved in the same place as the other study data. A research database usually has coded information about the participants to protect their privacy. A database can be used in the present or in the future to answer new questions.Other Info to Think About When Joining a Study: You will hear the term \"database\" used in many different ways during the research process. In research studies you may hear or read about the term \"database\" when the study team or consent form is describing how they will store data that is collected from the study. A database may also store personal information, like participant contact information. This information should be stored in a secure, protected way. You may want to ask how your data will be stored if you join the study. You can also ask the study team who has access to the database and what information they will keep in the database. Additionally, you may want to ask how they will keep the database safe and secure.Related Terms: data bank, registry, repository", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "discontinue (participant)", "definition": "Glossary Definition: To remove a study participant from a study.Use in Context: If a participant wants to stop being in a study, they should have a conversation with the study team about how to discontinue safely.More Info: A participant can decide to discontinue being in a study. Sometimes a participant is discontinued by the researchers for safety or other reasons. Reasons for discontinuing and the transition from the study should be discussed with the participant before they leave the study.Other Info to Think About When Joining a Study: The term \"discontinue\" can be used in research to describe either leaving the study or stopping the study treatment. If you decide to discontinue any part of being in a study, please discuss with the study team how to do so safely first. This is to make sure that there are no likely health risks from ending study participation.Related Terms: withdraw", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "discontinue (study treatment)", "definition": "Glossary Definition: To stop a study treatment in a participant.Use in Context: If a participant wants to stop the study treatment, they should first have a conversation with the study team about how to discontinue safely.More Info: A participant can decide to discontinue a study treatment. Sometimes a study treatment can be discontinued by the researchers for safety or other reasons. Reasons for discontinuing should be discussed before the study treatment is stopped.Other Info to Think About When Joining a Study: The term \"discontinue\" can be used in research to describe leaving the study or stopping the study treatment. If you decide to stop taking the study treatment, please discuss this with the study team first. This is to make sure that there are no likely health risks from stopping the study treatment. Please also discuss how stopping the study treatment affects your participation in the study itself.Related Terms: withdraw", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "disease progression", "definition": "Glossary Definition: An illness getting worse over time.Use in Context: Disease progression refers to a disease or condition getting worse for a patient.More Info: Disease progression can refer to a disease or symptoms getting worse. It can also refer to a person's functional abilities declining.Other Info to Think About When Joining a Study: Depending on the kind of study you are considering or reading about, you may see or hear references to \"disease progression\" during the informed consent process or other informational study materials. Disease progression may be used to explain the purpose of a study or explain the reason for particular procedures and tests. For example, a study could be collecting data on whether the disease progresses after taking a treatment. If you have any questions about what it means for a study to look at disease progression, you should ask the study team.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "disease-free survival", "definition": "Glossary Definition: The length of time after treatment that a person lives without the illness coming back.Use in Context: Some studies look at disease-free survival to see whether the drug works to keep a disease from coming back.More Info: Disease-free survival can be used to describe the length of time an individual or a group of participants within a study are free of their disease. Not every person in a study will necessarily have the same response to the study treatment.Other Info to Think About When Joining a Study: Depending on the kind of study you are considering or reading about, you may see or hear references to \"disease-free survival\" during the informed consent process or other informational study materials. \"Disease-free survival\" may be used to explain the purpose of a study or explain the reason for particular procedures and tests. For example, a study could be collecting data on disease-free survival after participants take a certain treatment. If you have any questions about what it means for a study to look at disease-free survival, you should ask the study team.Related Terms: relapse-free survival, remission", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dissent", "definition": "Glossary Definition: Refusing to be part of a research study.Use in Context: A child can dissent or refuse to participate even if their parent or guardian has consented for them to participate in a study.More Info: Children and adults who are unable to give legal consent may dissent to participate at any point during the research. Researchers should honor dissent whether it is communicated in a verbal or non-verbal way. A participant can dissent and withdraw from most research at any time. Sometimes, when the research is likely to provide benefit to the individual receiving the intervention, dissent may not be honored, but every effort should be made to explain the reason to the participant.Other Info to Think About When Joining a Study: The term \"dissent\" may be discussed when a parent or guardian reviews the consent form. You should know that even if a guardian provides consent, they have to ask the person who will be in the study if they want to be in the study or not. The person will either want to be in the study and assent or they may not want to be and dissent. You can ask if there is an assent process and what that process will be like. You may want to also ask what happens if the guardian gives consent but the potential participant dissents.Related Terms: object, say no, refuse, decline, disagree", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dose escalation study", "definition": "Glossary Definition: A kind of study where increasing amounts of a study treatment are given to different groups to find the best dose.Use in Context: In a dose-escalation study, the dose of a study treatment is increased one group at a time to find the best dose.More Info: In a dose-escalation study, the first participant (or group of participants) gets the lowest dose of study medication. The amount is increased with each participant or group to find the dose that gives the greatest benefit with the fewest side effects. This process can help researchers choose the best dose for future studies.Other Info to Think About When Joining a Study: If you are considering participating in a dose escalation study, you may have questions about how the dose levels were determined and what safety information already exists.Related Terms: Therapeutic Index", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "double-blind study", "definition": "Glossary Definition: A study that is set up so that the study treatment that each participant receives is not known by the participants or the researchersUse in Context: In a double-blind study, the study participants and the study doctor don't know which treatment each participant is getting.More Info: Double blind studies are done to minimize bias that can affect the study results. Bias can occur when participants or researchers know which study treatment participants are getting Participants can ask to find out which study treatment they received after the study ends.Other Info to Think About When Joining a Study: If you are considering joining a double-blind study you can ask questions about how your safety will be monitored. If there is an emergency, it is possible to find out what study treatment you are taking so you can receive the medical care you need.Related Terms: masked study, blinded study, masking, blinding, bias, single-blind study, randomization", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug holiday", "definition": "Glossary Definition: A time period decided between the participant and study team when a medication is stopped and then re-started.Use in Context: A person should always check with the study team and their doctor before stopping any medicine or taking a drug holiday.More Info: A drug holiday is a planned break from taking a medicine or study treatment. People may take a drug holiday for study reasons, a health issue, or personal reasons. For example, having surgery may mean that all current medications, including any study treatments, need to be paused. A person should not stop taking any prescription or study medications without first discussing with their doctor and the study team first.Other Info to Think About When Joining a Study: If you are in a research study and would like to take a planned \"drug holiday\" to stop taking the study treatment you should first discuss it with the study team. Any time you plan to pause any of your prescribed medications you should ensure this is safe with your regular doctor and discuss how to stop taking your medications safely. Feel free to ask any questions you have about taking a drug holiday.Related Terms: Medication vacation", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug therapy", "definition": "Glossary Definition: The use of medicine to treat a disease, condition, or symptom.Use in Context: Clinical trials are done to learn more about the risks and benefits of a drug therapy.More Info: There are many different types of drug therapy that can have multiples different purposes. A drug therapy could be used to: - make symptoms better, - treat a condition or disease, - lower the risk of getting a disease in the future, - or destroy harmful cells, like cancer cells.Other Info to Think About When Joining a Study: If a research study is testing a drug therapy it is important to understand the possible risks and benefits. You can ask questions during the consent process, but also anytime during the study if any new questions come up. The study team is there to make sure you stay safe while you are taking a drug therapy.Related Terms: Pharmacotherapy, Pharmaceutical therapy, Biologic, drug", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "e-consent (form)", "definition": "Glossary Definition: An electronic version of an informed consent form.Use in Context: An e-consent form can be useful in studies that are being conducted remotely.More Info: E-consent is a method of obtaining informed consent through the use of an electronic system instead of a paper consent form. Participants may sign the form electronically and then they may be able to get a copy emailed to them or download it themselves.Other Info to Think About When Joining a Study: A study may have an e-consent form to join a study. You could ask if you get a copy of the e-consent form and how you will get that copy. You could also ask if there is a paper version of the consent form for you if you want one.Related Terms: electronic informed consent, digital consent, consent form, decentralized clinical trials", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "effectiveness", "definition": "Glossary Definition: How well a treatment works.Use in Context: Effectiveness refers to how well a treatment, medicine or vaccine works in people who use it after it has been approved.More Info: Effectiveness refers to how well a treatment works in the real world, not in a planned clinical trial. Usually effectiveness is assessed after approval by health or government authorities.Other Info to Think About When Joining a Study: The word effectiveness commonly comes up in the context of already approved medications. In contrast, efficacy, refers to how well a study treatment works in a study. The words \"effectiveness\" and \"efficacy\" are sometimes used to mean the same thing even though they have slightly different meanings.Related Terms: Efficacy", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "efficacy", "definition": "Glossary Definition: How well a study treatment works in the study.Use in Context: A study tests efficacy to see how well a new treatment works.More Info: Efficacy is different from \"effectiveness\" which refers to how well the treatment works in the real world outside a study.Other Info to Think About When Joining a Study: The word \"efficacy\" can be used to describe how well the investigational intervention works in the controlled setting of a study. This term may be used when researchers describe an objective in the study. For example, a study could be testing the efficacy of a new vaccine.Related Terms: effectiveness", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eligibility criteria", "definition": "Glossary Definition: The reasons a person can be included in, or excluded from, a study.Use in Context: A study has eligibility criteria to make sure only people who fit the study requirements join as participants.More Info: The eligibility criteria for a study are made up of inclusion criteria and exclusion criteria. For example, a study may be looking to include only people of a certain age or with a certain health condition.Other Info to Think About When Joining a Study: If you are interested in joining a clinical trial, the study team will ask you some questions and possibly do some medical tests to make sure you meet the eligibility criteria. This is for your safety and for scientific reasons so participants all meet specific criteria. If you do not meet the eligibility criteria for one study, you can ask the study team if there are other studies that you could be a good fit for.Related Terms: inclusion criteria, exclusion criteria", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Emergency Use Authorization (EUA)", "definition": "Glossary Definition: A process to make a treatment or vaccine available during a public health emergency, before all research is complete, and before full approval is granted.Use in Context: Regulators decide whether to allow an Emergency Use Authorization.More Info: An Emergency Use Authorization (EUA) makes medical treatments and vaccines available when the public's health is at risk, such as during a pandemic. Under an EUA, medicines and vaccines are still being tested but the approval process is fast-tracked in order to make interventions available more quickly. An EUA applies to the USA only. Other countries have different rules and regulations.Other Info to Think About When Joining a Study: The term \"Emergency Use Authorization\" may be something you heard during the Covid pandemic. If a treatment or vaccine is made available under an EUA, you may hear that there are still research studies to collect more data about the product.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "endpoint", "definition": "Glossary Definition: A measure of the expected effect of the study treatment.Use in Context: An endpoint is one of the main questions the study is trying to answer.More Info: A study could have more than one endpoint. Some examples of endpoints that are used in studies include finding out more about about a disease or condition, participant quality of life, or symptoms.Other Info to Think About When Joining a Study: The term \"endpoint\" is used to describe what the study will be looking at to see if the study treatment had an effect. You could see this term in consent documents or other descriptions of the study, including study results reports. In general, the endpoint is reported as an average of all the data collected in the study. You may not have the same results as the overall study found. For example, a study treatment may have lowered blood pressure overall for study participants, but your blood pressure may not have changed while taking the study treatment. If you have any questions about the study endpoint, you can ask the study team.Related Terms: clinical endpoint, outcome, primary endpoint, secondary endpoint, surrogate", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "enroll", "definition": "Glossary Definition: The action of a participant joining the study after providing informed consent.Use in Context: If you enroll in a study, it means you decided to volunteer to be a participant.More Info: In order to enroll in a study, a person must meet the eligibility criteria. Study participation is your choice. It is voluntary. If the study includes randomization, this would be occur after the participant enrolls.Other Info to Think About When Joining a Study: You may hear the term \"enroll\" when the study team is asking if you want to join the research study. You may need to provide your informed consent by signing a consent form before you can enroll in the study. Do your best to understand everything you will be asked to do if you enroll in a study. Feel free to ask the study team any questions you have about the study. In many cases, you will be able to take the time to go home and think about it before deciding to enroll in a study.Related Terms: join, informed consent, consent form, eligibility criteria, inclusion criteria, exclusion criteria, randomization", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "epidemiologist", "definition": "Glossary Definition: A person who studies where, why, how often, and to what populations health concerns and diseases happen.Use in Context: An epidemiologist analyzes data to look for patterns and causes of diseases or other health conditions in large groups of people.More Info: Some studies include epidemiologists because they help search for the cause of a disease and identify who might be at risk. Epidemiologists also help figure out how to control or stop the spread of a disease.Other Info to Think About When Joining a Study: An epidemiologist tends to look at population health rather than individual health. If you learn that an epidpemiologist is a member of the study team, this means there is someone looking at how the disease or condition being studied affects large groups of people.Related Terms: Disease detective", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "equivalence", "definition": "Glossary Definition: When two or more things in a study are about the same.Use in Context: In clinical research, equivalence often refers to whether two study treatments are almost the same.More Info: Treatments, therapies, vaccines, evaluation methods and study groups do not have to be exactly equal in order to have equivalence. Instead, equivalence means that the treatments are about the same in terms of how they work for patients.Other Info to Think About When Joining a Study: You may see the word \"equivalence\" when a study is trying to see if two or more study treatments have the same effect, or if a study has shown there is equivalence between study treatments. You may want to ask about whether there are any known possible differences between study treatments that would be important for you to understand given your own personal health concerns and issues.Related Terms: similarity, resemblance, equivalence study, non-inferiority study, equal", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "equivalent (effect)", "definition": "Glossary Definition: The same or almost the same result.Use in Context: In research, an equivalent effect means that different study treatments or medication doses have about the same effect on patients.More Info: An equivalent effect doesn't mean two treatments are exactly equal. Two treatments are equivalent if they have about the same risks and benefits.Other Info to Think About When Joining a Study: The word \"equivalent effect\" could be used to explain that one study treatment has a similar effect as another one. You may want to ask about whether there are any known possible differences between study treatments that would be important for you to understand given your own personal health concerns and issues.Related Terms: same, similar, equal outcome", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "evaluate", "definition": "Glossary Definition: To examine, review, and understand.Use in Context: A study team member will evaluate the effect of the study treatment at participant study visits.More Info: The study doctor evaluates the participant's response and safety in order to decide whether to continue the participation in a research study. The researchers also evaluate the quality of the data from a study to analyze the outcome.Other Info to Think About When Joining a Study: You may see the term \"evaluate\" if you look up your study on clinicaltrials.gov or in the consent form. You may hear about participants being evaluated during the study based on certain measurements. This term may also come up when talking about evaluating the safety or efficacy of a new therapy or device If the consent form talks about evaluating the participant, you may want to ask how they will evaluate you. Additionally, if the researchers are evaluating the efficacy or safety of a study treatment or device, you may want to know more about how they are going to do this and how the data will answer the study questions.Related Terms: assess, check, check out, learn, judge, appraise", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exclusion criteria", "definition": "Glossary Definition: A list of reasons a person cannot be included in a study.Use in Context: If someone wants to join a study, they can not have any of the exclusion criteria.More Info: Exclusion criteria are reasons that researchers cannot include a person in a research study. For example, if a study is only enrolling adults with diabetes, a person who does not have the condition could not take part.Other Info to Think About When Joining a Study: You may see the term \"exclusion criteria\" when learning about reasons why you might not be able to be included in a research study. The study team will ask you some questions and possibly do some medical tests to confirm you can be included. This is for your safety and for scientific reasons to make sure you do not meet the exclusion criteria. If you are unable to join one study, you can ask the study team if there are other studies that could be a better fit for you.Related Terms: eligibility criteria, inclusion criteria", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "expanded access", "definition": "Glossary Definition: A process for a doctor to request an unapproved treatment for a seriously ill patient.Use in Context: Doctors can seek approval to use a study treatment outside of research via an Expanded Access application.More Info: Expanded Access is a path for a patient with an immediately life-threatening or serious disease or condition to access an investigational medical product (like a drug, biologic, or medical device). Expanded Access can make treatment outside of clinical trials possible when no other treatments are available and there is no clinical trial for the patient to join. Expanded Access is also called \"compassionate use.\" Expanded Access is a program for doctors to request treatments that are not yet approved for seriously ill patients. This request is made by a patient's doctors using the Expanded Access application. The company that makes the experimental drug also has to approve the request.Other Info to Think About When Joining a Study: The concept of \"Expanded Access\" may be discussed if you are seriously ill or have a life-threatening condition, and the available treatments do not work for you. \"Expanded Access\" may also be discussed with you if there is no clinical trial for you to enroll in. You can always discuss with your doctor if there is a new unapproved treatment that could be requested via expanded access. It is important to note that Expanded Access is for treatment; it is not considered research.Related Terms: compassionate use, emergency use, pre-approval access", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "experimental", "definition": "Glossary Definition: Something that is being tested in research but not yet proven.Use in Context: An experimental medicine is studied before it is approved.More Info: Experimental treatments go through research studies to make sure the risks and benefits to participants are better understood. Before a drug, vaccine, or device is approved by regulators for a particular use, disease, or group of patients it is considered to be experimental.Other Info to Think About When Joining a Study: Clinical research is designed to find out more about health, disease, prevention and treatment. The word \"experimental\" may be used to describe what a research study is testing, for example an experimental treatment. This means that the treatment has not yet been proven or approved but there is reason to believe that it might work well. Through research, experimental treatments can become approved treatments. If you have any questions about anything experimental in a research study, you should ask the study team.Related Terms: investigational", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exploratory research", "definition": "Glossary Definition: A process to find facts that can guide the design of future studies.Use in Context: Exploratory research is helpful to find out how to approach future research questions.More Info: Exploratory research clarifies the question to be solved. It does not result in final conclusions or solutions. Exploratory research can test whether a method or study design can be used, or whether an outcome can be measured in a reliable way. Sometimes exploratory research is done using samples stored in biobanks.Other Info to Think About When Joining a Study: You may see the term \"exploratory research\" to describe early research that was done to figure out processes and inform the next study. If you are thinking about joining a research study, you can always ask what exploratory research informed the design of the study, or what exploratory research might be conducted with the data that is collected during the .Related Terms: pilot, preliminary studies", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "focus group", "definition": "Glossary Definition: A group interview to learn what people think about a topic.Use in Context: A focus group offers participants a chance to discuss their experiences with each other and the researcher.More Info: A focus group is a way to get many different people together to hear about what they think about a certain topic. A focus group is usually led by a member of the study team. Since focus groups collect information from a few people at the same time it is important to respect everyone's privacy when participating and not share details about the other people outside the study.Other Info to Think About When Joining a Study: You may be asked to participate in a \"focus group\" as part of a study. You may ask any questions about the focus group such as what information will be collected, how data will be collected, whether the focus group will be recorded, whether there will be a note taker, and how many people will be in the room. You can also ask how the data will be used and/or shared, and how your privacy will be protected. Feel free to ask any questions you have about being in a focus group.Related Terms: group interview", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "frequency", "definition": "Glossary Definition: How often something happens over a period of time.Use in Context: The frequency of study visits should be clear to anyone joining a research study.More Info: Frequency refers to how many times something will happen. It also describes the number of times something occurs in a specific period of time.Other Info to Think About When Joining a Study: The word \"frequency\" can be used in many different situations. For example, this term could be used to talk about the \"frequency of study visits\" you may have to make if you participate in the study. This term could also be used to talk about how often you have to take the study treatment or how often you need to fill out a questionnaire. If you experience some type of symptom while taking the investigational product, the study team may ask about the frequency of these symptoms. If you have any questions about how often you have to do something in order to participate in the study, please ask with the study team.Related Terms: number, prevalence, recurrence, repeat, incidence", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "generalizability", "definition": "Glossary Definition: How research results can apply to people who were not part of the study.Use in Context: A study has generalizability if the results are useful and can apply beyond the original study participants.More Info: Ideally, research findings should have generalizability to people outside of the study. Good generalizability means research results can be broadly applied to a large number of people who are similar in some way . Poor generalizability means that the results can only be applied to the study population or very specific situation.Other Info to Think About When Joining a Study: You may hear the term \"generalizability\" when the study team is describing what they hope the outcome of the research study will be. You could ask the study team at the beginning of the study if they expect the research results to have generazability to larger groups. You can also ask how generalizable the results are likely to be. The word may also be used in publications about research, especially in the \"Discussion\" section.Related Terms: usefulness, meaning", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "genetic testing", "definition": "Glossary Definition: A medical test that could identify a health risk to a person or their biological family members by looking at their genes (DNA).Use in Context: Genetic testing is done on cells from blood, tissues, and other fluids from the body.More Info: In clinical research, genetic testing looks for changes in DNA that are different from what is most common. Genetic testing is done on DNA, which is the genetic material found in cells. DNA provides instructions for how the body grows and develops. Changes or differences in DNA are called variants. Some variants may be linked to increased risk for a disease and affect personal health. However, not every variant is understood or has a known health effect, and more could be learned about its effect in the future.Other Info to Think About When Joining a Study: You may hear the term \"genetic testing\" from both your regular doctors and researchers involved in studies. You may even hear about genetic testing kits that you can buy yourself. Some research studies may have genetic testing as part of the study or offer it to participants if they are interested. If genetic testing is part of a research study, you may want to ask more questions, including what information could be learned during testing, what different results could mean for you or your biological family members, and if there are any risks associated with the testing. Sometimes differences are found but whehter those differences are important is unclear. Discussing these possibilities with the study team could be helpful. You may want to ask if you will receive the results from genetic testing and if these results will be shared with anyone else besides the study team. You may also want to ask if there will be a genetic counselor to explain the results to you if the study team shares this information with you.Related Terms: variant, SNP, mutation", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "hazard ratio", "definition": "Glossary Definition: A measure of risk that compares two treatments in the same study.Use in Context: Studies with more than one group use hazard ratios to compare whether one group has more adverse events than the other.More Info: The hazard ratio is the relative risk of an event happening in one group compared to another. For example, in a drug study, the group getting the study treatment may have headaches two times more than the control population. The hazard ratio would be 2, meaning that the study treatment group has twice the chance of getting headaches compared to the comparison group.Other Info to Think About When Joining a Study: You might see the word \"hazard ratio\" in research reports and articles that describe the results of research studies. This is a technical math term and will not usually be used in materials designed especially for patients and participants. If you see this word in a study document for a study you are considering, enrolled in, or completed, you can ask the researcher or study team any questions you might have.Related Terms: progression-free survival, relative risk", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "healthy volunteer", "definition": "Glossary Definition: A study participant who does not have a disease or condition, including the one being studied.Use in Context: A healthy volunteer should not have any known diseases or conditions.More Info: A healthy volunteer may test the study treatment's safety or be the comparison (control) during the study.Other Info to Think About When Joining a Study: Some studies recruit healthy volunteers. You may see the term \"healthy volunteer\" in the consent form or other information about the study. If you are healthy and wish to volunteer for a study, you will be screened to make sure you meet the study criteria. Feel free to ask the researchers any questions you might have about what the study is about and what you will be asked to do if you join.Related Terms: participant, subject, study participant, research participant, research subject, study subject, healthy control", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "hereditary", "definition": "Glossary Definition: A parent's features and traits being passed to their biological children before birth.Use in Context: Traits that are hereditary include eye color and sometimes an increased risk of a certain disease.More Info: Some physical or behavioral traits are hereditary. This means the traits are transferred from the parents to their biological children through genes and before the children are born.Other Info to Think About When Joining a Study: You may see the term \"hereditary\" used in a variety of different situations. It could be used when explaining why a disease might develop or a study to look at hereditary condition. For example, hereditary may be used in a consent form to describe a type of disease that is being studied. If you are confused or have questions, you should feel free to ask your study team for more information.Related Terms: genotypic phenotypic, mental health, physical info, traits (the manifestation of genetic information)", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "hypothesis", "definition": "Glossary Definition: An idea that is tested in a research study.Use in Context: The hypothesis in a research study is tested to see if it is true or not.More Info: A hypothesis is sometimes described as an educated guess, idea, or question that is a starting point for research. The hypothesis is usually presented as a statement, that is tested during the research. For example, a research study may have the hypothesis that one treatment causes fewer side effects than another. The study would be designed to test whether that is true.Other Info to Think About When Joining a Study: The word \"hypothesis\" may be used in discussions about what researchers are trying to learn through the study. You may see this word in the title of the study you are thinking of participating in or in the background information You may also hear the study team talking about testing their hypothesis through the research. The word \"hypothesis\" can also appear in publications about the statistics and data collected from the study. You can always ask the study team about the hypothesis that is being tested through the research.Related Terms: premise, supposition, thesis, theory", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "immune response", "definition": "Glossary Definition: The body\u2019s reaction to a substance, illness, or infection.Use in Context: An immune response is the body's way to fight something it thinks might be harmful.More Info: The immune response is how the body identifies and defends itself against germs like bacteria, viruses, and substances that seem to be harmful. An immune response helps the body stay safe. For example, a vaccine works by causing an immune response so that the body can fight off the germ, and remember to attack it if the germ ever comes back.Other Info to Think About When Joining a Study: You may see the term \"immune response\" used in a variety of ways in the research study context. For example, a study may be researching participants' immune responses to certain things or how different investigational products may affect a person's immune response. If you have questions about a study that is looking at immune response, be sure to ask your study team for more information.Related Terms: Immune system, antigen, antibody", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "incentive", "definition": "Glossary Definition: Something that supports or encourages research participation.Use in Context: An incentive to join research might be to help researchers learn more about a condition or find a new treatment.More Info: Incentives for research participation can be feeling good personally, receiving a gift card or payment, or getting entered into a raffle. Incentives can also include payment beyond the costs of participating or access to free medication. Incentives often help enrollment. A participant should never feel that an incentive pressures them to join the study or remain in the study.Other Info to Think About When Joining a Study: You may hear the term \"incentive\" before you enroll in a study. The study team may provide incentives for you showing up to study visits or when you complete the study. You may want to ask if study incentives could impact your eligibility for any social benefits if you are using things like SNAP or are on disability. Incentives can be in the form of money and may need to be reported on your taxes. You should feel free to discuss with the study team whether any kind of incentive will be offered and in what form.Related Terms: offer, motivation", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "incidence", "definition": "Glossary Definition: Number of new cases or events during a period of time.Use in Context: The incidence rate tells us how many new cases of a specific disease or condition develop during a certain period of time.More Info: Measuring the incidence is a way to keep track of how many new cases or events happen in a population at risk during a given time period. The incidence is generally reported as a rate. For example, in a study with 10 participants, if 3 people report headaches after taking the study medication and 7 do not, the incidence of headaches is 30% (3/10 = .3 or 30%)Other Info to Think About When Joining a Study: You might see the word \"incidence\" used to describe the frequency of a disease or condition. The word can also be used to describe the expected or actual number of adverse events in a study.Related Terms: frequency, rate, prevalence", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "inclusion criteria", "definition": "Glossary Definition: A list of requirements a person must meet to take part in a study.Use in Context: If someone wants to join a study, they must meet all the inclusion criteria.More Info: For example, if a study is for adults only, a person can only consider joining if they are 18 years of age or older.Other Info to Think About When Joining a Study: You may hear the term \"inclusion criteria\" when researchers talk about who can join a study. There may be reasons why a person cannot be included in a research study. Before you join a study, the study team will ask you some questions and possibly do some medical tests. This is for your safety and for scientific reasons to confirm that you meet the requirements of the study.Related Terms: eligibility criteria, exclusion criteria", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "informed consent", "definition": "Glossary Definition: The process of learning and discussing the details of a research study before deciding whether to take part.Use in Context: Informed consent is required for most research studies before a person can join as a participant.More Info: Informed consent is an ongoing conversation that occurs before someone can participate in a study and whenever information about the study changes. A consent form is used as part of the informed consent process.Other Info to Think About When Joining a Study: You may hear about \"informed consent\" often before you join a research study, and throughout your participation. A member of the study team will explain the research and answer any questions you have. Before you agree to join a study, you should understand what the research is about and what you will need to do if you enroll. Do not be afraid to ask as many questions as you need to. Someone from the study team should answer and clarify anything that is confusing. You can also take time to think about whether you want to join a study or not.Related Terms: consent, consent form", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "infusion", "definition": "Glossary Definition: A way to give a fluid to the study participant, usually through a vein.Use in Context: A study treatment given to a participant through their vein is an infusion.More Info: In an infusion, the fluid could be a study treatment or other liquids, like ones that are given for hydration.Other Info to Think About When Joining a Study: The term \"infusion\" will be used if there is a study treatment that is given through an infusion. If you are thinking about joining a study that has one or more infusions, you can ask what the infusion is for and what it contains. You can always ask the study team to clarify any study procedures.Related Terms: intravenous infusion, intervention, intravenous injection", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Institutional Review Board (IRB)", "definition": "Glossary Definition: A team of people who review studies to protect the rights and welfare of study participants.Use in Context: Participants can only enroll in a study after an IRB reviews and approves the study protocol.More Info: A research study must be approved by an IRB before it starts. The IRB members are not part of the study team. IRB members come from many different backgrounds and can be medical, scientific or non-scientific experts.Other Info to Think About When Joining a Study: You may see the term \"institutional review board\" in the consent form in a section about which group approved the study. You may also hear members of the study team talk about the IRB and getting the IRB's approval before any study activities can take place. The contact information of the IRB that is overseeing a study should be included in the consent form. You can reach out to the study's IRB if you have any concerns or complaints about your experience being in a research study.Related Terms: committee for the protection of human subjects, independent ethics committee, independent review board, research ethics committee, ethics committee", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "intermittent", "definition": "Glossary Definition: Not regular or predictable.Use in Context: The participant reported intermittent dizzy spells since the last study visit.More Info: When something is intermittent, it means that it happens more than once, but does not happen on a schedule, is not planned, and is not predictable.Other Info to Think About When Joining a Study: The term \"intermittent\" may come up when discussing adverse events that could happen during a research study. You can always discuss with the study team any questions you have about the possible adverse events in a study.Related Terms: time to time, randomly, occasionally, on and off, every so often, Infrequently", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigational medicine", "definition": "Glossary Definition: A treatment or drug that is not yet approved for the condition being studied.Use in Context: Being in a research study is one way a patient might have access to an investigational medicine.More Info: Every country has health authorities or government agencies that review and approve studies of investigational medicines. They then use the study data on risks and benefits to decide whether the investigational medicine is safe and effective and whether it can be approved for the condition or purpose.Other Info to Think About When Joining a Study: You may learn about an \"investigational medicine\" if you are thinking about joining a study that is looking at a treatment that is not yet approved. Your doctor or the study team may mention the investigational medicine in discussions or in the consent form. You could ask the study team to explain more about why the investigational medicine is being studied. You may also want to ask about how the investigational medicine has been studied before and what the study objectves are.Related Terms: investigational use, experimental drug/medicine, study treatment, intervention, investigational product, investigational drug, study medication, study medicine, drug candidate", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Investigational New Drug (IND) application", "definition": "Glossary Definition: An application to the United States Food & Drug Administration (FDA) to get permission to use a drug in a research study that enrolls people.Use in Context: Researchers submit an Investigational New Drug application to the FDA to get permission to study a new use for a drug.More Info: The Investigational New Drug (IND) application is specific to the United States (US). Researchers testing a new drug, or an approved drug for a new use, must get approval of an IND from the US Food and Drug Administration (FDA). The FDA is a government agency that regulates drugs and devices that are used in patients. Once approval is obtained, the research is often said to be conducted \"under an IND.\" Similar processes exist elsewhere in the world. For example, in Europe approval is obtained via a Clinical Trial Application (CTA).Other Info to Think About When Joining a Study: If you join a study that is testing a medicine under an Investigational New Drug (IND) application you should feel free to ask about what safety information about the study treatment is already known, and why this particular medicine is being tested. You can also find out more about the risks and what kind of care you can expect to receive if there are any adverse events.Related Terms: investigational medicine", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigational product", "definition": "Glossary Definition: A drug, device, vaccine, or other treatment being tested in a study.Use in Context: The investigational product is what is studied in a clinical trial.More Info: The Investigational New Drug (IND) application is specific to the United States (US). Researchers testing a new drug, or an approved drug for a new use, must get approval of an IND from the US Food and Drug Administration (FDA). The FDA is a government agency that regulates drugs and devices that are used in patients. Once approval is obtained, the research is often said to be conducted \"under an IND.\" Similar processes exist elsewhere in the world. For example, in Europe approval is obtained via a Clinical Trial Application (CTA).Other Info to Think About When Joining a Study: If you join a study that is testing a medicine under an Investigational New Drug (IND) application you should feel free to ask about what safety information about the study treatment is already known, and why this particular medicine is being tested. You can also find out more about the risks and what kind of care you can expect to receive if there are any adverse events.Related Terms: investigational treatment, study treatment, intervention", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigator", "definition": "Glossary Definition: A person who leads a research study.Use in Context: The investigator is responsible for making sure the study is carried out as planned.More Info: A study can have many investigators. An investigator could be a doctor, scientist, or other health professional. A principal investigator is in charge of making sure the whole research study is being conducted correctly.Other Info to Think About When Joining a Study: You may hear the term \"investigator\" when you learn about the different people involved in doing a study. The investigator who is running the study may be listed in the consent form.. You can ask for the investigator's name and also find out who you should contact in case you have any problems or questions during the study. It may be someone other than the investigator.Related Terms: researcher, study doctor, principal investigator, sub-investigator, co-investigator, coordinating investigator, site investigator", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "longitudinal study", "definition": "Glossary Definition: Research that collects data from the same participants over a long time.Use in Context: A longitudinal study collects information from a group of participants over a given period of time.More Info: Longitudinal studies help researchers see how specific factors about participants change over time. Longitudinal studies can be many weeks, months or years, depending on the topic being studied. For example, enrolling 3 year old children to see whether a specific early childhood education program affects later learning is a longitudinal study. Another example is finding out whether a study treatment prevents a disease from getting worse over time.Other Info to Think About When Joining a Study: If you are considering joining a longitudinal study you should ask questions about how long the commitment is and what will be expected. A research study may have the term \"longitudinal\" in its title or used to describe follow-up study visits. If you have questions about how this term is used, ask the study team before deciding to join this study.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Magnetic Resonance Imaging (MRI)", "definition": "Glossary Definition: A way to take pictures of the inside of a person\u2019s body with a machine that uses strong magnets and radio waves.Use in Context: Magnetic Resonance Imaging (MRI)I is most often used to take pictures of bones, tissues, organs or the brain.More Info: During an MRI, powerful magnets and radio waves are used to create very detailed pictures of the inside of a person's body. MRIs do not involve radiation. An MRI may be done as part of screening, or as a way to collect data about a participant throughout the study.Other Info to Think About When Joining a Study: You may have heard the term \"MRI\" when talking to your regular doctor. Some research studies may involve getting an MRI. If you have an MRI you will not be exposed to any radiation. You can ask why a study is using MRIs. You may also want to know if the study team will share your MRI pictures with you or your regular doctors. In general, MRI research scans are done for the research and not to identify specific health problems. If you have concerns about your health, please discuss them with your regular doctor.Related Terms: imaging study, CT scan, X-ray", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "master protocol", "definition": "Glossary Definition: An overall research plan that guides sub-studies that have their own research questionsUse in Context: A master protocol includes information about more than one study and allows the research to happen more quickly.More Info: A Master Protocol is the main protocol that guides sub-studies that can each be done at the same time. Master Protocols are used because they can help get answers more quickly and efficiently. They generally need fewer participants and offer more study options. Basket Trials, Umbrella Trials, and Platform Trials are all types of Master Protocols.Other Info to Think About When Joining a Study: You may see studies refer to a \"Master Protocol.\" These studies will have sub-studies that participants join. You can ask all about how the studies are designed, whether you can choose which sub-study you will be in, and how your experience in one sub-study may be different from other sub-studies.Related Terms: basket trial, umbrella trial, platform trial", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "maximum", "definition": "Glossary Definition: The most or largest amount.Use in Context: A study treatment should have the maximum benefit without causing serious side effects.More Info: The word \"maximum\" can refer to anything that is measured. In a study, it may be the \"maximum age\" of participants eligible for the study, or the \"maximum dose\" permitted, or the \"maximum amount of blood\" that may be taken at any one time.Other Info to Think About When Joining a Study: You may see the term \"maximum\" used in a variety of different ways. For example, the study team may talk about the maximum dose of a medication you can take. Or they may talk about the maximum number in a range of results from some type of research test. If you are unclear about how the study team is using the word, please ask them to explain more.Related Terms: most, largest, greatest", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mean", "definition": "Glossary Definition: The average.Use in Context: In math, the mean is the average value of a set of numbers.More Info: The mean is calculated by adding all the numbers in a set together, and dividing by the number of values. For example, in a group of four people who are aged 10, 20, 30, and 40, the mean (or average) age of the group members is 25. This is calculated by first adding all four numbers together, and then dividing by 4. So, 10 + 20 + 30 + 40 = 100. And 100/4 = 25. Thus, the mean, or average age, is 25.Other Info to Think About When Joining a Study: You may see the term \"mean\" used to describe an average of all the study data using numbers. You may see this term used in study results reports. If you receive study results that report the mean of any data and you have questions about that information, you can reach out to the study team to learn more.Related Terms: average, median", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "median", "definition": "Glossary Definition: The middle number in a set of numbers when listed in order from lowest to highest.Use in Context: In math, the median is the middle number in a set of numbers.More Info: The median is the middle, and it is not the same as the mean or average. For example, 5 is the median in the set of numbers 2, 3, 5, 30, and 50, because 5 is in the middle when the numbers are ordered from lowest to highest. Finding out the median can be useful if there are data that are outside the expected range. In the example above, 5 is the median, and that is far lower than the mean of 18 (that is, 2+3+5+30+50= 90; 90/5=18), showing that the data are not evenly spread out.Other Info to Think About When Joining a Study: You might see the term \"median\" used to describe the the middle number in a set of data. You may see this term used in study results reports. If you receive study results that report the median of a data set and you have questions about that information, you can reach out to the study team to learn more.Related Terms: middle", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "minimal", "definition": "Glossary Definition: Very small.Use in Context: A participant must report every adverse reaction even if the impact on their lives seems minimal.More Info: The risks of a study are minimal or very small if they are about the same as the risks of daily living. Adverse events may be described as minimal if they don't last very long or are mild. Some research is considered to be minimal risk, meaning the risk to participants should not be very high.Other Info to Think About When Joining a Study: You may hear the term \"minimal\" when discussing whether a study is minimal risk or not. If you have any questions about the risk of the study or otherwise how the word \"minimal\" is being used, you should feel free to discuss it with the study team.Related Terms: limited, negligible", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "minimum", "definition": "Glossary Definition: The smallest or least amount.Use in Context: A research study needs a minimum number of participants so enough data can be collected to answer the study questions.More Info: The word \"minimum\" can refer to anything that can be measured. For example, in a research study the \"minimum age\" in eligibility criteria is the youngest age that is allowed for a person to be enrolled.Other Info to Think About When Joining a Study: The term \"minimum\" may be used in a variety of contexts. For example, the study team share information about the minimum amount of time you have to do a study task. They might also talk about the minimum age for study participants. If you are unclear about how the study team is using the word, please ask them to explain more.Related Terms: least, lowest", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "minor", "definition": "Glossary Definition: Someone considered too young to give legal consent.Use in Context: A minor is a person who is under the legal age of majority in a specific place.More Info: Studies that enroll children need to have processes in place to ensure a parent or a guardian gives consent. The minor, when appropriate, is asked for their agreement before they are enrolled in the study. This is called assent.Other Info to Think About When Joining a Study: \u201cMinor\u201d is another word for child or pediatric participant. If you are a parent or guardian with a child who may join a research study, you can ask any questions, such as whether if there is a separate assent process for the child and whether there are additional protections for children.Related Terms: assent, child, young person", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "monitor", "definition": "Glossary Definition: To observe, check or evaluate something in a study over time.Use in Context: In ongoing studies, researchers have a responsibility to monitor the study participants.More Info: Participants might have their health and safety monitored depending on what type of study they are in. Data can be monitored as well to make sure they are being collected and stored correctly.Other Info to Think About When Joining a Study: The word \"monitor\" is often used to describe the steps and processes that will be followed to make sure participant safety is being protected and the study is being conducted properly. You can always ask the study team about how your safety and well-being will be monitored and how the study team will monitor the overall study.Related Terms: audit, investigate, assess, watch, oversee, observe, evaluate", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "morbidity (rate)", "definition": "Glossary Definition: The number of people who develop a disease or illness in a group over time.Use in Context: The morbidity rate in a study refers to how many people have or develop a condition.More Info: The morbidity rate is calculated by counting how many new cases or illnesses occur in a given number of people in a certain amount of time. Morbidity can also refer to medical problems caused by a treatment. For example, if 100 people get a rash from a new medication in a study of 1000 people, the morbidity rate of rash is 10% (e.g., 100/1000=1/10 or 10%).Other Info to Think About When Joining a Study: In the clinical research context, the term \"morbidity rate\" can be found in study descriptions. A study could be looking at ways to decrease the number of people developing a disease or illness. Sometimes you might see the term \"morbidity rate\" used in study results as well to describe how many participants develop new diseases or illnesses, or even how the morbidity rate of the study compares with the general public or other groups. If you see this term when you are reviewing a research document, you can always ask the study team about how it might be important for your participation in the study.Related Terms: illness rate, mortality", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mortality (rate)", "definition": "Glossary Definition: The number of deaths in a group of people over time.Use in Context: The mortality rate in a study refers to how many people died over the course of the study.More Info: The mortality rate is calculated by counting how many deaths occur in a group of people during an amount of time. For example, if 6 people died in a study of 200 people, the mortality rate would be 3% (e.g., 6/200=3/100=3%)Other Info to Think About When Joining a Study: In the clinical research context, the term \"mortality rate\" can be found in study descriptions. A study may look at ways to decrease the number of deaths (\"mortality rate\") in a group of people or from a specific cause. The term may also be used to describe how many participants died over the course of the study. If you see this term when you are reviewing a research document, you can always ask the study team about how it might be important for your participation in the study.Related Terms: death rate, morbidity", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "multicenter trial", "definition": "Glossary Definition: A study that takes place at more than one research center.Use in Context: A multicenter trial can be done in many locations in a country or even around the world.More Info: A multicenter study is a way to conduct research at more than one research center or site to make sure there are enough participants and people from many different backgrounds. A research center can be hospital, clinic, or research institution.Other Info to Think About When Joining a Study: You may hear the term \"multicenter study\" when the study team describes what kind of research study you could join or when you are reading the consent form. If a study is multi-center, you could ask what the other study locations there are. You may want to clarify who the investigator is at your research center and who to contact if you have questions.Related Terms: multi-site study, investigator", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "negative test result", "definition": "Glossary Definition: A test result that shows a person does not have what was tested for.Use in Context: A negative COVID test means that the person most likely does not have COVID.More Info: A negative test result for a disease, condition, genetic marker, or biomarker means that a person likely does not have the condition being tested for. A \"false negative\" means that the test incorrectly found someone to be negative when they are actually positive. Tests try to reduce the number of false negatives.Other Info to Think About When Joining a Study: You may see the term \"negative test result\" in the context of study screening or a study procedure. You may want to ask if you will get the test result and if yes, how long it will take for the results to be ready. If you have any questions about this test result you should discuss with the study team.Related Terms: sensitivity, specificity, false negative", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "negligible", "definition": "Glossary Definition: So small that it has little to no impact.Use in Context: Some research results are negligible in terms of what they mean for patient care.More Info: If an event, effect, or result is negligible, it is not considered important or impactful.Other Info to Think About When Joining a Study: The word \"negligible\" could be seen in the context of clinical research study results to describe that a difference between data or outcomes is so small that it is unlikely to have an impact on patient care.Related Terms: unimportant, insignificant, inconsequential, minor, minimal", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "non-compliance", "definition": "Glossary Definition: Not following research requirements.Use in Context: Non-compliance with the research protocol can impact the outcomes of the research.More Info: Non-compliance can apply to either researchers or participants not following the study requirements. Researchers must comply with the laws and regulations of research and the protocol as written. Participants must comply with study procedures. Participant non-compliance could result in the principal investigator removing a participant from the study for not following the study instructions. Regulators, sponsors or the IRB could check a research team for non-compliance with research laws and regulations.Other Info to Think About When Joining a Study: You might hear the term \"non-compliance\" when study team tells you about things you should do while in the study in order for the data to be complete. If you do not do these things, non-compliance could be an issue. For example, the study team may say you have to take an investigational medicine 3 times a day. If you only take it twice a day, it would be considered non-compliance with the study procedures. There may also be things you cannot do while you are in the study and if you do them, that is also considered non-compliance. Before signing up for a study, be sure to ask for clarification if you are unsure about what you need to do while you are in the study and what you cannot do. You may also want to ask what will happen if you are non-compliant. For example, if you have to take the investigational medicine once a day but you forget to, you can ask the study team what you should do in that situation.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "non-inferiority trial", "definition": "Glossary Definition: A study to test if a study treatment works about as well as another treatment for the same condition.Use in Context: One example of a non-inferiority trial would be to test whether a new medicine for asthma works as well as one that some patients already use.More Info: Non-inferiority trials are done to find more treatment options that work as well as ones that are already approved for a specific disease or condition.Other Info to Think About When Joining a Study: If you are considering joining a non-inferiority trial this means that the study will be looking at whether one treatment is as good as another. You should ask the study team any questions you have about the treatments being studied or how you will be assigned to a study arm.Related Terms: non-inferiority study, superiority trial, equivalence trial, control", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "objective", "definition": "Glossary Definition: A purpose or goal of a study.Use in Context: The research objective is the scientific question to be answered by the study.More Info: The study protocol always includes the objective(s) of the research. For example, an objective could be to find out whether a study treatment causes a certain symptom to get better.Other Info to Think About When Joining a Study: You might see the word \"objective\" in the consent form or study protocol. You could also hear about the objectives when speaking with the study team. The objective of the study refers to what the study is trying to find out. If you participate in a study you should undertsand the objective and ask the study team any questions you might have.Related Terms: study objective aim, goal, purpose", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "observational study", "definition": "Glossary Definition: A study that collects health information about study participants without giving a treatment.Use in Context: In an observational study, data will be collected about each participant but no one will be assigned to get a study treatment.More Info: For example, a study to see whether those who smoke cigarettes report higher rates of lung cancer than those that do not would be an observational study. Data are collected using methods like surveys and lab tests, as well as from other sources like medical records and historical datasets.Other Info to Think About When Joining a Study: If you enroll in an observational study this means data will be collected about you but no study treatment will be assigned. You may want to ask how the research team will collect data from you during your time in the observational study.Related Terms: natural history study, cohort study, case control study, empirical study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "observe", "definition": "Glossary Definition: To watch or see how participants are doing in a study.Use in Context: Participants may be observed for a few minutes after taking the study treatment to check for any early adverse reactions.More Info: To observe participants is one way to collect and document data for a study in a planned way.Other Info to Think About When Joining a Study: The study consent form or any information the study team gives you about the study you are participating in may mention that you will be observed. This could happen the first time you take an investigational medicine or after you take part in some type of research test. You can ask how long you will need to be observed if that is something that will happen to you. For example, after getting a vaccine, you may have to be monitored for some time to make sure you have no reactions.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "occasionally", "definition": "Glossary Definition: Once in a while.Use in Context: Occasionally there are changes in the study that require participants to re-consent to continue.More Info: The protocol and consent form will discuss how often certain procedures or possble harms will happen. If the frequency is described as being ocassionally, it means an event won't happen that often or predictably.Other Info to Think About When Joining a Study: The word \"occasionally\" can be used to describe how often an adverse event occurred in a research study. You might want to know more about what that frequency could mean if you take a particular study treatment.Related Terms: Sometimes, infrequent, rare", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "odds ratio", "definition": "Glossary Definition: The chance of a health event happening in one group compared with the chance of the same event happening in another group.Use in Context: An odds ratio is a measure of the link between an exposure and an event.More Info: An odds ratio compares the odds of two different groups. It is used to describe the association of exposure to one variable of interest (e.g. health characteristic, aspect of medical history) to a disease or disorder, compared with the lack of the variable with the disease or disorder. It also looks at the strength of that association. The odds ratio can also be used to determine whether a specific exposure is a risk factor for a particular outcome. For instance, the ratio of the odds of lung cancer in smokers divided by the odds of lung cancer in non-smokers is 14. Two events are not related if the odds ratio equals 1, i.e., the odds of event are the same in either the presence or absence of the other event. If the odds ratio is greater than 1, thentwo events are positively associated (correlated) i.e. The presence of one event increases the chance of the other one being present.Other Info to Think About When Joining a Study: You may see the term \"odds ratio\" when reading results information of a research study. The results section of a publication will talk about the data and statistics. \"Odds Ratio\" is a technical math term and will not usually be used in materials designed especially for patients and participants. If you see this word in a study document for a study you are thinking about joining, enrolled in, or completed, you can ask the researcher or study team any questions you might have.Related Terms: relatedness, relationship", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "off-label", "definition": "Glossary Definition: The use of a treatment in a different way or for a condition other than what it is approved for.Use in Context: Doctors can prescribe a medicine or other treatments off-label.More Info: The \"label\" in \"off-label\"refers to the specific, intended use that the medicine or product has been approved for. This approval is given by regulators, health authorities or government agencies. This applies to drugs and devices. A doctor may prescribe a drug off-label when there is reason to believe that the drug could be helpful when used in a new or different way or for a different condition, as in a different age group, dosage, way to take it, or condition.Other Info to Think About When Joining a Study: Some research studies are investigating a treatment that is being given as an \"off-label\" use. You can ask the study team what the treatment is approved for and what its intended use is. You may also want to ask why they want to use this treatment off-label and what information they may have that could suggest it would work off-label.Related Terms: off-label use, unapproved, unapproved use, intended use", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "open-label", "definition": "Glossary Definition: A type of study where participants and research staff know which treatment participants are being given.Use in Context: When a study treatment is open-label, participants know what they are taking.More Info: Open-label studies are used in a number of settings, including to learn about the long-term effects of study treatments. Sometimes it is impossible to mask which treatment a person will receive. Sometimes participants who have finished the treatment part of the stud keep sharing data so researchers can see how long the effects of treatment last.Other Info to Think About When Joining a Study: Some research studies are investigating a treatment that is being given open-label, without masking what the participant is receiving. If you are participating in a research study that is testing a study treatment, you can ask the study team whether you will be able to continue taking the treatment as an open-label use.Related Terms: unblinded, unmasked", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outcome (of study)", "definition": "Glossary Definition: A description of the overall results of the study.Use in Context: The study outcome describes what the researchers learned from the research.More Info: The study outcome will report the study results, such as whether or not a study treatment helped participants.Other Info to Think About When Joining a Study: You might see the word \"outcome\" when you read about a research study's results and the overall conclusions that researchers came to based on the study data. If you have any questions about the outcome of the study and what a study's results mean for you, you can ask the study team or discuss with your regular doctor.Related Terms: result, endpoint, primary endpoint, surrogate, secondary endpoint, clinical endpoint", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outcome measure", "definition": "Glossary Definition: The way that a study endpoint is measured.Use in Context: An outcome measure is used to collect data for the study.More Info: A study will use one or more outcome measures to collect the data that is needed to answer the research questions. For example, an outcome measure could be a blood test to find out how well the study treatment works to lower cholesterol.Other Info to Think About When Joining a Study: An outcome measure can be a questionnaire, survey, or any kind of assessment that is done to see any changes over the course of the study. Example of assessments include blood test, blood pressure reading, MRI, etc. If you have any questions about the outcome measures being used in a study, feel free to ask the study team.Related Terms: questionnaire, assessment, survey, data, endpoint", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "p-value (probability value)", "definition": "Glossary Definition: A number that researchers use to show that a result did not occur by chance.Use in Context: The p-value is used in research to show whether a difference in effect between treatments is due to chance.More Info: The p-value is part of the scientific process. It is a number used when analyzing research data and reporting research results. The p-value shows whether the results could have occurred by chance. When a p-value is very small, it means that it is less likely to have occurred by chance. For example, if a study has a p-value of 0.05, this means that if you did the study 100 times, the results would likely be the same 95 times. It is important to note that even if something has a small p-value and is statistically significant, the result may not make a big difference to patients. For example, a drug may shrink a tumor but not extend a person's life.Other Info to Think About When Joining a Study: You might see the term \"p value\" in a publication about research where the study results and statistics are reported. The article may include a results section that has more information about what the p-value for the study is and what that means for the results. The p-value could also come up in Plain Language Summaries of a study's results If you have any questions about how the p-value is being reported, feel free to talk to the study team.Related Terms: statistically significant", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "participate", "definition": "Glossary Definition: To take part in a study.Use in Context: By signing the consent form, a person agrees to participate in the study.More Info: To participate in a study is voluntary. Before agreeing to participate in a study, a person should know what the study procedures will be. A person can always withdraw from a study if they decide that they no longer want to participate. Before doing so, the participant should have a conversation with the study team.Other Info to Think About When Joining a Study: Your doctor may ask you if you want to participate in a study. Additionally, during the consent process, a person from the study team will make sure you want to participate in the study before joining. You could ask about the benefits and risks if you participate in the study. It will also be important for you to know what the study procedures are when you participate in this study.Related Terms: join, be a part of, volunteer", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Patient Reported Outcomes (PROs)", "definition": "Glossary Definition: The information that patients share about their own health or well-being to answer questions in a study.Use in Context: Patient Reported Outcomes are a way to hear directly from patients about their health or study experience.More Info: Measures to collect Patient Reported Outcomes (PROs) includes how a participant feels during the study, such as mood, sleepiness, amount of pain, and adverse events. Participants can explain how the disease or the study treatment is affecting their ability to do things like exercising, sleeping, going to work, etc. PROs might be collected with surveys, questionnaires, diaries, or interviews. PROs are important because they allow patients to report directly how they feel, and not as observed by the doctor, researcher, or someone else. PROs can often measure what is important to participants. Analyzing the data allows researchers to draw some conclusions about the outcome.Other Info to Think About When Joining a Study: A study you decide to participate in may involve collecting patient reported outcomes (PROs). This may be listed in the consent form as something you need to do if you enroll in a study. You may wish to ask how PROs will be collected because it could be from surveys, interviews, diary entries or another way not mentioned here. You may also want to clarify how much detail they want when you provide these answers. Most PROs are not reviewed in real time so participants should not expect to hear back from the study staff about what was entered.Related Terms: Patient Reported Outcome Measure (PROM)", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "peer review", "definition": "Glossary Definition: Evaluation by independent experts.Use in Context: Medical journal articles and grant applications often go through a peer review process.More Info: Peer review involves a critical assessment of the ethics, methods, conduct, analysis, and reporting of research by other experts in the field. Peer review is done by people who are independent and not involved in the research study conduct. A peer review process helps maintain rigor, independence, validity, standards and integrity of research studies. A peer review process asks \"Does the content we are reviewing meet the expected quality and standard?\"Other Info to Think About When Joining a Study: You could hear about scientific journal articles going through a \"peer review\" process before they can be published. Many scientific journals that report research results include a peer review step to make sure the information is shared publicly.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "periodically", "definition": "Glossary Definition: At regular or expected times.Use in Context: The study staff checks in with participants periodically to see how they are feeling.More Info: When something happens periodically, it usually means that it happens on a schedule and is expected.Other Info to Think About When Joining a Study: The word \"periodically\" could be used to describe how the study is monitored or how often some sort of event could happen. If something in the study materials is described as \"periodically,\" you may want to ask the study team what that timing will mean for you as a participant in the study.Related Terms: scheduled, regularly, repeatedly", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Pharmacodynamic (PD) study", "definition": "Glossary Definition: A study that measures the effects of a drug on the human body.Use in Context: During a pharmacodynamic study a participant will have their blood and other body fluids collected a few times over a few hours to see how the dose of the study treatment affects their body.More Info: A pharmacodynamic (PD) study is the study of the effects of the drug on the human body. A PD study helps researchers learn whether the study treatment is having the desired effect on the body, and how the dose of the drug affects the response. For example, a PD study could try to find out if a drug for cancer will attach to a cancer cell and lead to the cell's death.Other Info to Think About When Joining a Study: You might see the term \"pharmacodynamic study\", when researchers want to find out what effect the drug has on participants' bodies and how their bodies react. This is different from a pharmacokinetic study where the effect of the body on the drug is measured. Researchers use this information to design clinical trials, for example, what doses to give to participants. Because of this, pharmacodynamic studies are usually conducted early in the research process to help guide what is the best dosage for humans to take and to also look at safety in general. If you are considering participating in a pharmacodynamic study you can ask the researchers about what is already known about the drug, and how the study team will be monitoring the safety of the participants.Related Terms: Pharmacokinetic (PK) study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Pharmacokinetic (PK) study", "definition": "Glossary Definition: A study that measures what happens to a drug in a person\u2019s body over time.Use in Context: A pharmacokinetic study often enrolls healthy volunteers first before other participants.More Info: A pharmacokinetic study means that a participant will have a blood draw and possibly other body fluids taken a few times over a few hours to see how the study treatment was used by the body. The PK study is done to find out how a drug is absorbed, moves through, is broken down, and exits the body.Other Info to Think About When Joining a Study: If you enroll in a pharmacokinetic study a drug or medicine will be given to you and then blood samples will be taken several times over several hours to see how the study treatment was processed by your body. If you have any questions about the drug or medicine being tested or how long the pharmacokinetic study will take, you could discuss them with the study team.Related Terms: Pharmacodynamic (PD) studies", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacovigilance", "definition": "Glossary Definition: A process to detect, review, and make decisions about drug safety to protect patients.Use in Context: Scientific drug safety monitoring is called pharmacovigilance.More Info: Pharmacovigilance is the science of monitoring the effects of drugs and vaccines. It involves detecting, understanding, and preventing adverse events and determining whether observed events are caused by the drug or vaccine. Pharmacovigilance happens during and after a research study, and after a drug is approvedOther Info to Think About When Joining a Study: The word \"pharmacovigilance\" is sometimes used in conversations about the risk and safety monitoring of a drug. If you see this word and have any questions about how it is being used, you should ask the study team.Related Terms: drug safety", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase", "definition": "Glossary Definition: A step in the overall clinical research process to test a new drug, device, or treatment.Use in Context: Research is done in phases to make sure a study treatment is safe and then whether it works before it is approved.More Info: A phase is a step in the research process. Phases of research studies build on each other and each phase has a separate goal. Phase 1 studies are usually the first to enroll humans and test for safety. Phase 2 studies test if the drug, device or treatment works. Phase 3 studies compare the study treatment to the usual, standard treatment. Phase 4 studies continue to collect data after a study treatment is approved. These are sometimes called post-marketing studies.Other Info to Think About When Joining a Study: You may see the term \"phase\" when you are reading about clinical trials. Before you enroll in a clinical trial you may want to ask about what phase the study is in. You may also want to know more about the information the study team already has about the risks and benefits of the study treatment that is being tested.Related Terms: clinical research, clinical trial, preclinical study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pilot study", "definition": "Glossary Definition: A small study that is done to test a process before starting a larger study.Use in Context: A pilot study is a way to detect and fix problems in the study process or to test a specific idea.More Info: A pilot study enrolls a limited number of participants to discover the best ways to conduct a larger study.Other Info to Think About When Joining a Study: A \"pilot study\" may test whether an intervention works well enough to continue studying it. Other times, a pilot study could be testing how the study treatment works in the body or the safety and participant experience of a product. You may want to ask if other studies have been done and their results, and about the risks and safety of the study treatment.Related Terms: Proof of principle; Proof of concept; Exploratory; First-in-Human", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "placebo", "definition": "Glossary Definition: Something that looks like the treatment being studied, but doesn't contain any medicineUse in Context: Using a placebo in a research study keeps the participant and study doctor from knowing who is receiving the active treatment.More Info: A placebo is made to look, taste and smell like the active treatment being studied. Depending on the study, a placebo can also refer to a device or sham surgery. A placebo helps the researcher see whether the active study treatment really works. Using a placebo reduces bias. Using a placebo in a research study is accepted when the risk of not treating a condition is small or when there is no effective standard of care to compare to.Other Info to Think About When Joining a Study: When describing the plan of the study, the study team or consent form will say whether or not therea placebo is being used in the study. When a placebo is included in a study, the participants will usually be assigned the placebo through \"randomization.\" This means that whether or not you get the placebo will happen by chance, like flipping a coin. You should feel free to ask if there is a chance you could be taking a placebo in the study. You can also ask if you will find out if you are on the placebo at the end of the study. It may also be important for you to ask how they will notify your regular doctors if you are on the placebo or taking an active study treatment if there is a medical need to know.Related Terms: sham substance, sham surgery, control group, sugar pill", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "placebo-controlled study", "definition": "Glossary Definition: A study with two or more groups where one group is given a placebo.Use in Context: Placebo-controlled trials are done to show how the study treatment performs compared to those not receiving the study treatmentMore Info: A placebo-controlled study compares an active treatment to something that made to look, taste and smell like the active treatment. Using a placebo helps the researcher see whether the active study treatment really works. Placebo-controlled trials are usually only done when the risk of not offering an active treatment for a condition is small or when there is no effective standard of care to use as the comparison.Other Info to Think About When Joining a Study: You will see the term \"placebo-controlled study\" if the research is using a placebo as a control group. If you are considering joining a study that has a placebo, you can ask how the researchers decide who gets the placebo. You can also ask if the study team will tell you what you were taking at the end of the study. You can also ask how the researchers will notify your own doctor about what you are taking in the study if there is a medical reason to know.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "platform trial", "definition": "Glossary Definition: A research study that tests and compares two or more study treatments for a disease or condition, with study treatment groups being added or removed during the study period.Use in Context: A platform trial is an efficient way to compare many study treatments at the same time.More Info: A platform trial is a type of randomized controlled trial (RCT). It is sometimes called a Master Protocol. This is because a platform trial uses Master Protocol to test the different study treatments in the same way, using the same design. A platform trial is done to compare multiple treatments or interventions by comparing them against each other and a control. This is a way to do research more efficiently with fewer patients to find an answer. As a platform trial progresses, the research team may add new study treatments to compare and remove ones that are not working or have too many adverse events.Other Info to Think About When Joining a Study: You may hear about platform trials when you are learning about different types of study designs. If you are unsure about what it means for a research study to be a platform trial, you should ask a member of the study team to clarify any of your questions.Related Terms: master protocol, basket trial, umbrella trial", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "positive test result", "definition": "Glossary Definition: A test result that shows a person has what was tested for.Use in Context: A positive COVID test means that the person most likely has COVID.More Info: A positive test result for a disease, condition, genetic marker, or biomarker means that a person is likely to have or to have had the condition. A \"false positive\" means that the test incorrectly found someone to be positive when they are actually negative. Tests try to reduce the number of false positives.Other Info to Think About When Joining a Study: You may see the term \"positive test result\" in the context of study screening or a study procedure. You may want to ask if you will get the test result and if yes, how long it will take for the results to be ready. If you have any questions about the test result you should discuss with the study team.Related Terms: sensitivity, specificity, false positive", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "post-market surveillance", "definition": "Glossary Definition: Continuing to collect and analyze information about the risks and benefits of medicine and devices after they have been approved for patient use.Use in Context: Post-market surveillance means that the risks and benefits of medicines and devices are being reviewed after the product has been approved for use.More Info: Post-market surveillance happens after a drug or device has received approval by a goverment health authority. It can be done by safety reporting, regular monitoring, or a research study.Other Info to Think About When Joining a Study: All prescribed and marketed drugs and devices are monitored for safety, termed \"post-market surveillance.\" If you have questions about their safety, you should speak with a member of your usual healthcare team. You may also want to ask how you will be notified if any issues are identified in a drug or device you are using.Related Terms: pharmacovigilance, monitoring, phase 4 studies, post-marketing studies", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "post-trial access", "definition": "Glossary Definition: When participants can still receive a study treatment after their participation has ended.Use in Context: Participants should find out if they will have post-trial access to the study treatment.More Info: Post-trial access applies to drugs and devices. Whether and how participants will be able to receive a study treatment usually comes up when the treatment has not yet been approved/certified and there are few or no alternatives.Other Info to Think About When Joining a Study: You might see the term \"post-trial access\" while reading a research consent form. It could be helpful to know whether or not you will be able to still take the study treatment after your time in the study is over. If you are confused about what is being offered post-trial, be sure to ask the study team. If there is no mention of post-trial access, you should still ask the study team if there are plans to give you the investigational product after your participation in the study has ended.Related Terms: continued access", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "preclinical study", "definition": "Glossary Definition: A study to test a treatment in the lab or in animals before testing it in people.Use in Context: A preclinical study is done to make sure the study treatment is safe enough to give to people.More Info: If a study treatment has gone through preclinical studies, it means there was lab or animal testing before it was found to be safe enough to give to humans in a clinical trial.Other Info to Think About When Joining a Study: Most studies involving investigational products are designed based on data from other studies, including preclinical studies. If you are thinking about joining a clinical trial, you can ask about the results of the preclinical studies and why the research team thinks this investigational product can be used in humans.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "prevalence", "definition": "Glossary Definition: Number of known cases or events in a group.Use in Context: The prevalence tells us how many people in a population have a specific disease or condition.More Info: Measuring the prevalence of a health issue is a way to understand how many people are affected in a given time period. It measures how common the condition or disease is, regardless of when the person developed the condition or disease. For example, in 2021, the prevalence of diabetes in the US was 11.6% of the population, and 14.7% of all adults (i.e., people aged 18 and older).Other Info to Think About When Joining a Study: The term \"prevalence\" is used to describe how many people are known to have a particular disease or condition. You may want to ask the study team what the prevalence of adverse events in past studies was.Related Terms: frequency, rate, see also incidence", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "primary endpoint", "definition": "Glossary Definition: A study measure that is used to answer the main research question.Use in Context: The primary endpoint is the main purpose of the study.More Info: A primary endpoint is how the main research question will be answered. A study is designed to assess the primary endpoint. A study may also have secondary endpoints.Other Info to Think About When Joining a Study: You may see the concept of the \"primary endpoint\" written about in the consent form or hear about it from the study team. Additionally, if you visit a research study registry (like www.clinicaltrials.gov) you may see studies describe primary and secondary endpoints. The primary endpoint is the main thing the study is measuring. If you are enrolling in a study and have any questions about what the main goal of the study is, please ask the study team. After a research study is done and publications are released, you may also read about different types of endpoints.Related Terms: primary aim, outcome, outcome measure", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "probability", "definition": "Glossary Definition: The likelihood or chance that something might happen.Use in Context: The informed consent process should include information about the probability of adverse events.More Info: Probability is also used to describe the likelihood of a risk factor or exposure leading to a condition or disease, for example, what the probability of developing lung cancer is after smoking cigarettes.Other Info to Think About When Joining a Study: You may see the term \"probability\" used to describe the chance that you will be assigned into one group or another in the study (randomization). You may also see this term when discussing how likely a risk or adverse event might happen. When you see this term, it might be helpful to ask what the probability means for you as a participant in the study or if you are taking a particular treatment. For example: What is the probability that you will get one study treatment over another? What is the probability of a particular risk happening to you?Related Terms: chance, odds, likelihood, possibility", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "procedures (for participants)", "definition": "Glossary Definition: The activities that participants will be asked to do during the research study.Use in Context: The procedures listed in the consent form include all of the activities that participants will do while they are in the study.More Info: Study procedures are all the ways that the researchers collect data and samples from participants. Common procedures include interviews, surveys, blood draws, X-rays and scans, and taking a study treatment. The procedures that impact participants will all be listed in the consent form (for example, study visits, blood draws, filling out questionnaires, etc). Other study procedures that the study team has to do are listed in the protocol (for example, data collection and entry).Other Info to Think About When Joining a Study: The consent form will list the \"procedures required for a study.\" The procedures describes how many visits there are and what study activities will happen at each visit. The study team should review these with you and answer any questions you have.Related Terms: schedule of assessments, schedule of activities", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "progression-free survival", "definition": "Glossary Definition: The length of time without a person's illness getting worse.Use in Context: Some studies look at progression-free survival to see whether a drug helps keep the disease from getting worse.More Info: Progression-free survival is often used to assess the treatment of diseases that are slow-growing and difficult to cure. Whether a disease is getting worse is measured via procedures such as scans, test results, biomarkers, self-report, etc.Other Info to Think About When Joining a Study: Depending on the kind of study you are considering or reading about, you may see or hear references to \"progression-free survival\" during the informed consent process or other informational study materials. \"Progression-free survival\" may be used to explain the purpose of a study or explain the reason for particular procedures and tests. For example, a study could be collecting data on how long a person lives without the illness getting worse. If you have any questions about what it means for a study to look at progression-free survival, you should ask the study team.Related Terms: disease-free survival", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "prospective study", "definition": "Glossary Definition: Research that uses new data collected from participants.Use in Context: Prospective studies actively collect new data from participants.More Info: A prospective study collects new data over time. For example, a lung cancer study might compare two treatments to see if one works better than the other to shrink a tumor.Other Info to Think About When Joining a Study: The word \"prospective\" is often used to describe the timing of when a study's data are being collected. A prospective study collects data moving forward. It can be helpful to confirm the schedule with the study team.Related Terms: forward-looking study, real time study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol", "definition": "Glossary Definition: A complete description of the research plan and procedures.Use in Context: The protocol is like a recipe to make sure the research study is done in the same way by all of the study team members.More Info: A protocol is shared among study team members and approved by an institutional review board (IRB) to ensure that the study procedures are conducted consistently. Participants do not usually get to review the complete protocol but its content will be discussed during the informed consent conversation and at study visits.Other Info to Think About When Joining a Study: You may learn about the term \"protocol\" from the study team or in the consent form. The protocol could be discussed when the study team talks about the instructions they have to to follow to run the study. Although the protocol is not always shared direvtly with participants, may the study protocol on trial registration sites like www.clinicaltrials.gov. Feel free to ask the study team any questions you have about the study protocol.Related Terms: study protocol, research protocol, consent form, informed consent", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "proxy", "definition": "Glossary Definition: A person who is legally allowed to make research decisions for someone else.Use in Context: A proxy has legal permission to choose whether someone who cannot give informed consent on their own should be in a study.More Info: A proxy can be a legal guardian or legally authorized representative (LAR). A proxy can make decisions based on the wishes or best interests of the potential participant. A proxy is permitted to sign a consent form on behalf of the study participant.Other Info to Think About When Joining a Study: You may see or hear the word \"proxy\" used in cases when participants who are legally not able to make research decisions for themselves are being recruited into a study. For example, a proxy might be needed in a situation where someone has a head injury or is so sick that that they are not able to talk or sign the consent form. If you are a proxy for someone else, feel free to ask the study team any questions you have about the research study.Related Terms: guardian, legally authorized representative", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pseudonymized", "definition": "Glossary Definition: Replace personal details with a code so that data are protected.Use in Context: To pseudonymize data means that all direct identifiers such as name, birthdate, or address have been replaced with a code.More Info: Researchers pseudonymize data to mask the identify of a specific participant. This also protects participants' personal information from anyone who does not have a research-related reason to know. When data are pseudonymized, identifiable information is replaced with a code to protect their identity. For example, a person's name might be changed to a code like 14252. In some cases, researchers keep the code linking back to the participant for returning results or seeking additional information, but they do not share that code.Other Info to Think About When Joining a Study: You may see the word \u201cpseudonymize\u201d used in the consent form to describe how data collected in the study will be protected. Researchers are required to make sure that no personally identifiable information is ever released outside of the study to people who should not have access. If you have any questions about how your data will be protected, please feel free to ask the study team.Related Terms: coded, anonymized", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "purpose", "definition": "Glossary Definition: What the study is testing.Use in Context: The purpose of research is to answer a scientific question.More Info: The consent form always includes a description of the purpose of the study. The purpose is also described in the protocol.Other Info to Think About When Joining a Study: If you are a proxy for someone else, you should consider what would be in their best interest and what they would do if they were able to make the decision on their own.Related Terms: study purpose, objective, aim, goal, rationale, hypothesis, intention", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Quality of Life (QOL)", "definition": "Glossary Definition: How someone feels and functions day to day.Use in Context: The goal of measuring participant Quality of Life is to understand how they feel and their mental, physical, and social well-being.More Info: Quality of Life (QOL) questions look at how someone feels about their life in the context of their culture and values, QOL is also measured in relation to their own goals, expectations, standards, and concerns. Quality of Life is often based on the person's ability to do or enjoy daily living activities. For example, if a person used to take daily walks but no longer is able to, this person's Quality of Life might be impacted negatively.Other Info to Think About When Joining a Study: The study team may collect information about your Quality of Life during the study. They may want to compare your Quality of Life before the study and your Quality of Life after you start the study treatment. Quality of Life may be something you write down yourself using study surveys. This information could also be collected through interviews. You could ask the study team to list out specific things that you may want to consider when thinking about your own Quality of Life.Related Terms: assessment of daily living, Patient Reported Outcome (PRO), Quality Adjusted Life Year (QALY)", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "questionnaire", "definition": "Glossary Definition: A list of questions for study participants to answer as part of the study.Use in Context: A questionnaire is one way researchers can collect data.More Info: A questionnaire could be used to find out if a person is eligible to take part in the study, to see how someone is feeling, or to measure the effects of an intervention. A questionnaire could be online or on paper.Other Info to Think About When Joining a Study: A questionnaire or multiple questionnaires may need to be completed over the course of your participation in the study. This may be something you do by yourself or someone on the research team may do it with you. As with any study procedure, you can ask what the purpose of the questionnaire is and if it has to be completed all at once.Related Terms: survey, assessment, data", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "randomization", "definition": "Glossary Definition: A way to use chance to place study participants into different study treatment groups.Use in Context: Study randomization is often done using a computer program to decide which group a participant is put into.More Info: Randomization helps make sure the study groups are similar so they can be compared against each other at the end of the study. This is a way to avoid bias. Every participant has a chance to be put into one of the study groups. No one can choose which group a participant is placed in, because it is done by a computer program.Other Info to Think About When Joining a Study: Randomization is a common way that is used for participants to be assigned to different treatment groups. You might see the term \"randomization\" in the consent form or other study materials. Randomization means that you can't chooses which study treatment you will get. The study treatment is chosen by chance, like pulling names out of a hat. If you are unsure, you should ask if randomization will happen in your study. You can also ask for more information about how the randomization will be completed.Related Terms: random assignment, randomize, randomly assigned, blinded, study arm, bias", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "randomized controlled trial", "definition": "Glossary Definition: Research that uses chance to assign participants into study groups.Use in Context: A randomized controlled trial is used to compare two or more groups.More Info: In a randomized controlled trial (RCT), the researchers use a computer program to randomly assign which study treatment each participant receives. The computer program sometimes also randomly chooses the order of the study treatment, depending on the study. The process of being randomized is sometimes described like \"flipping a coin\" or \"pulling name out of a hat.\" Randomization ensures that participants are put into different study groups fairly and without bias.Other Info to Think About When Joining a Study: A randomized controlled trial is considered one of the best study designs to find out how well a study treatment works against one or more comparison groups. If you are asked to participate in a randomized controlled trial, you may want to find out more about the different study groups, what the control group will be, and how participants will be randomized.Related Terms: randomization, control, control group, research bias", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "rationale", "definition": "Glossary Definition: The reason why a study, or something in a study, is being done.Use in Context: A well-planned research study includes a clear rationale for why the study is necessary and important.More Info: The study rationale explains why the study is important and why the study question must be answered. It can include background information, study details, and relevant justifications. A study without a strong rationale might not be worth doing.Other Info to Think About When Joining a Study: You might see the rationale for why a research study is done a certain way being described in the study protocol or consent form. It can be helpful to learn more about the rationale of the study before agreeing to participate. Feel free to ask the study team questions about the background of the study and why it is being conducted.Related Terms: reason, explanation, purpose", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Real World Data (RWD)", "definition": "Glossary Definition: Information from many different sources used for health research purposes.Use in Context: Real World Data comes from sources like medical records, insurance claims, pharmacies, and wearables such as smart phones or heart monitors set up for that purpose.More Info: Real World Data are routinely collected and not specifically for research. Some studies use Real World Data such as health information in electronic medical records or insurance claims to learn more about side effects of medicines.Other Info to Think About When Joining a Study: Some research studies use Real World Data. You may see the term \"Real World Data\" mentioned in a consent form or described in study results. If a study uses Real World Data, you can also ask how these data are collected and protected.Related Terms: data", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Real World Evidence (RWE)", "definition": "Glossary Definition: Findings from analyzing Real World Data.Use in Context: Real World Evidence comes from analyzing data that are collected from routine sources like medical records and health insurance claims.More Info: Real World Evidence is often used to understand how medicines work in the real world, not in a clinical trial. Real World Evidence uses routinely collected Real World Data to answer a study question. For example, Real World Evidence can show whether a drug is effective for a given population or subgroup of people based on the number of doctor's visits they need after taking the drug.Other Info to Think About When Joining a Study: You may see the term \"real world evidence\" in research results or study summaries, to describe how the data collected from \"real world\" sources prove a particular point or supports a certain conclusion. For example, data taken from insurance claims may provide evidence that one kind of treatment reduces hospital readmissions more than a different treatment.Related Terms: Real World Data (RWD)", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "registry (study)", "definition": "Glossary Definition: An organized list of research information.Use in Context: A clinical trial registry is a place to search for research studies.More Info: Organized lists of information are valuable to research so many types of registries exist. A medicine or research registry has many different types of information for different uses. One example is a clinical trial registry which can include information about research studies that are planned, enrolling, or completed. Some registries also include research results. A patient registry might be set up by a hospital or health system to allow their community members to express interest in volunteering for research so they can be contacted for participation when a new study is being offered. A disease registry, like a cancer registry, is a resource to hold specific information about people with a certain disease. Some disease registries allow those who are registered to indicate they are interested in research. Some disease registries just allow researchers to conduct research using the information in the registry.Other Info to Think About When Joining a Study: Before you consent to join a research-related registry, you may want to find out more about what information about you will be collected, how your information will be used, and how your privacy will be protected. There are also other types of registries too that don't include any of your personal information For example, some studies that are funded with money from the USA government are required to post information about the study and its results on a research registry called www.clinicaltrials.gov. You may see a reference to www.clinicaltrials.gov in the consent form if the study team plans to release the overall study results there.Related Terms: clinical trial registry, Patient registry, Participant registry, disease registry", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "reimburse", "definition": "Glossary Definition: Pay money back to participants for their out-of-pocket study costs.Use in Context: Some studies will reimburse for parking, transportation, and other costs of participation.More Info: Participants in research should find out whether the study team will reimburse any personal costs that might arise because of being in the study.Other Info to Think About When Joining a Study: When the study team is providing information about what will happen if you participate in the study, they may say if they will reimburse you. You can ask if the study team will reimburse you for out-of-pocket costs related to participating in the study. For example, if you have to pay for parking at the study site, you can ask if the study team pay you back for that cost. Find out what out-of-pocket costs will be reimbursed can be important when deciding whether or not to join a study.Related Terms: repay, compensate, refund, remunerate, to pay someone back", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "relative risk", "definition": "Glossary Definition: The chance of a harmful event happening in one study group compared with another.Use in Context: If a relative risk is 1 the chance of an adverse event happening is the same across study groups.More Info: For example, if a study finds that 20% of smokers develop lung cancer and 5% of non-smokers develop lung cancer, then we can calculate the relative risk of lung cancer in smokers versus non-smokers as: Relative Risk = 20%/ 5% = 4 Thus, in this example, smokers are 4 times more likely to develop lung cancer than non-smokers.Other Info to Think About When Joining a Study: You may see the term \"relative risk\" used in publications about the data and statistics of a research study. The results section of a publication will report the findings which will often include information about how many participants in one arm experienced a health event or problem versus particpants in a comparison group. In general, however, \"relative risk\" is a technical math term and will not usually be used in materials designed especially for patients and participants. If you see this word in a study document for a study you are considering, enrolled in, or completed, you can ask the researcher or study team any questions you might have.Related Terms: risk, absolute risk", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "repository (research)", "definition": "Glossary Definition: A collection of participant data and samples stored for future research.Use in Context: A research repository is a safe way for data and samples to be stored for future research studies.More Info: A research repository stores both data and samples that have been collected with the purpose of being used in the future. Like a database, a research repository has strict rules for protecting and accessing the data and samples that are stored in it.Other Info to Think About When Joining a Study: A research study may collect data and/or samples to store in a repository for future use. If data or samples will be stored for future use, the informed consent form will ask for your consent. You might want to ask the study team about your privacy is maintained, how the data and samples are protected, who can use them in the future, and for what purpose. It is unlikely you will be contacted in the future how they were used.Related Terms: database, data bank, biobank, collection of information, sample repository", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "results (study)", "definition": "Glossary Definition: Findings from the study.Use in Context: The final results of the study are only available after all data are analyzed.More Info: Study results are based on the data that were collected, analyzed, and interpreted in the study. An example of a study result is learning that yoga can decrease low back pain. Study participants can ask for the research results. Results can be shared in several ways: In a journal article, in a study summary for participants, or in other types of communication.Other Info to Think About When Joining a Study: The term \"results\" may appear in publications after the trial is completed and the study team has used the data collected to come out with their findings. You can ask if and how the study team will share results with you when the study ends. If they will share, you can ask if you will get your individual information or if it will be a summary of the overall findings. You can also ask if this information will be shared with your regular doctor. In general, because research studies can take a long time to complete, it may take a while for study results to be finalized and shared. Feel free to ask about when the study team thinks the final study results will be ready.Related Terms: outcome, conclusions, findings, data", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "retrospective study", "definition": "Glossary Definition: Research that uses already existing data.Use in Context: Retrospective studies use data that were collected in the past.More Info: A retrospective study looks at the historical data of participants. For example, a study of people with cancer might use existing medical records to learn more about possible causes and exposures. A retrospective study may also use stored specimens or tissue samples that were collected in the past.Other Info to Think About When Joining a Study: You may see the term \"retrospective study\" if you are asked to give informed consent for the study team will look through your past medical records. You may want to ask them about what information they will be obtaining about you and why, and how your privacy will be protected.Related Terms: backward-looking study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "risk-benefit ratio", "definition": "Glossary Definition: A comparison of the possible bad and potential good things that could happen if a participant joins a research study.Use in Context: It is important to discuss and understand the risk-benefit ratio of a research study before agreeing to participate.More Info: People look at the risk-benefit ratio in different ways. Some may be less willing to accept a risk. Others may decide that the possible benefits are greater than the risks. Feelings about a study's risk-benefit ratio can differ from person-to-person based on their own experiences, life situation, pre-existing conditions, and concerns. It can be helpful for someone who is thinking about joining a study to discuss the risk-benefit ratio with the study team, trusted friends, and family members.Other Info to Think About When Joining a Study: The term \"risk-benefit ratio\" is sometimes part of consent forms and consent discussions. It is a way to try to describe how the risks and benefits of the study compare. Thinking about the risk-benefit ratio can help you decide whether the study has enough potential benefits to outweigh the risks of being in the study. You can talk to the study team and other trusted people in your life to work through whether or not to join the study, based on the information that is known about the study treatment.Related Terms: risk benefit assessment, risk benefit profile, therapeutic index", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "risks of a research study", "definition": "Glossary Definition: The possible harms of being in a research study.Use in Context: Learning about the risks of a research study can help a person decide whether or not to join.More Info: The risks of a research study depend on the study and study procedures. Both the serious and more common risks are listed in the consent form. A potential participant should talk about the study risks with the study team and others before deciding whether to participate. Some risks may not be known when a person signs the consent form. The study team will keep the participant updated if important new risks are identified. Sometimes there are also risks to other people to consider so these should also be reviewed and understood. For example, if a study shares genetic information that could impact other family members. The chance of a risk happening is sometimes called \"absolute risk.\" The absolute risk is a number that shows how many people might have a specific event happen. In general, \"\"absolute risk\"\" is a technical math term and will not usually be used in materials designed especially for patients and participants. A related word is \"relative risk.\"Other Info to Think About When Joining a Study: You might see the term \u201crisks of the research study\u201d when the study team gives you a consent form to review and tells you about the study. They will explain the risks that you may experience if you join the study. Ask questions about any of the risks you don\u2019t understand before agreeing to take part in a study. Risk may involve harm to the body but it may also include things like risk of stigma if sensitive information that is collected during the study is accidentally shared or accessed by others without permission. To learn more about the risks of a research study, you can ask things like: \u2013 How much do the researchers know about the risks of the study treatment \u2013 especially if it is new or experimental? \u2013 Does the study treatment have FDA approval or oversight? \u2013What are the short- or long-term risks, discomforts, or unpleasant side effects? How likely are they to occur, and are any of them severe? -What are the researchers doing to decrease risks, discomforts, or unpleasant side effects? \u2013 Is there anything a participant could do to minimize their risks during the study?Related Terms: disadvantages, cons, harms, negative impacts, downsides, adverse effects, side effects", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sample size", "definition": "Glossary Definition: The number of participants in a study or study group.Use in Context: A study's sample size should ensure there will be enough participants enrolled to answer the study question.More Info: The sample size must be able to be reached so that the study question can be answered. A statistician helps to calculate the sample size to ensure it is large enough to answer the study question. Sample size is often reported as n = . For example, a study with 100 participants would have its sample size described at n=100.Other Info to Think About When Joining a Study: The study team may tell you about the sample size of the study. You may also read about the sample size of the study in the consent form. You may want to ask how many people have already enrolled in the study before you agree to join.Related Terms: population size, target population size, statistician, study population", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "schedule of assessments", "definition": "Glossary Definition: A chart that lists the study activities and when they will happen during a study.Use in Context: A schedule of assessments can help participants plan for their study visits.More Info: A schedule of assessments is like a calendar or timeline. The schedule of assessments shows a detailed overview of all the study activities that involve participants and when they will happen. Study activities can include blood draws, exams, questionnaires, and other medical tests.Other Info to Think About When Joining a Study: If you are thinking about joining a study,you may see a \"schedule of assessments\" in the consent form. Someone from the study team may also provide more details. The study team will want to know if you can make it to all the study visits and if you understand all the activities youhave to do while in the study. If the schedule seems confusing, it can be helpful to ask the study team to help answer any questions. Additionally, putting all the activities that you need to do to participate in a study (like study visits or surveys) onto your personal calendar can help you plan.Related Terms: schedule of activities, calendar, timetable, study schema", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "screening", "definition": "Glossary Definition: Tests and questions to find out if a person can join a study.Use in Context: Screening is done before a person joins the study to see if they meet the study requirements.More Info: Researchers review inclusion and exclusion criteria as part of the screening process to make sure the participants are eligible to join a study. Screening for research often includes an interview, reviewing a person's medical history, a physical examination, and laboratory tests to learn about the potential participant's health. There is also screening that occurs outside of research like having a yearly breast cancer screening and colonoscopies.Other Info to Think About When Joining a Study: \"Screening\" is a word that is commonly seen in consent forms. There may be some screening questions and medical tests you will complete to see if you meet the study eligibility criteria. You can ask what kind of screening the study team will have to do before you can join the study.Related Terms: eligibility criteria, inclusion criteria, exclusion criteria, assessment, study screening, screen failure, medical screening, health screening", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "secondary endpoint", "definition": "Glossary Definition: A measure used to answer other important questions in the study that are not the main research question.Use in Context: A secondary endpoint can provide more information about the effect of the study treatment.More Info: A secondary endpoint can help guide researchers to answer other questions related to the study treatment. A secondary endpoint can also be exploratory, for example, looking for information that might be useful for a future study.Other Info to Think About When Joining a Study: You may see the concept of the \"secondary endpoint\" written about in the consent form or hear about it from the study team. Additionally, if you visit www.clinicaltrials.gov you may see references to primary and secondary endpoints. Secondary endpoints are other aspects that the study is designed to measure. If you are unsure of what it means, please ask the study team for clarification. After the study is done and publications are released, you may also read about different types of endpoints. Some studies might only have a primary endpoint and you will not see anything about a secondary endpoint. This is normal.Related Terms: Secondary aim", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sensitivity (medical test)", "definition": "Glossary Definition: How well a medical test can accurately identify people who have a disease or trait.Use in Context: The sensitivity of a test refers to how well it detects a disease when the person actually has the disease.More Info: A medical test that has high sensitivity means it is very good at detecting a disease. If it has low sensitivity it means it is not very good at detecting a disease. Greater sensitivity leads to a more precise diagnosis. For example, a COVID test with high sensitivity means the test is able to detect the infection very well.Other Info to Think About When Joining a Study: In clinical research and medicine, the term \"sensitivity\" is used to describe how well a medical test works to find cases of an illness or condition. A test that works well to identify people with an illness or condition is said to be very sensitive. You can always ask the study team if you have any questions about the way the term \"sensitivity\" is being used in the study information.Related Terms: specificity, true positive, false negative, false positive", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sequential", "definition": "Glossary Definition: Happening in a specific order.Use in Context: Events that occur one after the other are sequential.More Info: Research studies have steps and procedures that must be followed in a specific, sequential order.Other Info to Think About When Joining a Study: The word \"sequential\" can be used to describe the order that study activities are conducted. If you have any questions about sequential study activities you can ask the study team to better understand.Related Terms: one after the other, consecutive, successive", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Serious Adverse Event (SAE)", "definition": "Glossary Definition: A health issue that happens during a study, and can lead to hospital care, lasting medical problems, life-threatening conditions, or death.Use in Context: A Serious Adverse Event in a study is usually something very concerning that was not expected.More Info: Serious Adverse Events (SAEs) are health problems that may result in death, an inpatient hospital stay or longer hospitalization, a life-threatening event, a disability happening, or a birth defect in a baby. An SAE may or may not be related to the study treatment. There are sometimes new SAEs that could occur that even the study team does not know about yet. The study staff will collect this information from participants to keep track and figure out if it needs to be included in future study informed consent forms. In contrast to a Serious Adverse Event, an \"adverse reaction\" is determined to be related to a study treatment.Other Info to Think About When Joining a Study: You may learn about potential Serious Adverse Events during the consent process if they are known. You could also learn about them during or after the research study if they are discovered later. When you are in a research study, it is important to contact the study team if you have any new health problems whether or not they are serious. This is important for your safety and allows the study team to also monitor the other study participants. You can ask about adverse events, and Serious Adverse Events, before joining or during a study.Related Terms: adverse event, adverse reaction, side effect, dangerous event, life-threatening event, unanticipated problem", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "side effect", "definition": "Glossary Definition: A health change that is not the intended effect of the treatment and usually considered a problem.Use in Context: A side effect is not the main effect of the treatment.More Info: Side effects are things that are known to be a possible effect of a treatment. For example, a side effect of taking aspirin is excess bleeding. Often times, a side effect is unwanted, but in some cases a side effect could be considereda good thing.Other Info to Think About When Joining a Study: Known side effects are listed in the consent form. A member of the study team may also tell you about possible side effects. Ask any questions about the side effects and how likely they are. You can also ask what you should do if you think you are getting a side effect and who you should tell.Related Terms: health effect, adverse reaction", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "single-blind study", "definition": "Glossary Definition: A study that is set up so that the study treatment each participant receives is not known by the participants but is known by the researchers.Use in Context: A participant in a single-blind study will not know which study group they are in, but the study doctor will.More Info: Some studies are single-blind because participants knowing which treatment they are getting can affect the results of the study, through a concept called bias. Bias can occur when participants know which study group they are in. Participants can ask to find out which study treatment they received after the study ends.Other Info to Think About When Joining a Study: The term \"single-blind study\" refers to how a study was designed. This means that the researcher will know what study treatment each participant received but the participant won't. You can always ask the researchers why the study is done as a single-blind study. You could also ask if and when you will find out what study treatment you were given.Related Terms: masked/masking, bias, double-blind study, randomization", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "specificity (medical test)", "definition": "Glossary Definition: How well a medical test can accurately identify people who do not have a disease or trait.Use in Context: The specificity of a test refers to how well it identifies when an illness is not present.More Info: A medical test that has high specificity means it is very good at detecting if a person does not have a disease. If it has low specificity it identifies people as having the disease when they actually do not. Greater specificity allows people who do not have a condition to be identified and screened out so resources can be put toward caring for people who do have the condition. For example, a COVID test with high specificity means the test correctly identifies when people don't have the infection.Other Info to Think About When Joining a Study: In clinical research and medicine, the term \"specificity\" is used to describe how well a medical test works to show people who do not have an illness or condition. A test that works well to rule out people who do not have an illness or condition is said to be very specific. You can always ask the study team if you have any questions about the way the term \"specificity\" is being used in the study information.Related Terms: sensitivity, false positive, true negative, false negative.", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sponsor", "definition": "Glossary Definition: The group that is in charge of, or pays for, a research study.Use in Context: The study sponsor is often the drug or device company that makes and studies the product.More Info: A sponsor in clinical research is a person or group that is responsible for the design, conduct, and oversight of a research study. There can be different types of sponsors. A sponsor can be a drug or device company, governmental agency, academic institution, person, group, or private organization. A \"Funding Sponsor\" is a person or group that pays for the research study but does not conduct the study. A \"Regulatory Sponsor\" is a person or group that has to report to regulators (like the FDA) about the specific drug or device being tested in a study and may be conducting the study. A \"Sponsor Investigator\" is a person who designs, conducts, reports the study. The person is generally an academic researcher who is responsible to the regulatory agencies.Other Info to Think About When Joining a Study: The term \"sponsor\" may be in the consent form or mentioned when the study team discusses who is running the study. The sponsor is the person or group who is responsible for how the study is conducted. The sponsor could be a drug company or a researcher. You can ask the study team who the sponsor is and if the sponsor of the study is the group that made the investigational product that will be used in the study. You may also ask if the investigators have any financial relationship with the sponsor outside of the study or have been paid by the sponsor for other services besides the study. In general, any financial relationships between researchers and companies should be described in the consent form and made clear to the study participants.Related Terms: funder, sponsor investigator, pharmaceutical company", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "standard of care", "definition": "Glossary Definition: The usual treatment given to patients for an illness.Use in Context: Some research studies compare the study treatment to the standard of care for a given condition.More Info: Depending on the health issue, there could be many types of standard of care that are used by health care providers. For example, there are different medications used to treat high blood pressure.Other Info to Think About When Joining a Study: The term \"standard of care\" may come up in the consent form where it may explain that the study is comparing a new study intervention with the existing standard of care. If you have any questions about the study treatment you are being given or the standard of care, you should feel free to ask the study team.Related Terms: standard therapy, standard treatment, usual care", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "statistically significant", "definition": "Glossary Definition: Results that are very unlikely to have occurred by chance.Use in Context: Study results are analyzed to find out if they are statistically significant.More Info: When a result is found to be statistically significant, it means that a study result probably did not happen by chance. It does not necessarily mean that the finding is clinically important. For example - a study could show a new medicine lowers blood pressure (statistically significant) but the side effects are too great to make it a useful treatment (not clinically meaningful). Similarly, a statistically significant result in a study may be different than a person's lived experience. For example, a study may show a statistically significant overall decrease in depression scores based on data collected from all participants in the study but an individual participant may still have feelings of depression.Other Info to Think About When Joining a Study: You might see the term \"statistically significant\" used in a research article when the authors discuss the results and statistics. The results section may also provide more information about what it means for the data to be statistically significant. You may also see this term in Plain Language Summaries of a study's results.Related Terms: clinically meaningful", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study design", "definition": "Glossary Definition: The way a study is set up to answer the study question.Use in Context: It is very important for researchers to use a study design that will answer the study questions.More Info: The study design determines how participants will be recruited and enrolled, whether participants will be randomized, what kinds of data will be collected, and how the data will be analyzed. There are many different types of study design.Other Info to Think About When Joining a Study: Researchers are careful about using the right study design to answer a specific question. You might learn about the study design from the study team or the consent form. You may be able to find more information about the study you are thinking about joining at www.clinicaltrials.gov. There may be a section called \"How is the study designed?\" If there is anything you don't understand about the study design you should ask the study team.Related Terms: design, single-blind study, double-blind study, randomization, observational study, clinical trial", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study feasibility", "definition": "Glossary Definition: How likely it is that a study can be completed.Use in Context: Research planning involves assessing study feasibility before starting to enroll participants.More Info: In research, study feasibility means that: -the study procedures are all necessary and not overly burdensome, -the number of proposed participants should be possible to enroll in the locations chosen, and -the study will have enough participants to answer the study question. Research teams should spend time looking at all the parts of the study to make sure they are \"doable.\" If a study has low feasibility, it is less likely to generate enough data to answer the study questions. Low study feasibility is not a failure of participants. Low feasibility reflects a failure of the study planning process.Other Info to Think About When Joining a Study: Study feasibility is about checking whether a study can be done as proposed. This is not the same as a \"feasibilty study\" which is a study that is done to find out if an intervention is possible Feel free to ask questions about how the research team planned the study and how they are ensuring the study will be able to answer the planned research questions.Related Terms: feasible, achievable, possible", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study intervention", "definition": "Glossary Definition: A treatment given to the participants in a studyUse in Context: If a research study includes an intervention, it means participants will test something to see its effects.More Info: A study intervention can be a treatment of a disease or condition or include ways to change behavior, attitudes, and maintain or improve health. For example, a study might test whether giving participants a step counter leads to weight loss.Other Info to Think About When Joining a Study: The study team or the consent form might mention the term \"study intervention.\" When you are learning about a clinical trial you should be given information about the study intervention which could be something you take (like a medicine) or do (like yoga) during the study to see if it has any effect. You can always ask for more information about the study intervention the research is testing. You may also want to ask about the background of the study intervention and any prior research that was done that led to the researchers starting a new study.Related Terms: study treatment, investigational product, investigational drug, investigational device", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study life cycle", "definition": "Glossary Definition: The steps of a research study from beginning to end.Use in Context: The study life cycle refers to all the steps that go into developing and running a research study.More Info: The steps of the study life cycle include: developing the study protocol and procedures, participant recruitment, screening, and consent, ongoing study procedures, follow-up, end of study procedures, and study close-out.Other Info to Think About When Joining a Study: You might hear about the \"study life cycle\" when discussing the research process with a study team member. The term \"study life cycle\" is often used to describe the overall plan for the study. As a participant, you are part of the study life cycle. If you join a study, your data are important for the study to be completed. Please feel free to ask the study team any questions you might have about the study.Related Terms: clinical trial life cycle", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study participant", "definition": "Glossary Definition: A person who joins a research study.Use in Context: A study participant volunteers to join research.More Info: If you are a study participant in a research study, your data will help answer the research question.Other Info to Think About When Joining a Study: A person who joins a study is called a \"study participant.\" The consent form will describe the study, and what study participants will be asked to do. Before you join a study you should understand what participating in the research will involve. Please ask any questions you have about being in the study.Related Terms: participant, subject, research participant, research subject, study subject, healthy volunteer, data, clinical trial, observational study", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study population", "definition": "Glossary Definition: All the participants in a study.Use in Context: A participant is a member of the study population.More Info: The study population is described in the consent form and the protocol.Other Info to Think About When Joining a Study: You may hear the term \"study population\" from the study team or read it in the consent form. There may be information about the number of individuals who are in the study population or what similarities the study population shares. The study population is also discussed in results and journal publications that describe what the study looked at. If you have any questions about the study population, you should feel free to ask.Related Terms: participant population, participant", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study statistician", "definition": "Glossary Definition: A person who uses math to help design a study and interpret the data.Use in Context: The study statistician reviews and analyzes the data, and reports the results back to the study team.More Info: Statisticians design studies to decrease bias and make the results as accurate as possible. Before a study begins, a statistician can help the study team calculate how many participants should be enrolled so the research question can be answered. A study statistician can analyze study data and present the results using numbers, charts, and graphs. Study statisticians are trained to figure out whether a result happened by chance or not.Other Info to Think About When Joining a Study: You may hear that a study statistician is part of the research study and will work with the data collected during the study. It is always fine to ask about who is working on the study and how your data are protected.Related Terms: data, results, analysis", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "substudy", "definition": "Glossary Definition: A study with a smaller group of participants already enrolled in the main study.Use in Context: A substudy is a study to answer questions related to the main study.More Info: A substudy asks a separate research question from the main study. It adds to the main study's objectives and uses all or a subset of participants or samples from the main study. A substudy is sometimes designed at the beginning of the main study. It is also possible that a substudy could happen later after some data have been analyzed.Other Info to Think About When Joining a Study: When you enroll in a study, there may be additional substudies you can choose to enroll in. For some substudies, you may need to go in for extra study visits or do some extra tests. The study team may want to collect more information from you to answer additional questions that the first study you enrolled in is not looking at. You will be consented for additional substudies. You may want to ask if there are substudies in the study you join. Additionally, you can ask if you have to join any substudies and ask for more information about how the substudy is different from the first study you are enrolling in. It could also be helpful to ask if you have to do additional tests or go in for more study visits if you join a substudy. This could help you decide if you have the time to join.Related Terms: basket trial, umbrella trial, cohort trial, master protocol", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "superiority trial", "definition": "Glossary Definition: A study to test if a study treatment works better than another treatment for the same condition.Use in Context: One example of a superiority trial would be to test whether a new medicine is better for treating asthma than an existing one.More Info: Superiority trials are done to find treatment options that work better than those that are already approved for a specific disease or condition.Other Info to Think About When Joining a Study: If you are thinking about joining a superiority trial, it will be a study that looks at whether one treatment works better than another. You should ask any questions you have about the treatments being tested before you consent.Related Terms: superiority study, confirmatory trial, equivalence trial, control; non-inferiority trial", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "synergistic effect", "definition": "Glossary Definition: When two or more things combined have a greater effect than when their individual effects are added together.Use in Context: A synergistic effect means that the combined effects of two products is stronger than what was expected.More Info: A combination of medications is synergistic if they work better together than if the individual component effects were added together. For example, Drug A decreases cancer growth by 10% and Drug B by 20% when each are used alone. One would predict that used together, cancer growth might be decreased by 30% (additive). If Drug (A + B) used together decreases cancer growth by 35% or more, the effect is considered \"synergistic.\"Other Info to Think About When Joining a Study: The term \"synergistic\" is sometimes used to describe how two things that are used together actually have a greater effect than just one of them used alone. It's like the two things work in synergy with each other to have more of an effect. You can ask the study team if you have any questions about the word \"synergistic\" is being used in study documents or conversations you are having.Related Terms: additive effect", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "tolerability", "definition": "Glossary Definition: How much a participant or group of participants can accept a study treatment's unwanted effects so they can keep taking it.Use in Context: Many drug studies look at the tolerability of the study treatment.More Info: Tolerability is looked at to find out how easy it is for treatment is to be delivered. For example, researchers can learn whether a pill is too big to be swallowed. Tolerability also tells us about the problems a treatment may cause, and how severe those problems are. If a person has to stop taking a study treatment because of related problems, then tolerability is low.Other Info to Think About When Joining a Study: Someone from the study team may ask you about the tolerability of the study treatment during follow-up visits or on questionnaires. You may want to clarify what they mean by \"tolerability.\" For some people, nausea might be tolerable while for others its not, so you should let the study staff know what you are feeling while taking the study treatment. You could also ask the study staff what you should do if you are having trouble taking the study treatment, or wish to stop taking it.Related Terms: safety, side effects, adverse effects", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "treatment effect", "definition": "Glossary Definition: How much a study treatment changes a condition, symptom, or function.Use in Context: Some drug studies collect information from participants to measure the treatment effect.More Info: The treatment effect shows how much the study intervention changes what the study is measuring when compared to not getting the study treatment or getting something different. For example, a study might measure whether, and by how much, blood pressure is lowered when participants take a new medicine.Other Info to Think About When Joining a Study: For studies that are looking at what a study treatment does, researchers often measure the treatment effect which is connected to the main purpose of the study and the types of data being collected. You should feel free to ask if you have any questions about how the treatment effect is being measured in the study.Related Terms: study effect, intervention effect, efficacy", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "umbrella trial", "definition": "Glossary Definition: A research study that tests and compares two or more study treatments for one disease or condition.Use in Context: In an umbrella trial, multiple study treatments are compared in a single disease or condition.More Info: An umbrella trial is a type of randomized controlled trial (RCT). It is also a type of Master Protocol Study. An umbrella trial uses a Master Protocol to compare different study treatments in the same way, using the same design, in a certain disease or condition. The difference between a basket and an umbrella trial is that a basket trial uses one drug to test against multiple diseases while an umbrella trial studies different drugs in a single disease.Other Info to Think About When Joining a Study: You may hear about umbrella trials when you are learning about different types of study designs. If you are unsure about what it means for a research study to be an umbrella trial, you should ask a member of the study team to clarify any of your questions.Related Terms: adaptive trial, master protocol, basket trial, platform trial", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "validate", "definition": "Glossary Definition: To confirm that a process or test works as planned, or results are true.Use in Context: In research, to validate something is to make sure that it works as expected.More Info: Anything used to measure research data should be valid and precise. Medical tests and surveys are validated through a process to make sure that they are measure what they intend to measure. Results can also be validated, which means they go through a process to see if the findings are true.Other Info to Think About When Joining a Study: You may hear study teams talking about validating the data and information they collect. This could include checking measurements they take from you and comparing them to expected outcomes to see if the equipment is working correctly.Related Terms: confirm, certify, substantiate, authenticate, replicate", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "voluntary participation", "definition": "Glossary Definition: Choosing to participate in research without feeling pressured.Use in Context: Joining a research study is voluntary.More Info: Research participation must be voluntary so no one feels pressured to join a study or that they must stay in a study. A participant can withdraw at any time.Other Info to Think About When Joining a Study: Before you join a study, the study team will want to be sure you know that participation is voluntary. The study team may tell you this verbally and it may also be in the consent form they give you to review. You should not feel forced into joining the study.Related Terms: free will, freely chosen, independent choice, autonomy", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "volunteer (to)", "definition": "Glossary Definition: To choose to join a study.Use in Context: A participant is someone who chooses to volunteer to join a research study.More Info: Participants might be healthy volunteers or patients, but everyone is free to make their own decision about participation. Even if they volunteer, they are free to leave the study at any time.Other Info to Think About When Joining a Study: Your doctor may ask if you want to volunteer for a study during a visit. You may also see this when reviewing a consent form, letting you know you do not have to join this study if you do not want to. You may want to ask your doctor about how to volunteer for a study. If you are considering volunteering for a study, you can ask about what the study procedures are and what will happen to participants in the study. You should not feel pressured to join a research study.Related Terms: agree, voluntary participation", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "wash-out", "definition": "Glossary Definition: A time before starting a study treatment when a person stops taking other medicines.Use in Context: A wash-out period removes certain current medications in the body so that they don't interfere with the study treatment.More Info: In research, a wash-out is a time when medication is stopped so it can be cleared from a person's body before the study intervention is given. A wash-out period makes sure that the medication and the study intervention don't interact and increases the study's safety. it also helps to show that effects observed in a study are from the study medication and not previous, unrelated medications. Not every study has a wash-out period. When a study has a wash-out period it is a pre-set time that depends on the protocol and what medicines the person is taking.Other Info to Think About When Joining a Study: Whether a research study requires a wash-out will be described in the consent form and the study team will discuss this with you. It will be important for you to ask if you will have to go through a wash-out period and how that might affect you if you have been taking medications regularly before starting the trial. It could be important to discuss this with your regular doctor to let them know you will be stopping your routine medications.Related Terms: discontinue, remove", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "withdraw", "definition": "Glossary Definition: To stop being a participant in a study.Use in Context: If a participant decides to withdraw from a study, they should discuss with the study team how to do so safely.More Info: A participant can decide to withdraw from a study or an investigator can decide to withdraw the participant, usually for safety reasons. Reasons to withdraw from the study should be discussed.Other Info to Think About When Joining a Study: There may be information about how to withdraw from the study that you hear about when going through the consent process. If you are thinking about stopping your participation in the study, ask the study team how to withdraw safely. You may also ask what may cause an investigator to withdraw you from the study. If there are incentives for being part of the study, you may not get all of them if you leave the study early.Related Terms: discontinue", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "X-ray", "definition": "Glossary Definition: A way of taking pictures of the inside of a person's body using X-ray radiation.Use in Context: An X-ray uses radiation to create images of bones, organs, and tissues.More Info: An X-ray creates pictures of the inside of a person's body to view bone fractures and dislocations, certain tumors and other growths, pneumonias, fluid collections, and other problems.Other Info to Think About When Joining a Study: You may hear the term \"X-ray\" when the study team is talking about what happens in the esearch study. The study team could also say they are looking at your X-rays to get data for the study. If you do need an X-ray for the study, you can get more information about what kind of X-ray the study team will need and what part of the body they will scan. You can also find out if the X-ray results from the research will be put into your medical records for your regular doctor to see.Related Terms: imaging study, CT scan, MRI", "sources": [ "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx" ], "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "A&WC", "definition": "Long Name/Description: adequate and well-controlled", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AABB", "definition": "Long Name/Description: American Association of Blood Banks", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AADA", "definition": "Long Name/Description: abbreviated antibiotic drug application (FDA) (used primarily for generics)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AAMC", "definition": "Long Name/Description: Association of American Medical Colleges", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AAPS", "definition": "Long Name/Description: American Association of Pharmaceutical Scientists", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AAS", "definition": "Long Name/Description: American Association for the Advancement of Science", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ABPI", "definition": "Long Name/Description: Association of the British Pharmaceutical Industry", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ACCP", "definition": "Long Name/Description: American College of Clinical Pharmacology", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ACDM", "definition": "Long Name/Description: Association for Clinical Data Management (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ACE", "definition": "Long Name/Description: angiotensin-converting enzyme", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ACIL", "definition": "Long Name/Description: American Council of Independent Laboratories. 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"Long Name/Description: Association of Official Analytical Chemists", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "APB", "definition": "Long Name/Description: Association Pharmaceutique Belge (Belgium)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "APhA", "definition": "Long Name/Description: American Pharmacists Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "API", "definition": "Long Name/Description: active pharmaceutical ingredient", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "APPI", "definition": "Long Name/Description: Academy of Pharmaceutical Physicians and Investigators", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": 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for Clinical Pharmacology and Therapeutics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ASP", "definition": "Long Name/Description: application service provider delivering a computer application via the www", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ASQ", "definition": "Long Name/Description: American Society for Quality (formerly American Society for Quality Control)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ATC", "definition": "Long Name/Description: Anatomic-Therapeutic-Chemical Coding dictionary", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AUC", "definition": "Long Name/Description: area under the curve (pharmacokinetics)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AxMP", "definition": "Long Name/Description: auxiliary medicinal product (ISO 11615:2017, 3.1.60)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BARQA", "definition": "Long Name/Description: British Association of Research Quality Assurance", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BCE", "definition": "Long Name/Description: beneficial clinical event", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BDPA", "definition": "Long Name/Description: Bureau of Drug Policy and Administration (China)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BEST", "definition": "Long Name/Description: Biologics Effectiveness and Safety System (US FDA, CBER); Biomarkers, EndpointS, and other Tools (Taxonomy Resource, US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BEUC", "definition": "Long Name/Description: European Bureau of Consumer Unions", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BfArM", "definition": "Long Name/Description: Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BGA", "definition": "Long Name/Description: Bundesgesundheitsamt (Federal health office; former German public health agency)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BGVV", "definition": "Long Name/Description: Bundesinstitut f\u00fcr gesundheitlichen Verbraucherschutz und Veterin\u00e4rmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BID", "definition": "Long Name/Description: bis in die (twice a day)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BIO", "definition": "Long Name/Description: Biotechnology Innovation Organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BIRA", "definition": "Long Name/Description: British Institute of Regulatory Affairs", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BLA", "definition": "Long Name/Description: biologics license application (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BrAP", "definition": "Long Name/Description: British Association of Pharmaceutical Physicians", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BRIDG", "definition": "Long Name/Description: Biomedical Research Integrated Domain Group", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "BSA", "definition": "Long Name/Description: body surface area", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "C3C", "definition": "Long Name/Description: China CDISC Coordinating Committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CA", "definition": "Long Name/Description: Competent Authority (EU)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "caBIG", "definition": "Long Name/Description: cancer biomedical informatics grid", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "caCORE", "definition": "Long Name/Description: cancer common ontologic resource environment", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "caDSR", "definition": "Long Name/Description: cancer data standards registry and repository. A toolset maintained by NCI.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CAS", "definition": "Long Name/Description: Chemical Abstracts Service", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CBER", "definition": "Long Name/Description: Center for Biologics Evaluation and Research (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CBIIT", "definition": "Long Name/Description: Center for Biomedical Informatics and Information Technology (NCI)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CCPPRB", "definition": "Long Name/Description: Comit\u00e9 Consultative pour la Protection des Personnes dans les Recherches Biom\u00e9dicales", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CCRA", "definition": "Long Name/Description: certified clinical research associate", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CCRC", "definition": "Long Name/Description: certified clinical research coordinator", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CCRP", "definition": "Long Name/Description: certified clinical research professional", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CCSI", "definition": "Long Name/Description: company core safety information", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDA", "definition": "Long Name/Description: clinical document architecture (HL7)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDASH", "definition": "Long Name/Description: Clinical Data Acquisition Standards Harmonization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDC", "definition": "Long Name/Description: Centers for Disease Control and Prevention", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDE", "definition": "Long Name/Description: common data element", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDER", "definition": "Long Name/Description: Center for Drug Evaluation and Research (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDISC", "definition": "Long Name/Description: Clinical Data Interchange Standards Consortium", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDM", "definition": "Long Name/Description: clinical data management", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDMS", "definition": "Long Name/Description: clinical data management system", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDRH", "definition": "Long Name/Description: Center for Devices and Radiological Health (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CEN", "definition": "Long Name/Description: Comit\u00e9 Europ\u00e9en de Normalisation (European Committee for Standardization)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CEU", "definition": "Long Name/Description: continuing education unit", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CF", "definition": "Long Name/Description: consent form", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CFR", "definition": "Long Name/Description: Code of Federal Regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cGMP", "definition": "Long Name/Description: current good manufacturing practices", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CHI", "definition": "Long Name/Description: consolidated health informatics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CHR", "definition": "Long Name/Description: Committee on Human Research", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CIC", "definition": "Long Name/Description: clinical imaging center", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CIOMS", "definition": "Long Name/Description: Council for International Organizations of Medical Sciences", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CIP", "definition": "Long Name/Description: certified IRB professional", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CIS", "definition": "Long Name/Description: Commonwealth of Independent States", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CLIA", "definition": "Long Name/Description: clinical laboratory improvement amendments", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ClinRO", "definition": "Long Name/Description: clinician-reported outcome", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Cmax", "definition": "Long Name/Description: concentration maximum", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CMC", "definition": "Long Name/Description: chemistry, manufacturing, and control", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CME", "definition": "Long Name/Description: continuing medical education", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CMS", "definition": "Long Name/Description: Centers for Medicare & Medicaid Services (formerly Healthcare Financing Administration); 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See also MedDRA.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "COU", "definition": "Long Name/Description: context of use", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "COVID-19", "definition": "Long Name/Description: Coronavirus disease 2019", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CPHS", "definition": "Long Name/Description: Committee for the Protection of Human Subjects", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CPMP", "definition": "Long Name/Description: Committee for Proprietary Medicinal Products (EU)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CPSC", "definition": "Long Name/Description: Consumer Product Safety Commission (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CR", "definition": "Long Name/Description: Complete Response (in oncology)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRA", "definition": "Long Name/Description: clinical research associate", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRADA", "definition": "Long Name/Description: Cooperative Research And Development Agreement (with US Government entities such as FDA or NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRB", "definition": "Long Name/Description: case record book; central review board", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRC", "definition": "Long Name/Description: clinical research coordinator", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRF", "definition": "Long Name/Description: case report form; case record form", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRIX", "definition": "Long Name/Description: clinical research information exchange", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRO", "definition": "Long Name/Description: contract research organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRT", "definition": "Long Name/Description: case report tabulation", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CSDD", "definition": "Long Name/Description: Center for the Study of Drug Development (Tufts)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CSF", "definition": "Long Name/Description: cerebrospinal fluid; collaborative standards forum (CDISC); colony stimulating factor", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CSM", "definition": "Long Name/Description: Committee on Safety of Medicines (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CSO", "definition": "Long Name/Description: Consumer Safety Officer (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CSR", "definition": "Long Name/Description: clinical study report", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CSU", "definition": "Long Name/Description: clinical supply unit", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CSUICI", "definition": "Long Name/Description: Computerized Systems Used In Clinical Investigations (replaced CSUCT). NOTE: usually pronounced \u201cseesweecy.\u201d", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CT", "definition": "Long Name/Description: clinical trial; computerized tomography; controlled terminology", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTA", "definition": "Long Name/Description: clinical trial agreement", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTC", "definition": "Long Name/Description: clinical trial certificate (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTCAE", "definition": "Long Name/Description: Common Terminology Criterion for Adverse Events", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTD", "definition": "Long Name/Description: common technical document", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTEP", "definition": "Long Name/Description: Cancer Therapy Evaluation Program", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTM", "definition": "Long Name/Description: clinical trial material", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTX", "definition": "Long Name/Description: clinical trial exemption (MCA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CUI", "definition": "Long Name/Description: common unique identifier", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CV", "definition": "Long Name/Description: curriculum vitae", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CVM", "definition": "Long Name/Description: Center for Veterinary Medicine (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DAWN", "definition": "Long Name/Description: Drug Abuse Warning Network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DCGI", "definition": "Long Name/Description: Drugs Controller General of India (Indian regulatory authority)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DD", "definition": "Long Name/Description: Department of Drugs (Swedish regulatory agency)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DDF", "definition": "Long Name/Description: data definition file", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DDI", "definition": "Long Name/Description: drug\u2013drug interaction", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DDT", "definition": "Long Name/Description: drug development tool (FDA-NIH BEST Resource)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DEA", "definition": "Long Name/Description: Drug Enforcement Administration (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DEN", "definition": "Long Name/Description: drug experience network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DES", "definition": "Long Name/Description: data encryption standard", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DESI", "definition": "Long Name/Description: Drug Efficacy Study Implementation notice (FDA) (to evaluate drugs in use before 1962)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DGPharMed", "definition": "Long Name/Description: Deutsche Gesellschaft f\u00fcr Pharmazeutische Medizin (German Society of Pharmaceutical Medicine, formerly F\u00c4PI)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DHHS", "definition": "Long Name/Description: Department of Health and Human Services (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DHTML", "definition": "Long Name/Description: dynamic HTML (IT)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DIA", "definition": "Long Name/Description: Drug Information Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DIBD", "definition": "Long Name/Description: development international birth date", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DICOM", "definition": "Long Name/Description: Digital Imaging and Communications in Medicine", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DIMs", "definition": "Long Name/Description: domain information models", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DITA", "definition": "Long Name/Description: Darwin Information Typing Architecture", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DLT", "definition": "Long Name/Description: dose-limiting toxicity", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DMB", "definition": "Long Name/Description: Data Management Biomedical (France)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DNA", "definition": "Long Name/Description: deoxyribonucleic acid", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DPC-PTR", "definition": "Long Name/Description: Drug Price Competition and Patent Term Restoration Act of 1984 (also 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"term": "DSMC", "definition": "Long Name/Description: Data and Safety Monitoring Committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DSNP", "definition": "Long Name/Description: Development of Standardized Nomenclature Project (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DST", "definition": "Long Name/Description: daylight saving time", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DSUR", "definition": "Long Name/Description: development safety update report (ICH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DTC", "definition": "Long Name/Description: direct-to-consumer (drug advertising)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DTD", "definition": "Long Name/Description: document type definition coordinating committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "E3C", "definition": "Long Name/Description: European CDISC coordinating committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EAB", "definition": "Long Name/Description: ethical advisory board", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EC", "definition": "Long Name/Description: European Commission; European Community (in documents older than the mid-1980s); ethics committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EC50", "definition": "Long Name/Description: half maximal effective concentration", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ECG", "definition": "Long Name/Description: electrocardiogram; European CDISC group", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ECJ", "definition": "Long Name/Description: European Court of Justice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eCOA", "definition": "Long Name/Description: electronic clinical outcome assessment", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ECOG", "definition": "Long Name/Description: Eastern Cooperative Oncology Group (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ECPHIN", "definition": "Long Name/Description: European Community Pharmaceutical Information Network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eCRF", "definition": "Long Name/Description: electronic case report form", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ECRIN", "definition": "Long Name/Description: European Clinical Research Infrastructures Network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eCTD", "definition": "Long Name/Description: electronic common technical document", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EDC", "definition": "Long Name/Description: electronic data capture/collection", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EDI", "definition": "Long Name/Description: electronic data interchange", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eDMS", "definition": "Long Name/Description: electronic data management system", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EDR", "definition": "Long Name/Description: electronic document room", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eDT", "definition": "Long Name/Description: electronic data transfer", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EEC", "definition": "Long Name/Description: European Economic Community, now EU; some regulatory documents still have EEC document numbers.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EFGCP", "definition": "Long Name/Description: European Forum for Good Clinical Practice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EFPIA", "definition": "Long Name/Description: European Federation of Pharmaceutical Industries and Associations", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EFTA", "definition": "Long Name/Description: European Free Trade Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eHR", "definition": "Long Name/Description: electronic health record", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EIR", "definition": "Long Name/Description: establishment inspection report (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ELA", "definition": "Long Name/Description: establishment license application (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EMA", "definition": "Long Name/Description: European Medicines Agency", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EMEA", "definition": "Long Name/Description: European Medicines Evaluation Agency (Predecessor to the EMA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EMWA", "definition": "Long Name/Description: European Medical Writers Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EOP2A", "definition": "Long Name/Description: end-of-phase 2A", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EORTC", "definition": "Long Name/Description: European Organization for Research and Treatment of Cancer", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EP", "definition": "Long Name/Description: European Parliament", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EPAR", "definition": "Long Name/Description: European Public Assessment Report", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EPO", "definition": "Long Name/Description: European Patent Office; erythropoietin", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EPRG", "definition": "Long Name/Description: European Pharmacovigilance Research Group", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ePRO", "definition": "Long Name/Description: electronic patient-reported outcome", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ER", "definition": "Long Name/Description: essential requirements (EMA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ERSR", "definition": "Long Name/Description: electronic regulatory submissions and review (FDA\u2019s e-Submissions processing group)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eRX", "definition": "Long Name/Description: electronic prescribing", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eSDI", "definition": "Long Name/Description: electronic source data interchange", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ESG", "definition": "Long Name/Description: electronic submission gateway (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eSR", "definition": "Long Name/Description: electronic source record. See eSource.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ESRA", "definition": "Long Name/Description: European Society of Regulatory Affairs", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eSRF", "definition": "Long Name/Description: electronic source report form", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ESTRI", "definition": "Long Name/Description: Electronic Standards for the Transfer of Regulatory Information (ICH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EU", "definition": "Long Name/Description: European Union", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EU CTR", "definition": "Long Name/Description: Clinical trials - Regulation EU No 536/2014", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EUA", "definition": "Long Name/Description: emergency use authorization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EUDRA", "definition": "Long Name/Description: European Union Drug Regulatory Authorities", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EudraCT", "definition": "Long Name/Description: European Union clinical trials database", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EVS", "definition": "Long Name/Description: Enterprise Vocabulary Services (National Cancer Institute)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EWG", "definition": "Long Name/Description: expert working group", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FAERS", "definition": "Long Name/Description: FDA adverse event reporting system", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FAQ", "definition": "Long Name/Description: frequently asked questions", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Farmindustria", "definition": "Long Name/Description: The Association of Italian Pharmaceutical Manufacturers", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FD&C Act", "definition": "Long Name/Description: Food, Drug, and Cosmetic Act (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FDA", "definition": "Long Name/Description: Food and Drug Administration (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FDAA", "definition": "Long Name/Description: Food and Drug Administration Amendment Act", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FDAMA", "definition": "Long Name/Description: FDA Modernization Act (pronounced fedahma)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FDLI", "definition": "Long Name/Description: Food and Drug Law Institute", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FFPM", "definition": "Long Name/Description: Fellow of the Faculty of Pharmaceutical Medicine (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FHIR", "definition": "Long Name/Description: fast healthcare interoperability resources (an HL7 resource)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FIPS", "definition": "Long Name/Description: federal information processing standards", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FISMA", "definition": "Long Name/Description: Federal Information Security Management Act", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FRCP", "definition": "Long Name/Description: Fellow of the Royal College of Physicians", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FTC", "definition": "Long Name/Description: Federal Trade Commission (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FTP", "definition": "Long Name/Description: file transfer protocol", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "FWA", "definition": "Long Name/Description: federalwide assurance", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GBP", "definition": "Long Name/Description: good business practice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Gbps", "definition": "Long Name/Description: gigabits per second (billions of bits per second in data transmission) NOTE: GBps stands for gigabytes per second (an 8 fold difference).", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GCP", "definition": "Long Name/Description: good clinical practice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GCRP", "definition": "Long Name/Description: good clinical research practice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GDPR", "definition": "Long Name/Description: General Data Protection Regulation", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GLP", "definition": "Long Name/Description: good laboratory practice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GMP", "definition": "Long Name/Description: good manufacturing practice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GMT", "definition": "Long Name/Description: Greenwich Mean Time. Compare to UTC. See also UMT and UT.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GP", "definition": "Long Name/Description: general practitioner", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GPMS", "definition": "Long Name/Description: good postmarketing surveillance practice (Japan)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GPT", "definition": "Long Name/Description: Generative, Pretrained, Transformer", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GPVP", "definition": "Long Name/Description: good pharmacovigilance practice", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GRAS", "definition": "Long Name/Description: generally regarded as safe", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GRP", "definition": "Long Name/Description: good review practice (CDER)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "GXP", "definition": "Long Name/Description: Good (X) Practices", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HA", "definition": "Long Name/Description: health authority (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HD", "definition": "Long Name/Description: high dose; high definition", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HEOR", "definition": "Long Name/Description: health economics and outcomes research", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HEX", "definition": "Long Name/Description: human experimentation committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HHS", "definition": "Long Name/Description: Department of Health and Human Services (US, also called DHHS)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HIE", "definition": "Long Name/Description: Health Information Exchange", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HIMA", "definition": "Long Name/Description: Health Industry Manufacturers Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HIMSS", "definition": "Long Name/Description: Healthcare Information and Management Systems Society (pronounced hymns)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HIPA", "definition": "Long Name/Description: Health Insurance Portability and Accountability Act", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HIT", "definition": "Long Name/Description: health information technology", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HITSP", "definition": "Long Name/Description: Health Information Technology Standards Panel (pronounced hitspee)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HL7", "definition": "Long Name/Description: Health Level 7", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HPB", "definition": "Long Name/Description: Health Protection Branch (Laboratory Centre for Disease Control (Canada); has been superseded by Health Canada)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HPLC", "definition": "Long Name/Description: high performance liquid chromatography", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HRQoL", "definition": "Long Name/Description: health-related quality of life", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HSRC", "definition": "Long Name/Description: human subjects review committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HTML", "definition": "Long Name/Description: hypertext markup language", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HTTP", "definition": "Long Name/Description: hypertext transfer protocol", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "I3C", "definition": "Long Name/Description: India CDISC Coordinating Committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IB", "definition": "Long Name/Description: investigator\u2019s brochure", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IBD", "definition": "Long Name/Description: international birth date", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IC", "definition": "Long Name/Description: informed consent", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICD", "definition": "Long Name/Description: International Classification of Diseases NOTE: Followed by a number indicating the version. E.g., ICD9 and ICD10. See also MedDRA.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICF", "definition": "Long Name/Description: informed consent form", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICG", "definition": "Long Name/Description: India CDISC Group", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICH", "definition": "Long Name/Description: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICMJE", "definition": "Long Name/Description: International Committee of Medical Journal Editors", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICR", "definition": "Long Name/Description: Institute of Clinical Research (formerly Association for Clinical Research in the Pharmaceutical Industry, ACRPI, UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICSR", "definition": "Long Name/Description: individual case safety report", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICTH", "definition": "Long Name/Description: International Committee on Thrombosis and Haemostasis", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICTRP", "definition": "Long Name/Description: International Clinical Trials Registry Platform (WHO)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ICU", "definition": "Long Name/Description: intensive care unit", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IDE", "definition": "Long Name/Description: investigational device exemption application to CDRH to get permission for investigational device testing in clinical trials.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IEC", "definition": "Long Name/Description: independent ethics committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IEEEE", "definition": "Long Name/Description: Institute of Electrical and Electronic Engineers, Inc.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IFAP", "definition": "Long Name/Description: International Federation of Associations of Pharmaceutical Physicians", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IFPMA", "definition": "Long Name/Description: International Federation of Pharmaceutical Manufacturers and Associations", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IG", "definition": "Long Name/Description: Inspector General (HHS)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IHE", "definition": "Long Name/Description: Integrating the Healthcare Enterprise", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IHI", "definition": "Long Name/Description: Institute for Healthcare Improvement", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IKS", "definition": "Long Name/Description: Interkantonale Kontrollstelle f\u00fcr Heilmittel (Switzerland)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IMI", "definition": "Long Name/Description: Innovative Medicines Initiative (European Commission)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IMP", "definition": "Long Name/Description: investigational medicinal product", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IMPD", "definition": "Long Name/Description: Investigational Medicinal Product Dossier (EUDRA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IND", "definition": "Long Name/Description: investigational new drug application (FDA). See also TIND.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "INN", "definition": "Long Name/Description: international nonproprietary name", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IOM", "definition": "Long Name/Description: Institute of Medicine (National Academy of Science, US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IRB", "definition": "Long Name/Description: institutional review board; independent review board", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IRD", "definition": "Long Name/Description: international registration document", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IS", "definition": "Long Name/Description: International System of Units (may also be referred to as Syst\u00e8me Internationale).", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ISCB", "definition": "Long Name/Description: International Society for Clinical Biostatistics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ISDN", "definition": "Long Name/Description: integrated services digital network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ISO", "definition": "Long Name/Description: International Organization for Standardization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ISOQOL", "definition": "Long Name/Description: International Society for Quality of Life Research", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ISP", "definition": "Long Name/Description: internet service provider", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IT", "definition": "Long Name/Description: information technology", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ITU-T", "definition": "Long Name/Description: International Telecommunication Union\u2014Telecommunication Standardization Sector", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IUPAC", "definition": "Long Name/Description: International Union of Pure and Applied Chemistry", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IVD", "definition": "Long Name/Description: in vitro diagnostics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "IVRS", "definition": "Long Name/Description: interactive voice response system", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "J3C", "definition": "Long Name/Description: Japan CDISC Coordinating Committee", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "JCAHO", "definition": "Long Name/Description: Joint Commission on Accreditation of Healthcare Organizations", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "JCG", "definition": "Long Name/Description: Japan CDISC Group", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "JMA", "definition": "Long Name/Description: Japan Medical Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "JPMA", "definition": "Long Name/Description: Japan Pharmaceutical Manufacturers Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "KASA", "definition": "Long Name/Description: Knowledge-aided Assessment & Structured Application (a new FDA pharmaceutical quality assessment system)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Kbps", "definition": "Long Name/Description: kilobits per second (thousands of bits per second in data transmission) NOTE: KBps stands for kilobytes per second (an 8 fold difference)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "KFDA", "definition": "Long Name/Description: Korean Food and Drug Administration", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LAB", "definition": "Long Name/Description: laboratory data model (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LAN", "definition": "Long Name/Description: local area network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LAR", "definition": "Long Name/Description: Legally Authorized Representative", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LIF", "definition": "Long Name/Description: Swedish Pharmaceutical Industry Association", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LKP", "definition": "Long Name/Description: Leiter der Klinischen Pr\u00fcfung", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LLM", "definition": "Long Name/Description: Large Language Model", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LOA", "definition": "Long Name/Description: letter of agreement", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LOINC", "definition": "Long Name/Description: logical observations, identifiers, names, and codes", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "LREC", "definition": "Long Name/Description: local research ethics committee (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MA", "definition": "Long Name/Description: marketing authorization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MAA", "definition": "Long Name/Description: marketing authorisation application (EMA, EU)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MAH", "definition": "Long Name/Description: Marketing Authorisation Holder (EU)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MaPP", "definition": "Long Name/Description: Manual of Policies and Procedures (CDER)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Mbps", "definition": "Long Name/Description: megabits per second, (millions of bits per second in data transmission) NOTE: MBps stands for megabytes per second (an 8 fold difference).", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MCM", "definition": "Long Name/Description: medical countermeasure", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MDR", "definition": "Long Name/Description: medical device reporting", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MDSAP", "definition": "Long Name/Description: medical device single audit program", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MedDRA", "definition": "Long Name/Description: Medical Dictionary for Regulatory Activities", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MedID", "definition": "Long Name/Description: medicinal product identifier", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MEDLARS", "definition": "Long Name/Description: medical literature analysis and retrieval system", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MEFA", "definition": "Long Name/Description: Association of the Danish Pharmaceutical Industry", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MEP", "definition": "Long Name/Description: member of the European Parliament", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MHLW", "definition": "Long Name/Description: Ministry of Health, Labor and Welfare (Japan)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MHRA", "definition": "Long Name/Description: Medicines and Healthcare products Regulatory Agency (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MIAME", "definition": "Long Name/Description: minimum information about a microarray experiment (standard for microarray data)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MIC50", "definition": "Long Name/Description: minimum inhibitory concentration required to inhibit the growth of 50% of organisms", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MOA", "definition": "Long Name/Description: mechanism of action", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MOH", "definition": "Long Name/Description: Ministry of Health (UK, Canada, others)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MOPH", "definition": "Long Name/Description: Ministry of Public Health (Thailand, Yemen, others)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MOU", "definition": "Long Name/Description: memorandum of understanding", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MPDT", "definition": "Long Name/Description: medical product development tool (FDA-NIH BEST Resource)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MPID", "definition": "Long Name/Description: medicinal product identifier", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MPR", "definition": "Long Name/Description: Medical Products Agency (Swedish Regulatory Agency)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MR", "definition": "Long Name/Description: Medical Representative (Japan)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MRA", "definition": "Long Name/Description: medical research associate", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MREC", "definition": "Long Name/Description: Multicentre Research Ethics Committee (UK). See also Ethics Committee in the Glossary.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MRI", "definition": "Long Name/Description: magnetic resonance imaging", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MRP", "definition": "Long Name/Description: mutual recognition procedure", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MTD", "definition": "Long Name/Description: maximum tolerated dose", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MVP", "definition": "Long Name/Description: master validation plan", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NABR", "definition": "Long Name/Description: National Association for Biomedical Research", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NAF", "definition": "Long Name/Description: notice of adverse findings (FDA postaudit letter)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NAI", "definition": "Long Name/Description: no action indicated (most favorable FDA postinspection classification)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NAS", "definition": "Long Name/Description: new active substance (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NAS\u2013NRC", "definition": "Long Name/Description: National Academy of Sciences\u2013National Research Council (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NBAC", "definition": "Long Name/Description: National Bioethics Advisory Commission (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NCA", "definition": "Long Name/Description: national competent authority", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NCE", "definition": "Long Name/Description: New Chemical Entity", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NCI", "definition": "Long Name/Description: National Cancer Institute (National Institutes of Health, USA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NCICB", "definition": "Long Name/Description: National Cancer Institute Center for Bioinformatics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NEFARMA", "definition": "Long Name/Description: Dutch Association of the Innovative Pharmaceutical Industry", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NEI", "definition": "Long Name/Description: National Eye Institute (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NEST", "definition": "Long Name/Description: National Evaluation System for Health Technology (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NGO", "definition": "Long Name/Description: nongovernmental organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NHI", "definition": "Long Name/Description: National Health Insurance (Japan)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NHIN", "definition": "Long Name/Description: National Health Information Network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NHLBI", "definition": "Long Name/Description: National Heart, Lung, and Blood Institute (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NHS", "definition": "Long Name/Description: National Health Service (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIA", "definition": "Long Name/Description: National Institute on Aging (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIAAA", "definition": "Long Name/Description: National Institute on Alcohol Abuse and Alcoholism (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIAID", "definition": "Long Name/Description: National Institute of Allergies and Infectious Diseases (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIAMS", "definition": "Long Name/Description: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIBIB", "definition": "Long Name/Description: National Institute of Biomedical Imaging and Bioengineering", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NICHD", "definition": "Long Name/Description: National Institute of Child Health and Human Development (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIDA", "definition": "Long Name/Description: National Institute on Drug Abuse (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIDCD", "definition": "Long Name/Description: National Institute on Deafness and Other Communication Disorders (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIDCR", "definition": "Long Name/Description: National Institute of Dental and Craniofacial Research (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIDDK", "definition": "Long Name/Description: National Institute of Diabetes and Digestive and Kidney Diseases (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIEHS", "definition": "Long Name/Description: National Institute of Environmental Health Sciences (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIGMS", "definition": "Long Name/Description: National Institute of General Medical Sciences (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIH", "definition": "Long Name/Description: National Institutes of Health (DHHS)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIMH", "definition": "Long Name/Description: National Institute of Mental Health (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIMP", "definition": "Long Name/Description: Non-Investigational Medicinal Product", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NINDS", "definition": "Long Name/Description: National Institute of Neurological Disorders & Stroke (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NINR", "definition": "Long Name/Description: National Institute of Nursing Research (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIRB", "definition": "Long Name/Description: Non-Institutional Review Board. See NRB. See also Ethics Committee, Independent.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NIST", "definition": "Long Name/Description: National Institute of Standards and Technology", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NLM", "definition": "Long Name/Description: National Library of Medicine (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NME", "definition": "Long Name/Description: New Molecular Entity", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NOAEL", "definition": "Long Name/Description: no observed adverse effect level (IUPAC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NOEL", "definition": "Long Name/Description: no observable effect level", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NRB", "definition": "Long Name/Description: noninstitutional review board, also known as an independent review board. See also Ethics Committee in the Glossary, NIRB.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NSCLC", "definition": "Long Name/Description: non-small cell lung carcinoma", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NTP", "definition": "Long Name/Description: National Toxicology Program", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OAI", "definition": "Long Name/Description: official action indicated (serious FDA postinspection classification)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OASIS", "definition": "Long Name/Description: open accessible space information system", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ObsRO", "definition": "Long Name/Description: observer-reported outcome", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ODAC", "definition": "Long Name/Description: Oncologic Drugs Advisory Committee (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ODE", "definition": "Long Name/Description: Office of Drug Evaluation", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ODM", "definition": "Long Name/Description: operational data model (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OGD", "definition": "Long Name/Description: Office of Generic Drugs (formerly DBG, CDER)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OGE", "definition": "Long Name/Description: Office of Government Ethics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OHITA", "definition": "Long Name/Description: Office of Health Information Technology Adoption (ONCHIT)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OHRP", "definition": "Long Name/Description: Office for Human Research Protections (pronounced O-harp)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OIG", "definition": "Long Name/Description: Office of the Inspector General", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OIQ", "definition": "Long Name/Description: outcome instrument qualification", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OIS", "definition": "Long Name/Description: Office of Interoperability and Standards", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OJEC", "definition": "Long Name/Description: Official Journal of the European Communities", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OMB", "definition": "Long Name/Description: Office of Management and Budget (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ONCHIT", "definition": "Long Name/Description: Office of the National Coordinator for Health Information Technology (HIMSS)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OPR", "definition": "Long Name/Description: Office of Policy and Research", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OPRR", "definition": "Long Name/Description: Office for Protection from Research Risks (predecessor to OHRP)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OSHA", "definition": "Long Name/Description: Occupational Safety & Health Administration (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "OTC", "definition": "Long Name/Description: over-the-counter (refers to nonprescription drugs)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PAB", "definition": "Long Name/Description: Pharmaceutical Affairs Bureau (Japan)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PADER/PAER", "definition": "Long Name/Description: periodic adverse drug experience report", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PAHO", "definition": "Long Name/Description: Pan American Health Organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PBRER", "definition": "Long Name/Description: periodic benefit-risk evaluation report", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PCC", "definition": "Long Name/Description: poison control center", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PD", "definition": "Long Name/Description: Progressive Disease (in oncology)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PDF", "definition": "Long Name/Description: portable document format", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PDQ", "definition": "Long Name/Description: Physicians\u2019 Data Query (NCI-sponsored cancer trial registry)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PDR", "definition": "Long Name/Description: Physicians\u2019 Desk Reference", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PDUFA", "definition": "Long Name/Description: Prescription Drug User Fee Act (1992, US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PDUFA IV", "definition": "Long Name/Description: Prescription Drug User Fee Act (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PEM", "definition": "Long Name/Description: prescription event monitoring", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PerfO", "definition": "Long Name/Description: performance outcome", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PFT", "definition": "Long Name/Description: pulmonary function test", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PGT", "definition": "Long Name/Description: pharmacogenetics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PGX", "definition": "Long Name/Description: pharmacogenomics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PHE", "definition": "Long Name/Description: public health emergency", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PHI", "definition": "Long Name/Description: protected health information", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PhPID", "definition": "Long Name/Description: pharmaceutical product identifier", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PhRMA", "definition": "Long Name/Description: Pharmaceutical Research and Manufacturers of America", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PHS", "definition": "Long Name/Description: Public Health Service (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PI", "definition": "Long Name/Description: principal investigator", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PII", "definition": "Long Name/Description: personally identifiable information", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PIM", "definition": "Long Name/Description: product information management", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PK", "definition": "Long Name/Description: pharmacokinetics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PKI", "definition": "Long Name/Description: public key infrastructure", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PLA", "definition": "Long Name/Description: product license application (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PLSP", "definition": "Long Name/Description: plain language summary of publications", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pm", "definition": "Long Name/Description: post meridian, evening (12 noon thru 23:59:59)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PMA", "definition": "Long Name/Description: premarket approval application (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PMDA", "definition": "Long Name/Description: Pharmaceutical and Medical Devices Agency and Medical Devices Agency (Japanese regulatory authority)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PMS", "definition": "Long Name/Description: postmarketing surveillance", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PO", "definition": "Long Name/Description: per os (by mouth)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PPD", "definition": "Long Name/Description: protected personal data", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PPI", "definition": "Long Name/Description: Patient Package Insert; Personally Protected Information", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PPO", "definition": "Long Name/Description: preferred provider organization; policy and procedure order", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PR", "definition": "Long Name/Description: Partial Response (in oncology)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PRIM&R", "definition": "Long Name/Description: Public Responsibility in Medicine and Research (Boston, MA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PRM", "definition": "Long Name/Description: protocol reference model", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PRO", "definition": "Long Name/Description: patient-reported outcome", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PROG", "definition": "Long Name/Description: Peer-Review Oversight Group (NIH)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PROMIS", "definition": "Long Name/Description: patient reported outcomes measurement information systems", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PSUR", "definition": "Long Name/Description: periodic safety update report", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PTC", "definition": "Long Name/Description: points to consider", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PV", "definition": "Long Name/Description: pharmacovigilance", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QA", "definition": "Long Name/Description: quality assurance", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QAU", "definition": "Long Name/Description: quality assurance unit", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QC", "definition": "Long Name/Description: quality control", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QD", "definition": "Long Name/Description: quaque die (once a day)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QID", "definition": "Long Name/Description: quater in die (four times a day)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QL", "definition": "Long Name/Description: quality of life", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QOL", "definition": "Long Name/Description: quality of life (also QoL)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "QRS", "definition": "Long Name/Description: questionnaires, ratings and scales", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "R&D", "definition": "Long Name/Description: research and development", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RADAR", "definition": "Long Name/Description: risk assessment of drugs\u2013analysis and response", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RAPS", "definition": "Long Name/Description: Regulatory Affairs Professionals Society", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RBM", "definition": "Long Name/Description: risk based monitoring", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RCRIM", "definition": "Long Name/Description: Regulated Clinical Research Information Management", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RCT", "definition": "Long Name/Description: randomized controlled trial; randomized clinical trial", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RDE", "definition": "Long Name/Description: remote data entry", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RDF", "definition": "Long Name/Description: resource description framework", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RDRC", "definition": "Long Name/Description: Radioactive Drug Research Committee (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "REB", "definition": "Long Name/Description: research ethics board (Canada)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RECIST", "definition": "Long Name/Description: Response Evaluation Criteria in Solid Tumors", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "REMS", "definition": "Long Name/Description: Risk Evaluation and Mitigation Strategy", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RFD", "definition": "Long Name/Description: retrieve form for data capture", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RFP", "definition": "Long Name/Description: request for proposal", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RHIO", "definition": "Long Name/Description: Regional Health Information Organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RIM", "definition": "Long Name/Description: reference information model (HL7)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RKI", "definition": "Long Name/Description: Robert-Koch-Institut, Bundesinstitut f\u00fcr Infektionskrankheiten und nich\u00fcbertragbare Krankheiten (Federal Institute for Infectious and Noncommunicable Diseases, Germany)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RL", "definition": "Long Name/Description: Regulatory Letter (FDA\u2014postaudit letter)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RMAT", "definition": "Long Name/Description: Regenerative Medicine Advanced Therapy", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RMP", "definition": "Long Name/Description: risk management plan", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RMS", "definition": "Long Name/Description: reference member state", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RMT", "definition": "Long Name/Description: Regenerative Medicine Therapy", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RNA", "definition": "Long Name/Description: ribonucleic acid", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ROA", "definition": "Long Name/Description: route of administration", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RPS", "definition": "Long Name/Description: Regulated Product Submission (HL7 RCRIM)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RR", "definition": "Long Name/Description: relative risk", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RSI", "definition": "Long Name/Description: reference safety information", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RWD", "definition": "Long Name/Description: Real-World Data", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RWE", "definition": "Long Name/Description: Real-World Evidence", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SACHRP", "definition": "Long Name/Description: Secretary\u2019s Advisory Committee on Human Protection. See also OHRP.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SADR", "definition": "Long Name/Description: suspected adverse drug reaction (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SAE", "definition": "Long Name/Description: serious adverse event", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SAFE", "definition": "Long Name/Description: secure access for everyone", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SaMD", "definition": "Long Name/Description: software as a medical device", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SARS-CoV-2", "definition": "Long Name/Description: Severe Acute Respiratory Syndrome Coronavirus-2 (novel coronavirus causing COVID-19 disease)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SAS", "definition": "Long Name/Description: statistical analysis system", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SATCM", "definition": "Long Name/Description: State Administration of Traditional Chinese Medicine (China)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SBA", "definition": "Long Name/Description: summary basis of approval", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SC", "definition": "Long Name/Description: study coordinator", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SCDM", "definition": "Long Name/Description: Society for Clinical Data Management", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SCT", "definition": "Long Name/Description: Society for Clinical Trials", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SD", "definition": "Long Name/Description: Stable Disease (in oncology)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDA", "definition": "Long Name/Description: State Drug Administration (China)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDM", "definition": "Long Name/Description: submission data model (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDO", "definition": "Long Name/Description: Standards Development Organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDS", "definition": "Long Name/Description: submission data standards (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDSP", "definition": "Long Name/Description: Study Data Standardization Plan", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDTM", "definition": "Long Name/Description: study data tabulation model (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDTMIG", "definition": "Long Name/Description: study data tabulation model implementation guide", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SDV", "definition": "Long Name/Description: source document verification; source data verification", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SE", "definition": "Long Name/Description: standard error (statistics)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SEA", "definition": "Long Name/Description: Single European Act of 1987", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SEER", "definition": "Long Name/Description: Surveillance, Epidemiology, and End Results program (NCI)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SEND", "definition": "Long Name/Description: standard for the exchange of nonclinical data", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SFDA", "definition": "Long Name/Description: State Food and Drug Administration (Chinese regulatory authority)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SGML", "definition": "Long Name/Description: standard generalized markup language", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SHARE", "definition": "Long Name/Description: shared health and research electronic library (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SIG", "definition": "Long Name/Description: Special Interest Group (HL7)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SLA", "definition": "Long Name/Description: service level agreement", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SMART", "definition": "Long Name/Description: submission management and review tracking (FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SME", "definition": "Long Name/Description: significant medical event", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SMO", "definition": "Long Name/Description: site management organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SmPC", "definition": "Long Name/Description: summary of product characteristics. See also SPC.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SNDA", "definition": "Long Name/Description: supplemental new drug application", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SNIP", "definition": "Long Name/Description: Syndicat National de l\u2019Industrie Pharmaceutique (France)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SNOMED", "definition": "Long Name/Description: Systematized Nomenclature of Medicine", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SoA", "definition": "Long Name/Description: schedule of activities", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SOAP", "definition": "Long Name/Description: simple object access protocol (a W3C XML initiative)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SOC", "definition": "Long Name/Description: System Organ Class (MedDRA); standard of care", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SoCRA", "definition": "Long Name/Description: Society of Clinical Research Associates", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SOP", "definition": "Long Name/Description: standard operating procedure", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SPAC", "definition": "Long Name/Description: State Pharmaceutical Administration of China", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SPC", "definition": "Long Name/Description: summary of product characteristics. See also SmPC.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SPIRIT", "definition": "Long Name/Description: Standard Protocol Items for Randomized Trials (CONSORT for protocols)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SPL", "definition": "Long Name/Description: Structured Product Labeling (HL7, FDA)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SPM", "definition": "Long Name/Description: Society of Pharmaceutical Medicine (UK)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SQA", "definition": "Long Name/Description: Society of Quality Assurance", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SQAP", "definition": "Long Name/Description: systems quality assurance plan", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SSC", "definition": "Long Name/Description: study site coordinator", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SSCT", "definition": "Long Name/Description: Swedish Society for Clinical Trials", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SSFA", "definition": "Long Name/Description: Societ\u00e0 di Scienze Farmacologiche Applicate (Italy)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "STF", "definition": "Long Name/Description: study tagging file", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "STT", "definition": "Long Name/Description: short term test", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SUAE", "definition": "Long Name/Description: serious unexpected adverse event", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SUD", "definition": "Long Name/Description: sudden unexpected death", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SUSAR", "definition": "Long Name/Description: suspected unexpected serious adverse reaction", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SWOG", "definition": "Long Name/Description: Southwest Oncology Group (US)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TAC", "definition": "Long Name/Description: technical advisory committee (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TC", "definition": "Long Name/Description: technical committee (HL7)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TCC", "definition": "Long Name/Description: technical coordinating committee (CDISC)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TCP/IP", "definition": "Long Name/Description: transmission control protocol/internet protocol", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TermID", "definition": "Long Name/Description: controlled vocabulary term identifier", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TESS", "definition": "Long Name/Description: treatment-emergent signs and symptoms", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TGA", "definition": "Long Name/Description: Therapeutic Goods Administration (Australian regulatory authority)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TIND", "definition": "Long Name/Description: treatment IND. See also IND.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TK", "definition": "Long Name/Description: toxicokinetics", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Tmax", "definition": "Long Name/Description: time to maximum plasma concentration; time to maximum effect (drugs)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "TMO", "definition": "Long Name/Description: trial management organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "UAT", "definition": "Long Name/Description: User Acceptance Testing", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "UCUM", "definition": "Long Name/Description: Unified Code for Units of Measure", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "UMT", "definition": "Long Name/Description: universal mean time (also known as Greenwich Mean Time and Universal Time). Compare to UTC.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "URL", "definition": "Long Name/Description: uniform resource locator", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "USAN", "definition": "Long Name/Description: United States adopted name", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "USC", "definition": "Long Name/Description: United States Code (book of laws)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "USDA", "definition": "Long Name/Description: US Department of Agriculture", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "USP", "definition": "Long Name/Description: United States Pharmacopeia", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "UST", "definition": "Long Name/Description: user site testing", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "UT", "definition": "Long Name/Description: universal time (also known as Greenwich Mean Time and Universal Mean Time). Compare to UTC.", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "UTC", "definition": "Long Name/Description: coordinated universal time", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "UUID", "definition": "Long Name/Description: universally unique identifier", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "VA", "definition": "Long Name/Description: Veterans Administration (officially, U.S. Department of Veterans Affairs)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "VAERS", "definition": "Long Name/Description: Vaccine Adverse Event Reporting System", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "VAI", "definition": "Long Name/Description: voluntary action indicated (FDA postaudit inspection classification)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "VCDE", "definition": "Long Name/Description: vocabularies and common data elements (caBIG)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "VGDS", "definition": "Long Name/Description: voluntary genomic data submission", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "VPN", "definition": "Long Name/Description: virtual private network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "W3C", "definition": "Long Name/Description: World Wide Web Consortium", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WAN", "definition": "Long Name/Description: wide area network", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WHO", "definition": "Long Name/Description: World Health Organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WHOART", "definition": "Long Name/Description: World Health Organization adverse reaction terminology", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WHODRUG/WHO-DRL", "definition": "Long Name/Description: World Health Organization drug reference list", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WL", "definition": "Long Name/Description: warning letter (most serious FDA postaudit letter)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WOCBP", "definition": "Long Name/Description: woman of childbearing potential", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WR", "definition": "Long Name/Description: written request", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WRAIR", "definition": "Long Name/Description: Walter Reed Army Institute of Research (DoD)", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WTO", "definition": "Long Name/Description: World Trade Organization", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "WWW", "definition": "Long Name/Description: world wide web", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "XML", "definition": "Long Name/Description: extensible markup language", "sources": [ "Abbreviations.xlsx" ], "source": "Abbreviations.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDISC Glossary", "definition": "CDISC Definition: The terminology of the Clinical Data Interchange Standards Consortium (CDISC) glossary.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "510(k)", "definition": "CDISC Definition: 510(k). Premarket Notification (PMN) required for certain medical devices. See http://www.fda.gov/cdrh/510khome.html.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "abbreviation", "definition": "CDISC Definition: A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. NOTE: An abbreviation is NOT pronounced as a word, but each letter is read in sequence (e.g., NIH). Compare to acronym.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "absorption", "definition": "CDISC Definition: The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes. See also ADME (pharmacokinetics).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "accelerated approval", "definition": "CDISC Definition: Regulatory mechanism by which new drugs meant to treat serious life-threatening diseases and that provide meaningful therapeutic benefit to patients over existing treatments can be approved rapidly. [after FDA, Guidance for Industry Expedited Programs for Serious Conditions - Drugs and Biologics; after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource https://www.ncbi.nlm.nih.gov/books/NBK338448/]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "accrual", "definition": "CDISC Definition: The accumulation or increase in the number of study subject enrolled over time. NOTE: Accrual is often conflated with enrollment but there is a semantic distinction in that accrual represents the rate of subject enrollment. [After Schroen AT, Petroni GR, Wang H, Thielen MJ, Gray R, Benedetti J, Wang XF, Sargent DJ, Wickerham DL, Cronin W, Djulbegovic B, Slingluff CL Jr. Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups. Clin Cancer Res. 2012 Jan 1;18(1):256-62.] See also target enrollment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "acronym", "definition": "CDISC Definition: A word formed from the beginning letters (e.g., ANSI) or a combination of syllables and letters (e.g., MedDRA) of a name or phrase. NOTE: An acronym is usually pronounced as a word, not by speaking each letter individually. Compare to abbreviation", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "action letter", "definition": "CDISC Definition: An official communication from FDA to an NDA sponsor announcing an agency decision. See also approval letter, approvable letter, not-approvable letter.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "activation (EDC)", "definition": "CDISC Definition: Enabling an eClinical trial system to capture data; usually used for EDC systems.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "active ingredient dose", "definition": "CDISC Definition: The amount of a single active substance administered in a single dose.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "active ingredient", "definition": "CDISC Definition: Any component of a drug product intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. [After 21 CFR 210.3(b)(7)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "active substance", "definition": "CDISC Definition: Substance responsible for the activity of the medicine. NOTE: The protocol may define the active substance in terms of the Anatomical Therapeutic Chemical (ATC) code (level 3-5). [EMA Glossary of regulatory terms; EU Reg 536/2014] See also international nonproprietary name (INN), generic name.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adaptive design", "definition": "CDISC Definition: A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. [Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry, FDA] See also master protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "additive effect", "definition": "CDISC Definition: An interaction between bioactive compounds or drugs that is deemed to be equal to the sum of the individual components. NOTE: The terms additivity, synergism, and antagonism should be used with care, unless the specific pharmacological pathways or mechanisms of action of the investigated drugs are known. [After Calzetta L, Koziol-White C. Pharmacological interactions: Synergism, or not synergism, that is the question. Curr Res Pharmacol Drug Discov. 2021 Aug 11;2:100046.] See also synergistic effect, antagonistic effect, drug interaction.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adequate and well-controlled studies", "definition": "CDISC Definition: Studies used to support drug marketing authorization and intended to provide substantial evidence of effectiveness required by law to support a conclusion that a drug is effective. NOTE: For additional information see COA glossary of terms. [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. 21 CFR 314.126]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adherence", "definition": "CDISC Definition: The act of abiding by a stated treatment plan or protocol. [NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adjuvant therapy", "definition": "CDISC Definition: Therapy administered to augment or stimulate other treatment modalities or to minimize or prevent disease recurrence subsequent to the main treatment. [After NCI Thesaurus] See also neoadjuvant therapy, treatment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "administrable dosage form", "definition": "CDISC Definition: Pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out. [After ISO 11615 Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated medicinal product information, Second edition 2017-10] See also route of administration, administration (substance).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "administration (substance)", "definition": "CDISC Definition: The act of introducing a substance into or onto the body. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also route of administration, administrable dosage form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "admission criteria", "definition": "CDISC Definition: Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study. See also inclusion criteria, exclusion criteria.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adverse drug reaction (ADR)", "definition": "CDISC Definition: Any noxious and unintended response associated with the use of a drug in humans. NOTE: 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility. 3. FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, \"whether or not considered to be drug-related.\" CDISC recognizes that current usage incorporates the concept of causality. [WHO Technical Report 498(1972); ICH E2A]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adverse event (AE)", "definition": "CDISC Definition: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. an adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A] See also serious adverse event, serious adverse experience.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adverse event of special interest", "definition": "CDISC Definition: An event (serious or non-serious) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. [ICH E19; ICH E2F]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "adverse reaction", "definition": "CDISC Definition: A response to a medicinal product, devices, or procedures, which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. In the context of drug development, the term is used as a synonym of adverse drug reaction. (After ICH E2A)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AEGIS (ADROIT Electronically Generated Information Service)", "definition": "CDISC Definition: A subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency ADROIT (Adverse Drug Reaction On-line Information Tracking) database.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AHIC (American Health Information Community)", "definition": "CDISC Definition: A US government-charted commission providing input and recommendations to HHS on how to make health records digital and interoperable, and assure the privacy and security of those records (HITSP).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "AI prompt", "definition": "CDISC Definition: Natural language inputs; a request made by the user to the AI tool. NOTE: It can be a question, code syntax, or any combination of text and code. Depending upon the prompt, the tool returns the response. [After \"What is an AI Prompt?\", GeeksforGeeks, 15 April 2025, https://www.geeksforgeeks.org/what-is-an-ai-prompt/] See also Generative AI (GenAI).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ALCOA", "definition": "CDISC Definition: Acronym for a number of attributes or dimensions that are considered of universal importance for data integrity of source data and the records that hold those data. These include that the data and records be: A-Attributable (to both subject and to any actor on a record); L-Legible (available for human review, possible to read electronically if an encoded eRecord); C-Contemporaneous (timing of data collection with respect to the time the observation is made: the more promptly an observation is recorded, the better the quality.); O-Original (the first suitably accurate and reliable recording of data for the intended purpose); A-Accurate (free from error especially as the result of care; an accurate diagnosis conforming exactly to truth or to a standard). NOTE: ALCOA stemmed from FDA's Dr. Stan Woollen's talks in the early 90's on earmarks for the quality of records and has become a widespread acronym reflecting best practices for clarity and usability of data. [From EMA Reflection Paper on eSOURCE in effect since 2010] See also: Data Quality and the Origin of ALCOA. See also: Six Primary Dimensions for Data Quality Assessment. See also ALCOA+, ALCOA++, data integrity, data quality.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ALCOA+", "definition": "CDISC Definition: Acronym for a number of attributes or dimensions included in ALCOA, plus the following: Complete, Consistent, Enduring, and Available when needed. NOTE: ALCOA+ is a recent way to summarily refer to the attributes or dimensions of data integrity.) [After EMA Reflection Paper on eSOURCE in effect since 2010. After WHO Annex V, Guidance on Good Data and Record Management Practices] See also ALCOA, ALCOA++, data integrity, data quality.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ALCOA++", "definition": "CDISC Definition: An extension to ALCOA+ (A-Attributable; L-Legible; C-Contemporaneous; O-Original; A-Accurate; + Complete, Consistent, Enduring, Available) to include traceability. [After Tetrascience ALCOA++ principles for data integrity Fact Sheet] See also ALCOA, ALCOA+, data integrity, data quality.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "alert", "definition": "CDISC Definition: To cause a high-priority signal (or warning) to be transmitted to the relevant stakeholder by way of the local system or another system (usually according to an established set of rules). For example, the system may transmit an alert to a patient's cardiologist that the patient has experienced another heart attack. another example is that the pharmacy system may transmit an alert to the prescribing physician that a potentially dangerous drug-drug interaction may occur based on the current list of medications. another example is that the system may notify a patient's physician that laboratory results (that are not within normal limits) are available. [HL7 EHR-SFM Glossary of Terms, 2010]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "algorithm", "definition": "CDISC Definition: Step-by-step procedures for making a series of choices among alternative decisions to reach a calculated result or decision. NOTE: An algorithm may be used clinically to guide treatment decisions for an individual patient on the basis of the patient's clinical outcome or result. [after AMA Style Guide, 9th Edition]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "alpha error", "definition": "CDISC Definition: The likelihood that a relationship observed between two variables is due to chance. The probability of a Type 1 error. [Modified from AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "amendment", "definition": "CDISC Definition: A written description of a change(s) to, or formal clarification of, a document.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "American National Standards Institute (ANSI)", "definition": "CDISC Definition: Founded in 1918, ANSI itself does not develop standards. ANSI's roles include serving as the coordinator for US voluntary standards efforts, acting as the approval body to recognize documents developed by other national organizations as American National Standards, acting as the US representative in international and regional standards efforts, and serving as a clearinghouse for national and international standards development information. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "analysis dataset", "definition": "CDISC Definition: An organized collection of data or information with a common theme arranged in rows and columns and represented as a single file; comparable to a database table. NOTE: standardizing analysis datasets is intended to make review and assessment of analysis more consistent [ADaM].", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "analysis set", "definition": "CDISC Definition: A set of subjects whose data are to be included in the main analyses. This should be defined in the statistical section of the protocol. NOTE: There are a number of potential analysis sets, including, for example, the set based upon the intent-to-treat principle. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "analysis variables", "definition": "CDISC Definition: Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. See also variable.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "analysis", "definition": "CDISC Definition: The process of mathematically summarizing and comparing data to confirm or refute a hypothesis. [AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "anchor", "definition": "CDISC Definition: Designation for a planned activity, often marking the transition between epochs or elements of a clinical study plan (e.g., \"FPFV-first patient first visit\").", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "anonymization", "definition": "CDISC Definition: The process of protecting privacy that removes the association between the identifying data and the data subject. In anonymized data, the patient cannot be identified by the recipient of the information. [ISO TS 25237:2008; TransCelerate Protection of Personal Data in Clinical Documents - A Model Approach]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "antagonistic effect", "definition": "CDISC Definition: An interaction between bioactive compounds or drugs that is deemed to be less than the sum of each individual component. NOTE: The terms additivity, synergism, and antagonism should be used with care, unless the specific pharmacological pathways or mechanisms of action of the investigated drugs are known. [After Calzetta L, Koziol-White C. Pharmacological interactions: Synergism, or not synergism, that is the question. Curr Res Pharmacol Drug Discov. 2021 Aug 11;2:100046.] See also synergistic effect, antagonistic effect, drug interaction.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "antibody", "definition": "CDISC Definition: A type of protein made by B lymphocytes in response to a foreign substance (antigen). Each antibody only binds to a specific antigen, helping to destroy the antigen directly or by assisting white blood cells to destroy the antigen. [NCI] See also antigen, immune system, autoimmunity.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "anticipated adverse event", "definition": "CDISC Definition: Other adverse events that are not study endpoints and are not \"expected\" (i.e., because they are not in the investigator's brochure) that can be anticipated to occur with some frequency during the course of the trial, regardless of drug exposure, depending on the patient population and disease under study. NOTE: Examples of such \"anticipated\" events include known consequences of the underlying disease or condition under investigation, events anticipated from any background regimen, or re-emergence or worsening of a condition relative to pretreatment baseline. [after FDA, Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "antigen", "definition": "CDISC Definition: Any substance, generally a protein, that stimulates the immune system and elicits an immune response. Recognition by the immune system elicits either a T-lymphocyte response, recognizing processed antigens, or a B-lymphocyte response, producing antibodies that bind to unprocessed antigens. [NCI] See also antibody, immune system, autoimmunity.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "applet", "definition": "CDISC Definition: A small application, typically downloaded from a server.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "applicable regulatory requirement(s)", "definition": "CDISC Definition: Any law(s) or regulation(s) addressing the conduct of clinical trials of investigational products. [ICH E6(R2) Glossary, 1.4]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "approvable letter", "definition": "CDISC Definition: An official communication from FDA to an NDA/ BLA sponsor that lists issues to be resolved before an approval can be issued. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "approval (in relation to Institutional Review Boards)", "definition": "CDISC Definition: The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. [ICH E6]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "approval letter", "definition": "CDISC Definition: An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "artificial intelligence (AI)", "definition": "CDISC Definition: A system's ability to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation. NOTE: Types of artificial intelligence include generative AI and large language models. [Kaplan, A; Haenlein, M (1 January 2019) Business Horizons; IEEE-USA POSITION STATEMENT. Artificial Intelligence Research, Development & Regulation Adopted by the IEEE-USA, Board of Directors (February 2017); After FDA Medical Products Paper: Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, March 2024] See also machine learning, deep learning, natural language processing, synthetic data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "assent form", "definition": "CDISC Definition: A document explaining all the relevant information to assist an individual, who is unable to give informed consent on their own behalf, in understanding the expectations and risks in making a decision about a procedure.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "assessment", "definition": "CDISC Definition: The interpretation or evaluation of an obtained value by using a test, tool, instrument, or expert judgement of the status of a study subject. [After BEST Resource] See also variable, outcome, endpoint.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "attributable", "definition": "CDISC Definition: A quality by which records and data can be traced back to the subject to whom they pertain, as well as to those persons who have acted on the records.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "attribute (n)", "definition": "CDISC Definition: In data modeling, refers to specific items of data that can be collected for a class.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "audit certificate", "definition": "CDISC Definition: Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharmaceutical company). [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "audit report", "definition": "CDISC Definition: A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "audit trail", "definition": "CDISC Definition: A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record. [after ICH E6, CSUICI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "audit", "definition": "CDISC Definition: A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "authorised auxiliary medicinal product", "definition": "CDISC Definition: A medicinal product that is currently authorised for marketing in a country or region, that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product, regardless of labelling of the auxiliary medicinal product. [after EU CTR]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "authorised investigational medicinal product", "definition": "CDISC Definition: A medicinal product that is currently authorised for marketing in a country or region and used as an investigational medicinal product, irrespective of changes to the labelling of the medicinal product. [After EU CTR (EU) No 536/2014] See also investigational medicinal product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "authorization", "definition": "CDISC Definition: The process of giving someone permission to do or have something. In multi-user computer systems, a system administrator defines for the system which users are allowed access to the system and what privileges of use are permitted. [HL7 EHR-S FM Glossary of Terms, 2010].", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "autoimmunity", "definition": "CDISC Definition: An attack response of the immune system against the body's own components. [Janeway CA Jr, Travers P, Walport M, et al. Immunobiology: The Immune System in Health and Disease. 5th edition. New York: Garland Science; 2001. Autoimmune responses are directed against self antigens. Available from: https://www.ncbi.nlm.nih.gov/books/NBK27155/] See also immune system, antibody, antigen.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "auxiliary medicinal product", "definition": "CDISC Definition: A medicinal product that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product. NOTE: Auxiliary medicinal products may be authorised for marketing in a country or region or non-authorised. [after EU-CTR]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "back translation (natural language)", "definition": "CDISC Definition: The process of translating a document that was translated from one language to another back to the original language. Used to ensure that consent forms, surveys, and other clinical trial documents will be clear and accurate in the translated form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "background material", "definition": "CDISC Definition: Information pertinent to the understanding of a protocol. NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "background treatment", "definition": "CDISC Definition: Medicinal products that are administered to each clinical trial subject, regardless of randomization group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "balanced study", "definition": "CDISC Definition: Trial in which a particular type of subject is equally represented in each study group.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "bandwidth", "definition": "CDISC Definition: An indicator of the throughput (speed) of data flow on a transmission path; the width of the range of frequencies on which a transmission medium carries electronic signals. All digital and analog signal channels have a bandwidth.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "baseline assessment", "definition": "CDISC Definition: Assessment of subjects as they enter a trial and before they receive any treatment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "baseline characteristics", "definition": "CDISC Definition: Demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered. NOTE: Randomized, controlled trials aim to compare groups of participants that differ only with respect to the intervention (treatment). although proper random assignment prevents selection bias, it does not guarantee that the groups are equivalent at baseline. any differences in baseline characteristics are, however, the result of chance rather than bias. The study groups should be compared at baseline for important demographic and clinical characteristics. Baseline data may be especially valuable when the outcome measure can also be measured at the start of the trial. [CONSORT statement]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "baseline imbalance", "definition": "CDISC Definition: A systematic error in creating intervention groups, such that they differ with respect to prognosis. That is, the groups differ in measured or unmeasured baseline characteristics because of the way participants were selected or assigned. NOTE: also used to mean that the participants are not representative of the population of all possible participants. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "basket trial design", "definition": "CDISC Definition: A type of trial design under a master protocol designed to test a single investigational drug or drug combination in different populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "basket trial", "definition": "CDISC Definition: A type of trial conducted under a master protocol and designed to test a single investigational drug or drug combination in different populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022; Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.]. See also basket trial design, adaptive design, master protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Bayesian approaches", "definition": "CDISC Definition: Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g., treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference. [ICH E9 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Bayesian statistics", "definition": "CDISC Definition: Statistical approach named for Thomas Bayes (1701-1761) that has among its features giving a subjective interpretation to probability, accepting the idea that it is possible to talk about the probability of hypotheses being true and of parameters having particular values.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "benefit summary", "definition": "CDISC Definition: A description of any physical, psychological, social, or other potential positive effects to individual participants as a result of participating in the study, addressing immediate potential benefits and/or long-range potential benefits. NOTE: In a benefit summary, no or minimal benefits must also be described. [After ICH M11] See also clinical benefit, treatment benefit.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "beta error", "definition": "CDISC Definition: Probability of showing no significant difference when a true difference exists; a false acceptance of the null hypothesis. See also Type 2 error. [AMA Manual of style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "bias", "definition": "CDISC Definition: Bias refers to defects in study design, measurement, analysis or interpretation such that they cause a result to depart from the true value in a consistent direction. [after AMA Manual of style, ICH E9, CONSORT Statement]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "bioanalytical assays", "definition": "CDISC Definition: Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "bioavailability", "definition": "CDISC Definition: Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biobanking", "definition": "CDISC Definition: The storage of collected biospecimens for future use. (After NHMRC (2010) National Health and Medical Research Council \"Biobanks information paper\". Canberra. https://www.nhmrc.gov.au/sites/default/files/documents/attachments/Biobanks-information-paper-2010.pdf) See also biospecimen, biorepository.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "bioequivalence", "definition": "CDISC Definition: Scientific basis on which drugs with the same active ingredient(s) are compared. NOTE: To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biological product", "definition": "CDISC Definition: A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition. Such products may include virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product. NOTE: Biological products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. Biological products are generally large, complex molecules and are often more difficult to characterize than small molecule drugs. [After 21 CFR 600.3; After FDA Biological Product Definitions] See also vaccine, cell therapy, gene therapy, pharmaceutical product, drug product, medicinal product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Biologics licensing application (BLA)", "definition": "CDISC Definition: Biologics licensing application (BLA). an application to FDA for a license to market a new biologic product in the United states.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biomarker", "definition": "CDISC Definition: A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives. Categories of biomarkers include: susceptibility/risk biomarker; diagnostic biomarker; monitoring biomarker; prognostic biomarker; predictive biomarker; safety biomarker; pharmacodynamic/response biomarker. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biometric signature", "definition": "CDISC Definition: A signature based on the verification of an individual's identity, based on measurement of the individual's physical feature(s) or repeatable action(s), where those features and/or actions are both unique to that individual, and measureable [21 CFR 11]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biorepository", "definition": "CDISC Definition: A storage facility for biospecimens. NOTE: The biorepository has stringent guidelines regarding the standardized collection, handling, storage, and documentation of biological specimens. See also biobanking, biospecimen.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biosimilar", "definition": "CDISC Definition: A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components. This requires that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product (see section 351(i)(2) of the PHS Act). [after FDA, Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biospecimen", "definition": "CDISC Definition: Any material from a biological entity used for testing, diagnostic, propagation, treatment, or research purposes. [See SDTM codelists: https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C78734; https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C111114] See also biobanking, biorepository.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "biostatistics", "definition": "CDISC Definition: Branch of statistics applied to the analysis of biological phenomena.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "blind review", "definition": "CDISC Definition: Checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis. [Modified ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "blinded (masked) medications", "definition": "CDISC Definition: Products that appear identical in size, shape, color, flavor, and other attributes to make it very difficult for subjects and investigators (or anyone assessing the outcome) to determine which medication is being administered.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "blinded study", "definition": "CDISC Definition: A study in which the subject, the investigator, or anyone assessing the outcome is unaware of the treatment assignment(s). NOTE: Blinding is used to reduce the potential for bias. [Modified ICH E6 Glossary] See also blinding/masking, double-blind study, single-blind study, triple-blind study; contrast with open-label or unblinded study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "blinding", "definition": "CDISC Definition: A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. [After Abhaya Indrayan, Martin P. Holt. Concise Encyclopedia of Biostatistics for Medical Professionals. Chapman & Hall; November 17, 2016] See also double-blind study, single-blind study, triple-blind study. Contrast with open-label and/or unblinded study, masking.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "blood draw", "definition": "CDISC Definition: The collection of blood from a vein, most commonly via needle venipuncture. (NCI)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "branch", "definition": "CDISC Definition: Point within a study design where there is an allocation of subject subsets to particular procedures or treatment groups.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "browser", "definition": "CDISC Definition: Computer program that runs on the user's desktop computer and is used to navigate the World Wide Web. See also web browser.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cache", "definition": "CDISC Definition: Storage area on a computer's hard drive where the browser stores (for a limited time) web pages and/or graphic elements.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "carry-over effect", "definition": "CDISC Definition: Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication's known biological activity.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "case history", "definition": "CDISC Definition: An adequate and accurate record prepared and maintained by an investigator that records all observations and other data pertinent to the investigation of each individual administered the investigational drug (device or other therapy) or employed as a control in the investigation. NOTE: Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study. [21 CFR 312.62(b)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "case report form (CRF)", "definition": "CDISC Definition: A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject. NOTE: In common usage, CRF can refer to either a CRF page, which denotes a group of one or more data items, linked together for collection and display, or a casebook, which includes the entire group of CRF pages on which a set of clinical study observations can be or have been collected by completion of such CRF pages for a subject in a clinical study. See also CRF (paper), eCRF. [ICH E6 Glossary, FDA Final Guidance on eSource].", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "case report tabulations (CRT)", "definition": "CDISC Definition: In a paper submission, listings of data that may be organized by domain (type of data) or by subject. See also eCRT.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "case-control study", "definition": "CDISC Definition: A study in which individuals to an outcome (cases) are compared with those who do not have the outcome (controls). NOTE: The outcome variable (disease, event, experience, biomarker) is chosen first, and the exposure is evaluated in cases vs controls to see whether there is an association between exposure and outcome. [After AMA Manual of Style] See also outcome, observational study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "categorical data", "definition": "CDISC Definition: Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "causality assessment", "definition": "CDISC Definition: An evaluation performed by a medical professional concerning the likelihood that a therapy or product under study caused or contributed to an adverse event.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDISC Library", "definition": "CDISC Definition: A global, accessible, electronic library, which, through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. NOTE: Formerly known as CDISC SHARE. [CDISC]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CDISC standards", "definition": "CDISC Definition: A set of models, implementation guides, controlled vocabularies, and exchange formats developed by the Clinical Data Interchange Standards Consortium (CDISC), which are intended to provide for consistent use of common representations of data, terms and specifications. NOTE: These standards apply to translational research, electronic submission of clinical data, and the life-cycle of clinical product development, which includes protocol representation, data collection, aggregation, tabulation, and analysis and unambiguous information exchange across disparate systems. [After https://www.ncbi.nlm.nih.gov]. See also standard, data standards, Study Data Standardization Plan, and Standards Development Organization.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cell therapy", "definition": "CDISC Definition: The prevention or treatment of human disease by the administration of cells that have been selected, multiplied, and pharmacologically treated or altered outside the body (ex vivo), or methods (pharmacological as well as nonpharmacological) to modify the function of intrinsic cells of the body for therapeutic purposes (in vivo). NOTE: Cell therapies can be classified based on therapeutic indication, cell type, source of cells, and underlying technology, among others, in medical and regulatory contexts. [After https://www.sciencedirect.com/topics/neuroscience/cell-therapy; After Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007.] See also regenerative medicine therapy, regenerative medicine advanced therapy, gene therapy, biological product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "certified copy", "definition": "CDISC Definition: A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. [ICH E6 (R2)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "certified IRB professional (CIP)", "definition": "CDISC Definition: Persons certified to participate on an institutional review board, who satisfy the educational and employment requirements and pass an examination conducted by the applied Research ethics national association (aRena), the membership division of Public Responsibility in Medicine and Research (PRiM&R).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "challenge agent", "definition": "CDISC Definition: A non-investigational medicinal product (NIMP) given to trial subjects to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product can be assessed. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CHI (consolidated health informatics)", "definition": "CDISC Definition: CHI began as an eGov initiative to establish a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to \"speak the same language\" based on common enterprise-wide business and information technology architectures. CHI is currently managed under the Office of the National Coordinator for Health Informational Technology's (ONC) Federal Health Architecture (FHA) Program Management Office. Ref: The United States Health Information Knowledgebase [USHIK]. [HITSP]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "class", "definition": "CDISC Definition: A definition of objects with properties (attributes, methods, relationships) that all objects in the class have in common. [HL7, 2001] in data modeling, a class defines a set of objects that share the same attributes, relationships, and semantics. A class is usually an entity that represents a person, place, or thing.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clean database", "definition": "CDISC Definition: A set of reviewed data in which errors have been resolved to meet QA requirements for error rate and in which measurements and other values are provided in acceptable units; database that is ready to be locked. See also database lock, clean file.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clean file", "definition": "CDISC Definition: When all data cleaning is completed and database is ready for quality review and unblinding.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "client", "definition": "CDISC Definition: A program that makes a service request of another program, usually running on a server, that fulfills the request. Web browsers (such as Firefox and Microsoft explorer) are clients that request HTML files from web servers.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical benefit", "definition": "CDISC Definition: A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a subject feels. See also benefit summary, treatment benefit.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical clarification", "definition": "CDISC Definition: A query resolution received from the sponsor staff (medical monitors, DSMB monitoring board, etc.). See also self-evident change.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical data", "definition": "CDISC Definition: Data pertaining to the medical well-being or status of a patient. Category also includes clinical reports and individual patient data (IPD) as defined in the EMA Policy 0070 Implementation Guide. [http://www.ema.eoropa.eu/docs/en_GB/document_library/REPORT/2014/10/WC500174378.PDF]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical development plan", "definition": "CDISC Definition: A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. NOTE: The plan should have appropriate decision points and allow modification as knowledge accumulates. [from ICH E9] See also development plan.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical document architecture", "definition": "CDISC Definition: Specification for the structure and semantics of \"clinical documents\" for the purpose of exchange. [HL7; SPL]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical document", "definition": "CDISC Definition: A documentation of clinical observations and services. NOTE: an electronic document should incorporate the following characteristics: persistence, stewardship, potential for authentication, wholeness, and human readability. [SPL]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical efficacy", "definition": "CDISC Definition: Power or capacity to produce a desired effect (i.e., appropriate pharmacological activity in a specified indication) in humans. [SQA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical encounter", "definition": "CDISC Definition: Contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Contact may be physical or virtual. [CDISC]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical hold (of a clinical trial)", "definition": "CDISC Definition: An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42] See also suspension (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical investigation", "definition": "CDISC Definition: Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Considered synonymous with clinical research by FDA. See clinical study, clinical trial. [FDA Science & Research]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical outcome assessment (COA) qualification", "definition": "CDISC Definition: A formal conclusion by FDA that, within the stated context of use, the results of the COA measurement can be relied upon to have a specific interpretation and application. NOTE: For qualified COAs, FDA permits drug developers to use the COA in the qualified context in IND and NDA/BLA submissions without requesting that the relevant CDER review group reconsider and reconfirm the suitability of the COA. [FDA Clinical Outcome Assessment (COA) Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical outcome assessment (COA)", "definition": "CDISC Definition: Any assessment that may be influenced by human choices, judgment, or motivation and may support or refute treatment benefit. NOTE: Unlike biomarkers that rely completely on an automated process or algorithm, COAs reflect interpretation of reporting from a patient, a clinician, or an observer. There are four types of COAs. See also patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO). [FDA Clinical Outcome Assessment (COA) Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical pharmacology", "definition": "CDISC Definition: Science that deals with the characteristics, effects, properties, reactions, and uses of drugs, particularly their therapeutic value in humans, including their toxicology, safety, pharmacodynamics, and pharmacokinetics (ADME).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical research and development", "definition": "CDISC Definition: The testing of a drug compound in humans primarily done to determine its safety and pharmacological effectiveness. Clinical development is done in phases, which progress from very tightly controlled dosing of a small number of subjects to less tightly controlled studies involving large numbers of patients. [SQA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical research associate (CRA)", "definition": "CDISC Definition: Person employed by a study sponsor or by a contract research organization (CRO) acting on a sponsor's behalf, who monitors the status, data integrity, and protocol adherence of investigator sites participating in a clinical study. See also sponsor.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical research coordinator (CRC)", "definition": "CDISC Definition: A qualified study staff member who manages the participation of subjects according to the study protocol. NOTE: CRCs coordinate communication among the subject, investigator, and sponsor. Responsibilities may also include screening, enrollment, monitoring of potential participants, and informed consent. [After Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research Cavalieri Jennifer and Rupp Mark Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research 336pp US$44.95 Sigma Theta Tau 9781937554637 1937554635 [Formula: see text]. Nurs Manag (Harrow). 2014 Aug 28;21(5):13.; After SOCRA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical research subject", "definition": "CDISC Definition: A person who is enrolled into a clinical study or trial. See also study, trial, and study population.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical significance", "definition": "CDISC Definition: Change in a subject's clinical condition regarded as important whether or not due to the test intervention. NOTE: some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol. The term \"clinical significance\" is not advisable unless operationally defined.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical study data element", "definition": "CDISC Definition: A single observation associated with a subject in a clinical study. A data element in an eCRF represents the smallest unit of observation captured for a subject in a clinical investigation. NOTE: Examples include birth date, white blood cell count, pain severity measure, and other clinical observations made and documented during a study. Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. See also eCRF, data element identifier, data originator, item. [After FDA Guidance for Industry Electronic Source Data in Clinical Investigations , Body text and Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical study report", "definition": "CDISC Definition: A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. NOTE: For further information, see the ICH Guideline for Structure and Content of Clinical Study Reports. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical study", "definition": "CDISC Definition: A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial authorization", "definition": "CDISC Definition: Authorization granted by a Medicines Regulatory Agency to conduct a clinical trial in a jurisdiction. NOTE: If an ethical committee allows a trial to proceed it is called an approval to proceed. [After ISO 11615:2017, 3.1.12]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial data", "definition": "CDISC Definition: Data collected in the course of a clinical trial. See also clinical trial information.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial exemption (CTX)", "definition": "CDISC Definition: A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application (generally within 35 working days). NOTE: Approval means that the company is exempt from the requirement to hold a clinical trial certificate (CTC). [UK]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial information", "definition": "CDISC Definition: Data collected in the course of a clinical trial or documentation related to the integrity or administration of that data. A superset of clinical trial data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial materials", "definition": "CDISC Definition: Complete set of supplies provided to an investigator by the trial sponsor.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial registry", "definition": "CDISC Definition: A web-based publicly accessible platform for providing structured information about clinical trials. NOTE: Such registries help patients, family members, health care professionals, researchers, and the public identify studies in which they might participate. Some registries include clinical trial results. Examples include: EU Clinical Trials Register (EU CTR), for studies in the EU or the EEA after 1 May 2001; ClinicalTrials.gov, a web-based resource from the National Library of Medicine (NLM) in the US. [After International Committee of Medical Journal Editors]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial results registry", "definition": "CDISC Definition: A web-based publicly accessible platform for providing structured summary results information about clinical trials. See also clinical trial registry.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinical trial", "definition": "CDISC Definition: A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation, randomized controlled trial (RCT).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "clinician-reported outcome (ClinRO)", "definition": "CDISC Definition: A type of clinical outcome assessment. A measurement based on a report that comes from a trained health-care professional after observation of a patient's health condition. [After BEST Resource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "co-packaged product", "definition": "CDISC Definition: Two or more separate products packaged together in a single package or as a unit and composed of drug and device products, device and biological products, or biological and drug products. [After 21 CFR 3.2 (e) FAQ] See also combination product, single-entity product, cross-labeled product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "codelist", "definition": "CDISC Definition: Finite list of codes and their meanings that represent the only allowed values for a data item. A codelist is one type of controlled vocabulary. See also controlled vocabulary.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "coding", "definition": "CDISC Definition: In clinical trials, the process of assigning data to categories for analysis. NOTE: Adverse events, for example, may be coded using MedDRA.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cognitive debriefing", "definition": "CDISC Definition: A qualitative research tool used to determine whether concepts and items are understood by patients in the same way that PRO instrument developers intend. NOTE: Cognitive debriefing interviews involve incorporating follow-up questions in a field test interview to gain better understanding of how patients interpret questions asked of them and to collect and consider all concepts elicited by an item. [from PRO Draft Guidance Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cohort study", "definition": "CDISC Definition: Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. NOTE: Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study, cohort.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cohort", "definition": "CDISC Definition: A group of individuals who share a common exposure, experience or characteristic or a group of individuals followed-up or traced over time in a cohort study. [AMA Manual of Style] See also cohort study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "combination product", "definition": "CDISC Definition: A product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another and are referred to as \"constituent parts\" of the combination product). NOTE: A combination product might be a single-entity product, a co-packaged product or a cross-labeled product. [After 21 CFR 3.2 (e)] See also single-entity product, co-packaged product, cross-labeled product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "commercially confidential information (CCI)", "definition": "CDISC Definition: Any information contained in clinical reports or other documents that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the company (the Marketing Application Holder) and cause harm (if disclosed). [After EMA Policy 0070 implementation Guide]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "common data element (CDE)", "definition": "CDISC Definition: A structured item characterized by a stem and response options together with a history of usage that can be standardized for research purposes across studies conducted by and for NIH. NOTE: The mark up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [NCI, CaBIG]. See also item, item (PRO), stem, data element, data element identifier.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Common Technical Document", "definition": "CDISC Definition: A format agreed upon by ICH to organize applications to regulatory authorities for registration of pharmaceuticals for human use. [ICH] See also eCTD.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Comparative Effectiveness Research (CER)", "definition": "CDISC Definition: A type of study in which the intervention of interest is compared against another intervention(s) of interest to see if there is evidence about the effectiveness, benefits and harms of different treatment options. [NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "comparative study", "definition": "CDISC Definition: One in which the investigative drug is compared against another product, either active drug or placebo.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "comparator (product)", "definition": "CDISC Definition: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. [ICH E6 Glossary] See also control.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "compendial name", "definition": "CDISC Definition: A name within a pharmaceutical compendium that designates a small or large molecule substance that complies with compendial standards for strength, quality, and purity. NOTE: Used for all drugs within the US. [After USP Nomenclature Guidelines (last revision on March 30, 2020)] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Competent Authority (CA)", "definition": "CDISC Definition: The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "compliance (in relation to trials)", "definition": "CDISC Definition: Adherence to specifications in the study protocol and regulations by patients, investigators, and other study staff. NOTE: The investigator and sponsor have obligations to follow the protocol and GCP. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000.]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "computer application", "definition": "CDISC Definition: Software designed to fill specific needs of a user; for example, software for navigation, project management, or process control.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "concept of interest", "definition": "CDISC Definition: In the context of clinical outcomes, the thing measured by a COA assessment (e.g., pain intensity). [After Clinical Outcome Assessment (COA) Glossary of Terms FDA FDA eCOA Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "concept", "definition": "CDISC Definition: Discrete notion having a single meaning. In a controlled vocabulary a concept is mapped to one or more of the words that convey its meaning.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "concerned member state (CMS)", "definition": "CDISC Definition: A classification of a Member States in the Mutual Recognition Procedure (MRP) in the European authorization route resulting in a mutually recognized product. In the Mutual Recognition Procedure, one or more Member States that is a CMS is asked to mutually recognize the Market Authorization of the Reference Member State (RMS). [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html] See also Mutual Recognition Procedure (MRP) and Reference Member State (RMS).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "concomitant medication", "definition": "CDISC Definition: Any product that is taken by clinical trial participants that is not the investigational medicinal product or auxiliary medicinal product, and is not relevant for the design of the clinical trial. [After Regulation (EU) no 535/2014 Clinical Trials on medicinal products for human use] See also Investigational medicinal product, auxiliary medicinal product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "conduct", "definition": "CDISC Definition: An ongoing and/or past performance of a formal investigation as specified in a study protocol. [NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "confidence interval (CI)", "definition": "CDISC Definition: A measure of the precision of an estimated value. The interval represents the range of values, consistent with the data, that is believed to encompass the \"true\" value with high probability (usually 95%). The confidence interval is expressed in the same units as the estimate. Wider intervals indicate lower precision; narrow intervals, greater precision. [CONSORT Statement]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "confidentiality", "definition": "CDISC Definition: Prevention of disclosure to other than authorized individuals of a sponsor's proprietary information or of a subject's identity. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "confirmatory trial", "definition": "CDISC Definition: Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result, pragmatic trial. Compare to exploratory trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "conformity assessment", "definition": "CDISC Definition: The process by which compliance with the EMA's essential requirements is assessed. See also Notified Body (NB).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "confounding variable", "definition": "CDISC Definition: A factor that may interfere with the interpretation of the effect of an exposure on an outcome. [After AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "consent form", "definition": "CDISC Definition: Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. it is designed to begin the informed consent process, which consists of conversations between the subject and the research team. if the individual then decides to enter the trial, s/he gives her/his official consent by signing the document. Informed consent is sometimes administered electronically, i.e., eICF. See also informed consent.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "construct validation (COA)", "definition": "CDISC Definition: Establishing, using quantitative methods, the extent to which the relationships among items, domains, and concepts of a clinical outcome assessment (COA) conform to a priori hypotheses concerning logical relationships that should exist with other measures or characteristics of patients and patient groups. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "consumer safety officer (CSO)", "definition": "CDISC Definition: FDA official who coordinates the review process of various applications.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "content validation (COA)", "definition": "CDISC Definition: Establishing from qualitative research the extent to which the clinical outcome assessment (COA) instrument measures the concept of interest including evidence that the items and domains of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "content validity", "definition": "CDISC Definition: The extent to which a variable (for example, a rating scale) measures what it is supposed to measure. [ICH E9 Glossary] evidence from qualitative research demonstrating that the instrument measures the concept of interest, including evidence that the items and domains of an instrument are appropriate and comprehensive, relative to its intended measurement concept, population, and use. NOTE: Testing other measurement properties will not replace or rectify problems with content validity. [FDA Final PRO Guidance]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "context of use", "definition": "CDISC Definition: In the context of clinical outcomes, a comprehensive statement that fully and clearly describes and justifies the way a COA is to be used and the drug development-related purpose of the use. NOTE: The context of use defines the boundaries within which the available data adequately justify use of the COA and describes important criteria regarding the circumstances under which the COA is qualified. [FDA Clinical Outcome Assessment (COA) Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "contingent subject trial contact", "definition": "CDISC Definition: Planned response to an anticipated but conditional event in a clinical trial. [CDISC Trial Design Project]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "contract research organization (CRO)", "definition": "CDISC Definition: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "contract", "definition": "CDISC Definition: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "control group", "definition": "CDISC Definition: A cohort of study participants that is defined for the purpose of comparison to the treatment group in a controlled trial. NOTE: In an epidemiological study, this cohort may or may not have the outcome of interest. [After 21 CFR 314.126] See also control, controlled study, arm (protocol).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "control of electronic records", "definition": "CDISC Definition: To prepare and maintain case histories and other records for regulated clinical investigations or other regulated research. NOTE: Control is often used as a casual synonym for the terms in 21 CFR 312.62 requiring investigative sites to prepare, maintain, and retain adequate and accurate case histories. [After 1. 21 CFR 11; 2. CSUCT] See also record.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "control", "definition": "CDISC Definition: A comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature, synthetic data)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol), synthetic data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "controlled study", "definition": "CDISC Definition: A study in which a test article is compared with a treatment that has known effects (active control), no treatment, placebo, or dose comparison concurrent control, or external (historic) control. [21 CFR 314.126 and ICH E10]. See also control, comparator (product), control group.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "controlled vocabulary", "definition": "CDISC Definition: A finite set of values that represent the only allowed values for a data item. These values may be codes, text, or numeric. See also codelist.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "coordinating committee", "definition": "CDISC Definition: A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. [ICH E6]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "coordinating investigator", "definition": "CDISC Definition: An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. NOTE: Depending on the scope of the trial, coordination could be across centers/sites in a region, across regions, or within a nation. [ICH E6] See also investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "correlation", "definition": "CDISC Definition: The degree to which two or more variables are related. Typically the linear relationship is measured with either Pearson's correlation or spearman's Rho. NOTE: Correlation does not necessarily mean causation. [After Hyperstat Online Glossary; CDISC ADaM]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "covariate (prognostic)", "definition": "CDISC Definition: Factor or condition that influences outcome of a trial. [ADaM]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRF (paper)", "definition": "CDISC Definition: Case report form in which the data items are linked by the physical properties of paper to particular pages. NOTE: Data are captured manually and any comments, notes, and signatures are also linked to those data items by writing or typescript on the paper pages. See also eCRF, case report form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CRF data", "definition": "CDISC Definition: Subset of clinical trial data that are entered into fields on a case report form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "criterion validation (COA)", "definition": "CDISC Definition: Establishing the extent to which the scores of a clinical outcome assessment instrument are related to a known gold standard measure of the same concept. For most COAs clinical outcome assessments (COAs), criterion validity cannot be measured because there is no gold standard. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cross-labeled product", "definition": "CDISC Definition: An investigational drug, device, or biological product packaged separately that, according to its proposed labeling, is intended for use only with another investigational or approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect. NOTE: In the case where an approved product is combined with an investigational product, upon approval of the cross-labeled product the label of the previously approved product should be modified to reflect the combination status. [After 21 CFR 3.2 (e) FAQ] See also combination product, single-entity product, co-packaged product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cross-sectional study", "definition": "CDISC Definition: A study that measures the prevalence of health outcomes or determinants of health, or both, in a population at a point in time or over a short period. [After British Medical Journal, Epidemiology for the uninitiated, Chapter 8, Fifth Edition, BMJ Book 2004] See also observational study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "crossover trial", "definition": "CDISC Definition: A trial design in which subjects function as their own control and are assigned to receive an investigational product(s) and control(s) in an order determined by randomization, with or without a washout period between the interventions. [After ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CTCAE (Common Terminology Criterion for Adverse Events)", "definition": "CDISC Definition: Standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. NOTE: CTCAE is often used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. [After NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "CUI (common unique identifier)", "definition": "CDISC Definition: A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "curriculum vitae (CV)", "definition": "CDISC Definition: Document that outlines a person's educational and professional history.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "cybersecurity", "definition": "CDISC Definition: Protection of computers, servers, mobile devices, electronic systems, networks, programs, and data from malicious attacks, damage, or unauthorized access, to ensure confidentiality, integrity, and availability of information. [After FDA CDRH; After 17 CFR Part 229.106; After Cybersecurity and Infrastructure Security Agency]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data acquisition", "definition": "CDISC Definition: Capture of data into a structured, computerized format without a human-to-computer interface (i.e., from another measuring instrument or computerized source). Contrast with data entry, electronic data capture.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data capture", "definition": "CDISC Definition: The process of collecting and recording measures and assessments for a specific purpose. NOTE: Data are said to be captured when they are extracted as permanent records for use in a new context or created as a source document in that context. An example would be data that are manually copied or otherwise extracted from an EHR that are then transferred into a clinical trial database to be used for a clinical trial. [After Working with Data, Australian National Data Service, Accessed 4 Sept 2020; AFter FDA Guidance on Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry, July 2018] See also data entry, EDC (electronic data capture).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data clarification form", "definition": "CDISC Definition: A form used to query an investigator and collect feedback to resolve questions regarding data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data clarification", "definition": "CDISC Definition: Answer supplied by the investigator in response to a query. NOTE: The investigator may supply a new data point value to replace the initial value or a confirmation of the queried data point.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data coding", "definition": "CDISC Definition: The process of transforming raw data into a structured and manageable format, enabling researchers to identify patterns, themes, and relationships within their data. NOTE: It involves assigning labels or alphanumerical codes to different pieces of information based on predefined criteria or categories, or through the use of coding dictionaries such as MedDRA. These codes act as a bridge between the raw data and the analytical phase of research, facilitating the organization, integration, and interpretation of data. [Dr. Sowndarya Somasundaram, Data Coding in Research Methodology - iLovePhD, October 7, 2023, https://www.ilovephd.com/data-coding-in-research-methodology/, Accessed 2024-08-22] See also data, data management, data entry.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data collection instruments", "definition": "CDISC Definition: Documents or tools which are used to collect, record or transcribe information on substantially identical items from a group of respondents. NOTE: Instruments can be either electronic or paper based tests, questionnaires, inventories, interview schedules or guides, rating scales, and survey plans or any other forms. [After 45 CFR 63.32]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data collection", "definition": "CDISC Definition: In the context of clinical research, accessing and recording information that provides source data for analysis and interpretation See data entry and data capture. [CDISC]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data controller", "definition": "CDISC Definition: The entity that determines which, and how, personal data are processed. [Article 4 GDPR Definitions] See also personal data, processing (personal data).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data element identifier", "definition": "CDISC Definition: An identifier that may include information such as the origin of the data element, the date and time of entry, or the identification number of the study subject to whom the data element applies. NOTE: Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. [After body and glossary of FDA Final Guidance eSource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data element", "definition": "CDISC Definition: Smallest unit of information in a transaction. [From body and glossary of FDA Final Guidance on eSource] See also eXtensible markup language (XML) data element, common data element, clinical study data element.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data encryption standard (DES)", "definition": "CDISC Definition: A FIPS approved cryptographic algorithm for encrypting (enciphering) and decrypting (deciphering) binary coded information. Encrypting data converts it to an unintelligible form called cipher. Decrypting cipher converts the data back to its original form called plaintext. NOTE: Data that are considered sensitive by the responsible authority or data that represent a high value should be cryptographically protected if vulnerable to unauthorized disclosure or undetected modification during transmission or while in storage. [After Federal Information Processing Standards (FIPS) Publication 46-2]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data entry", "definition": "CDISC Definition: Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition. Contrast with data acquisition, electronic data capture, direct entry. See also data collection, data capture.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data integrity verification", "definition": "CDISC Definition: Process of manually supervised verification of data for internal consistency.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data integrity", "definition": "CDISC Definition: A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. [After ICH E6; After MHRA GXP Data Integrity Guidance and Defintions, Revision 1, March 2018; After 21 CFR Part 11] See also ALCOA, ALCOA+, ALCOA++, traceability (data), data quality, electronic data transfer.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data interchange", "definition": "CDISC Definition: Transfer of information between two or more parties, which maintains the integrity of the contents of the data for the purpose intended. See also interoperability.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data item", "definition": "CDISC Definition: A named component of a data element. Usually the smallest component [ANSI]. See also data model, data element.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data listing", "definition": "CDISC Definition: Set of observations organized by domain.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data management conventions", "definition": "CDISC Definition: Procedures and policies for data management (e.g., documented procedure(s) for resolving self-evident changes). [ICH E6] See self-evident change.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data management", "definition": "CDISC Definition: Tasks associated with the entry, transfer, and/or preparation of source data and derived items for entry into a clinical trial database. NOTE: Data management could include database creation, data entry, review, coding, data editing, data QC, locking, or archiving; it typically does not include source data capture.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data minimization", "definition": "CDISC Definition: The requirement that personal data must be adequate, relevant, and limited to what is necessary in relation to the purposes for which they are collected and processed. [After GDPR Article 5(1)(c); After Article 4(1)(c) of EU Regulation 2018/1725] See also personal data, processing (personal data).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data model", "definition": "CDISC Definition: Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use. A data model uses symbolic conventions agreed to represent content so that content does not lose its intended meaning when communicated.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data monitoring committee (DMC)", "definition": "CDISC Definition: A group of independent experts who are appointed to monitor the safety and scientific integrity of a research intervention, protect the confidentiality of participant data, and to make recommendations to the sponsor regarding the stopping of the trial for safety, efficacy, or for futility. [After clinicaltrials.gov; Committee for Medicinal Products for Human Use (CHMP), 2005, EMA; FDA Establishment and Operation of Clinical Trial Data Monitoring Committees. March 2006]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data monitoring", "definition": "CDISC Definition: Process by which clinical data are examined for completeness, consistency, and accuracy for the duration of the study lifecycle. NOTE: Monitoring is undertaken by qualified study personnel following a specific process and auditable methods. See also ALCOA+", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data origin", "definition": "CDISC Definition: Source of information collected in the course of a clinical trial, specifically used to differentiate between data as collected versus data that are derived or calculated. NOTE: In CDISC, a metadata attribute defined for each dataset variable in the Define.xml document of an SDTM submission that refers to the source of a variable (e.g., CRF, derived, sponsor defined, PRO, etc.). See also data element originator.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data originator", "definition": "CDISC Definition: Metadata characterizing the entity creating a data element in an eCRF for a clinical investigation. NOTE: Per FDA Final Guidance on eSource, \"Each data element is associated with an origination type that identifies the source of its capture in the eCRF. This could be a person, a computer system, a device, or an instrument that is authorized to enter, change, or transmit data elements into the eCRF (also sometimes known as an author).\" See also data element, data element originator, origin. [CDISC, Note is from FDA Final Guidance on eSource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data processor", "definition": "CDISC Definition: Processes personal data as instructed by a data controller to support the relevant processing activities on a data controller's behalf. [Article 4 GDPR Definitions] See also personal data, processing (personal data).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data quality", "definition": "CDISC Definition: A dimension of data contributing its trustworthiness and pertaining to accuracy, sensitivity, validity, and suitability to purpose. NOTE: Key elements of data quality include attribution, legibility (decipherable, unambiguous), contemporaneousness, originality (i.e., not duplicated), accuracy (ALCOA), precision, completeness, consistency (logical, not out of range), and those who have modified the data. Scientists may reasonably trust data that are accurate (high quality) that have also been reviewed by investigators and protected from unauthorized alteration (high integrity). [After ICH E6; After MHRA GXP Data Integrity Guidance and Defintions, Revision 1, March 2018; After 21 CFR Part 11] See also ALCOA, ALCOA+, ALCOA++, traceability (data), data integrity, electronic data transfer.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data security", "definition": "CDISC Definition: Degree to which data are protected from the risk of accidental or malicious alteration or destruction and from unauthorized access or disclosure. [After US FDA 21 CFR Part 11] See also personal data, processing (personal data).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data selection criteria", "definition": "CDISC Definition: The rules by which particular data are selected and/ or transferred between the point of care and the patient record; subsequently, from the patient record to the database; and from database to inclusion in sub-population analyses.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data sharing", "definition": "CDISC Definition: Providing clinical trial data or access to data and final results to key stakeholders with the goal of increasing scientific knowledge and ultimately better therapies for patients. NOTE: guiding principles for data sharing: (1) maximize the benefits of clinical trials while minimizing the risks or harm of sharing clinical trial data, (2) respect individual participants whose data are shared, (3) increase public trust in clinical trials and the sharing of trial data, and (4) conduct the sharing of clinical trial data in a fair manner. [After National Academies of Sciences, Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Press, 2015, accessed 2022-09-07]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data standards", "definition": "CDISC Definition: Defined rules, conventions, guidelines, characteristics, methods, formats, and terminologies that provide structure and consistency for exchange and utilization of data. NOTE: Data standards may describe the elements and relationships necessary to achieve the unambiguous exchange of data between disparate information systems. [After https://www.fda.gov/media/124694/download Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry MARCH2019, NCI Thesaurus]. See also interoperability, standard, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data storage", "definition": "CDISC Definition: To maintain data by placing the data, or a copy of the data, onto an electronically accessible device for preservation (either in plain-text or encrypted format). [HL7 eHR-s FM Glossary of Terms, 2010].", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data subject", "definition": "CDISC Definition: In the context of privacy guidelines, An individual who is the subject of personal data, persons to whom data refers, and from whom data are collected, processed, and stored. [after ISO/TS 2537:2008; and EU GDPR] See also study participant, participant.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data transformations", "definition": "CDISC Definition: Algorithmic operations on data or data sets to achieve a meaningful set of derived data for analysis. [ADaM] See also derived variable.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data type", "definition": "CDISC Definition: Data types define the structural format of the data carried in the attribute and influence the set of allowable values an attribute may assume. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data validation", "definition": "CDISC Definition: Process used to determine whether data are accurate, authentic, complete, and/or compliant with applicable standards, rules, and conventions. NOTE: The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks. [After FDA.; ISO] See also data integrity, validation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "data", "definition": "CDISC Definition: Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means. [FDA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "database lock", "definition": "CDISC Definition: Action taken to prevent further changes to a clinical trial database or any equivalent clinical data storage system. NOTE: Locking of a database is done after review, query resolution, and a determination has been made that the database is ready for analysis.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "database", "definition": "CDISC Definition: A collection of data or information, typically organized for ease and speed of search and retrieval.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dataset", "definition": "CDISC Definition: A collection of structured data in a single file. [CDISC] Compare to analysis dataset, tabulation dataset.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "date of first enrollment", "definition": "CDISC Definition: Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. [Modified from ICH E3] Compare to study start date.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "de-identification", "definition": "CDISC Definition: The process of removing potentially identifying data or data elements to render data into a form that does not identify individuals and where identification is not likely to take place. NOTE: A general term for a process of removing the association between a set of identifying data and the data subject. Examples of potentially identifying data include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). [After ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; HIPAA: 45 CFR, 164.514] See also anonymization.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "de-identified information", "definition": "CDISC Definition: Records that have had enough personally identifiable information removed or obscured such that the remaining information does not identify an individual, and there is no reasonable basis to believe that the information can be used to identify an individual. [Guide to Protecting Personally Identifiable Information (PII): Special Publication NIST pubs/800-122]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "decentralized clinical trial (DCT)", "definition": "CDISC Definition: A trial in which data capture, administration of medication, and possibly other procedures are done at the subject's location, e.g., at home or by telemedicine, mobile technology, and local HCPs (like family physicians, general practitioners). NOTE: The procedures (entry of data, medical tests, clinical evaluations, objective measures, observations) for capturing safety and efficacy measurements and observations may be done in-person by a traveling clinician or nurse so DCTs are not necessarily virtual. The responsibility for preparation, maintenance and retention of source records may be allocated to a centralized investigator or sponsor investigator. [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also remote clinical trial, virtual, visit.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "decision rule", "definition": "CDISC Definition: Succinct statement of how a decision will be reached based upon the expected foreseen clinical benefits in terms of outcomes of the primary endpoint. [FDA documentation]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Declaration of Helsinki", "definition": "CDISC Definition: A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. it was originally adopted by the 18th World Medical assembly (Helsinki, Finland, 1964) and recently revised (64th WMA General Assembly, Fortaleza, Brazil, October 2013).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "deep learning", "definition": "CDISC Definition: A subset of machine learning that is part of the broader family of machine learning methodologies based on artificial neural networks. A deep neural network has multiple layers between input and output layers to progressively extract higher level features from the raw input. [After DeepAI Machine Learning Glossary and Terms] See also machine learning, artificial intelligence (AI).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Define-XML", "definition": "CDISC Definition: A table in XML that transmits metadata that describes any tabular dataset structure. NOTE: When used with the CDISC content standards, it provides the metadata for human and animal model tabular datasets such as SDTM, SEND, and ADaM. [After CDISC.org] See also eXtensible markup language (XML) data element, XML (eXtensible Markup Language).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "demographic data", "definition": "CDISC Definition: Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dependent variable", "definition": "CDISC Definition: A variable that is expected to change as a result of an experiment. Dependent variables are influenced by independent variables. [After AMA Manual of Style] See also independent variable.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "deployment", "definition": "CDISC Definition: Readying an electronic clinical trial system for field use by providing or disseminating capture devices, tokens, or passwords for users of an activated system. See activation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "derived variable", "definition": "CDISC Definition: New variable created as a function of existing variables and/or application of mathematical functions. See also variable, raw data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "design configuration", "definition": "CDISC Definition: Clinical trial design developed to compare treatment groups in a clinical trial. NOTE: The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. examples include: Parallel Group Design, Crossover Design, Factorial Designs. [After ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "development plan", "definition": "CDISC Definition: An ordered program of clinical trials, each with specific objectives. [adapted from ICH E9, see ICH E8]. See also clinical development plan.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "diagnose", "definition": "CDISC Definition: A process to identify the disease, condition, or injury that explains the symptoms and signs occurring in a patient. NOTE: The information required for diagnosis is collected from a history and physical examination of the patient and preferably confirmed by one or more diagnostic procedures such as laboratory tests, radiologic studies and other technical investigations. [After \\\"Making a diagnosis\\\", John P. Langlois, Chapter 10 in Fundamentals of clinical practice (2002). Mark B. Mengel, Warren Lee Holleman, Scott A. Fields. 2nd edition.] See also treatment, intervention, disease, sign, symptom.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "diagnostic device", "definition": "CDISC Definition: A class of medical devices intended to provide evidence for diagnosis. [After Regulation (EU) 2017/745; After US FDA, Referencing the Definition of \"Device\" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents, Nov 14, 2022] See also medical device, investigational device, in vitro diagnostic device.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "DIBD (development international birth date)", "definition": "CDISC Definition: The sponsor's first authorization to conduct a clinical trial in any country worldwide. NOTE: Used to start the annual period for the Development Safety Update Report (DSUR). [After CIOMS VII; ICH E2F]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "digital signature", "definition": "CDISC Definition: An electronic signature, based on cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters, such that the identity of the signer and the integrity of the data can be verified. [21 CFR 11]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "direct access", "definition": "CDISC Definition: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. NOTE: The party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "direct entry", "definition": "CDISC Definition: Recording of data by human or automated action where an electronic record is the original means of capturing the data into an electronic records system without a paper source document. Examples are an individual keying original observations into a system or the automatic recording into the system of the output from measuring devices such as a balance that measures subject's body weight or an ECG machine. Compare to data entry, data acquisition.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "direct identifier", "definition": "CDISC Definition: A piece of data that can be used to uniquely identify an individual (e.g., name, patient ID, social security number, exact address, telephone number, e-mail address, government issued identifiers, passport/VISA numbers) either without additional information or with cross-linking through other information that is in the public domain. [After PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "discontinuation", "definition": "CDISC Definition: The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a study. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. \"Termination of subject\" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A] See also withdrawal.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "discrepancy", "definition": "CDISC Definition: The failure of a data point to pass a validation check. NOTE: Discrepancies may be detected by computerized edit checks or observed/ identified by the data reviewer as a result of manual data review. See also query.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "disease", "definition": "CDISC Definition: Any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the affected person. NOTE: The term is often used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function. [After NCI Thesaurus] See also diagnosis.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "disease-free survival", "definition": "CDISC Definition: The length of time after treatment for a specific disease during which a patient survives with no sign of recurrence of the disease. [NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "document (HL7)", "definition": "CDISC Definition: An ordered presentation of XML elements, possibly including text and tabular analyses, description, and figures. Descriptors for HL7 documents include type, class, and element. NOTE: In HL7, a document can be either physical (referring to the paper) or logical (referring to the content) with the following characteristics: 1) Stewardship; 2) Potential for authentication; 3) Wholeness; 4) Human readability; 5) Persistence; 6) Global vs. local context.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "document root", "definition": "CDISC Definition: The element in an XML document that contains all other elements; the first element in the document. [SPL Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "document type definition (DTD)", "definition": "CDISC Definition: XML specification for content and presentation of data and text in a document including definitions for the elements considered to be legal in the document. NOTE: Agreeing on a common DTD facilitates interoperability among systems incorporating the agreed standards. [From Electronic Submission File Formats and Specifications. Orientation and Best Practices For Data Formats and Submission to The Center For Tobacco Products. January 2018; Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry. January 2019]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "documentation", "definition": "CDISC Definition: All records, in any form (including but not limited to written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "domain name", "definition": "CDISC Definition: The way a particular web server is identified on the internet. For example, www.fda.gov names the World Wide Web (www) server for the Food and Drug administration, which is a government (.gov) entity. [Center for advancement of Clinical Research]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "domain", "definition": "CDISC Definition: A collection of logically related observations with a common, specific topic that are normally collected for all subjects in a clinical investigation. NOTE: The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Example domains include laboratory test results (LB), adverse events (AE), concomitant medications (CM). [After SDTM Implementation Guide version 3.2, CDISC.org] See also general observation class.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dosage form", "definition": "CDISC Definition: Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. [After 21 CFR 314.3; After IDMP] See also drug product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dosage regimen", "definition": "CDISC Definition: The schedule of doses of an agent per unit of time, including the number of doses per given time period and the elapsed time between doses. NOTE: For example, every six hours or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [After AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dosage", "definition": "CDISC Definition: The amount of drug administered to a patient or test subject over a period of time; a regulated time bound administration of individual doses. NOTE: For example, a daily dosage specified in a prescription or a clinical trial, such as one 100mg tablet taken 4 times per day. [After AMA Manual of style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dose strength", "definition": "CDISC Definition: The strength of a drug product, which indicates the amount of each active ingredient in a single dose. For liquids, it is the proportion of each active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dose", "definition": "CDISC Definition: Specified quantity of a medicine, to be taken at one time or at stated intervals. [ISO 11615:2012 Health Informatics]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dose-escalation trial", "definition": "CDISC Definition: A study in which the dosage of the test article is increased until the desired physiological effect or toxicity is seen. (CDISC; After ICH E4)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "double-blind study", "definition": "CDISC Definition: A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows the treatment a subject is receiving. [After FDA Glossary of Terms]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "double-dummy", "definition": "CDISC Definition: A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. supplies are prepared for Treatment a (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). subjects then take two sets of treatment; either a (active) and B (placebo), or a (placebo) and B (active). [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dropout", "definition": "CDISC Definition: A subject in a clinical trial who for any reason fails to continue in the trial until the last visit or observation required of him/her by the study protocol. [from ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug development process", "definition": "CDISC Definition: The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug distribution", "definition": "CDISC Definition: In pharmacokinetics, the processes that control transfer of a drug from the site of measurement to its target and other tissues. See also ADME.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug interaction", "definition": "CDISC Definition: Changes in a drug's effects due to recent or concurrent use of another drug or drugs (drug-drug interactions), ingestion of food (drug-nutrient interactions), or ingestion of dietary supplements (dietary supplement-drug interactions). [MSD Manual Professional Version. Drug Interactions. By Shalini S. Lynch , PharmD, University of California San Francisco School of Pharmacy. Reviewed/Revised Jul 2022; Modified Sep 2022. Merck & Co, Inc., Rahway, NJ, USA] See also additive effect, synergistic effect, antagonistic effect.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug product", "definition": "CDISC Definition: A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21 CFR 210.3] See also medicinal product, dosage form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug treatment", "definition": "CDISC Definition: A drug given to a patient to mitigate or cure an illness, injury, or reduced health status. See also drug, treatment, intervention.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "drug", "definition": "CDISC Definition: An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)]. See also medicinal product, active substance.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "dynamic HTML", "definition": "CDISC Definition: Collective term for a combination of tags and options, style sheets, and programming that allows users to create web pages in hypertext Mark-up language (HTML) that are more responsive to user interaction than previous versions of HTML.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Early Phase I", "definition": "CDISC Definition: Originally described as an exploratory study with no safety or efficacy targets. It is not cited in current FDA guidance and no longer in common usage. See also phase.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "early termination of trial", "definition": "CDISC Definition: The premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with. [REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC; ICH E6] See also termination (of a clinical trial).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eCertified copy", "definition": "CDISC Definition: A copy of an electronic record that is created through the application of a process validated to preserve the data and metadata of the original and where the validation of the process is certified by the dated signature of an authorized person. [CDISC, after EMA/INS/GCP/454280/2010 GCP Inspectors Working Group (GCP IWG) June 2010]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eClinical trial", "definition": "CDISC Definition: Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. See also clinical study, clinical trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eConsent form", "definition": "CDISC Definition: An electronic document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian. [NCI] See also informed consent, consent form, electronic signature.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eCRF (electronic case report form)", "definition": "CDISC Definition: An auditable electronic record of information that is reported to the sponsor (or sponsor's agent such as an EDC provider) on each trial subject to enable data pertaining to a clinical investigation protocol to be systematically captured, reviewed, managed, stored, analyzed, and reported. The eCRF is a CRF in which related data items and their associated comments, notes, and signatures are linked programmatically. See also case report form, CRF, eSRF.[CSUICI; Revised from FDA Final Guidance on eSource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eCRT (electronic case report tabulation)", "definition": "CDISC Definition: Case report tabulation (CRT) provided in electronic format for eSubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. SDTM is the preferred format.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EDC (electronic data capture)", "definition": "CDISC Definition: The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018] See also data entry, direct data entry, data acquisition, data capture.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "edit check", "definition": "CDISC Definition: An auditable process, usually automated, of assessing the content of a data field against its expected logical, format, range, or other properties that is intended to reduce error. NOTE: Time-of-entry edit checks are a type of edit check that is run (executed) at the time data are first captured or transcribed to an electronic device at the time entry is completed of each field or group of fields on a form. Back-end edit checks are a type that is run against data that has been entered or captured electronically and has also been received by a centralized data store.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EDR (electronic document room)", "definition": "CDISC Definition: The electronic document room is an extension of the e-Submissions central document room. A check is performed on each submission sent to the EDR for file formats used and the integrity of bookmarks and hypertext links.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "effect size", "definition": "CDISC Definition: A measure or estimate of the observed or expected change in an outcome as a result of an intervention. [After AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "effectiveness", "definition": "CDISC Definition: A measure of intended effect on the disease or condition based on regulatory determination made on the basis of clinical efficacy and other substantial evidence, including real-world observations. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also efficacy.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "efficacy", "definition": "CDISC Definition: A measure of intended effect on the disease or condition based on adequate and well-controlled clinical trials. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also effectiveness.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EHR (electronic health record)", "definition": "CDISC Definition: An electronic record for healthcare providers to create, import, store, and use clinical information for patient care, according to nationally recognized interoperability standards. NOTE: The EHR has the following distinguishing features: able to be obtained from multiple sources; shareable; interoperable; accessible to authorized parties. [After National Office of Health Information Technology-HIT, USHHS]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "electronic data transfer", "definition": "CDISC Definition: The exchange of data across computer systems and networks, taking into account all required quality aspects such as security, data privacy, data quality, data integrity, and audit trail. [After FDA 21 CFR Part 11; After Guideline on computerized systems and electronic data in clinical trials (europa.eu) EMA/INS/GCP/112288/2023] See also data security, data quality, data integrity, data entry, ALCOA++.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "electronic personal health record (ePHR)", "definition": "CDISC Definition: An electronic record for individuals to create, import, store, and use clinical information to support their own health.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "electronic record", "definition": "CDISC Definition: Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. [21 CFR 11.3(b) (6)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "electronic signature", "definition": "CDISC Definition: A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUICI; 21 CFR 11.3(7); After US FDA Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application, Aug 2003] See also eConsent form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eligibility criteria", "definition": "CDISC Definition: Requirements that must be met for a person to be included in a study, which help make sure that the results of the study are caused by the intervention being tested and not by other factors. NOTE: Eligibility Criteria, including inclusion and exclusion criteria, should enable constitution of the targeted cohorts in the clinical study. [After NCI's Dictionary of Cancer Terms]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "emergency use authorization", "definition": "CDISC Definition: Approval by FDA for the emergency use of certain unapproved medical products or an unapproved use of an approved medical product for certain emergency circumstances, when applied for under a declared health emergency. These medical products may be referred to as medical countermeasures (MCMs) and may include drugs, biologics, and devices. [After Emergency Use Authorization of Medical Products and Related Authorities. FDA Guidance for Industry and Other Stakeholders. January 2017.] See also pre-approval access.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "EMR (electronic medical record)", "definition": "CDISC Definition: An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs (or EHRs) may serve as source documents, and such data could serve also as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements (e.g., 21 CFR 11). [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "end-point assessment medicinal product", "definition": "CDISC Definition: Medicinal products given to the subject as an aid to assess a relevant clinical trial end-point; it is not being tested or used as a reference in the clinical trial. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "endemic disease", "definition": "CDISC Definition: The constant presence of a disease or infectious agent within a given geographic area or population group; may also refer to the usual prevalence of a given disease within such area or group. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "endpoint", "definition": "CDISC Definition: A defined variable intended to reflect an outcome of interest to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. Primary endpoints are usually statistically analyzed. [After BEST Resource] See also outcome, variable, surrogate endpoint.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "enrolled", "definition": "CDISC Definition: Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting eligibility criteria as specified in the protocol. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. A less common definition confers enrolled status at the signing of an informed consent form, e.g., Clinicaltrials.gov. See also informed consent, enrollment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "enrollment (cumulative)", "definition": "CDISC Definition: Current enrollment including any subjects who were once enrolled and have ended participation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "enrollment (current)", "definition": "CDISC Definition: Subjects actively continuing to participate in a clinical trial as of the current date.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "enrollment", "definition": "CDISC Definition: The action of enrolling one or more subjects. NOTE: The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. [After Glossary Of Terms On Clinical Trials For Patient Engagement Advisory Committee Meeting] See also enrolled.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "epidemic", "definition": "CDISC Definition: The occurrence in a community or region of cases of an illness, specific health-related behavior, or other health-related events clearly in excess of normal expectancy. NOTE: The community or region and the period in which the cases occur are specified precisely. The number of cases indicating the presence of an epidemic varies according to the agent, size, and type of population exposed; previous experience or lack of exposure to the disease; and time and place of occurrence. [After A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, OXFORD UNIVERSITY PRESS 2001]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "epoch", "definition": "CDISC Definition: Planned interval of time in the conduct of a study wherein an activity is specified and consistent, e.g., specific treatment dose or study activity such as Screening. NOTE: A CDISC variable used in the SDTM model to indicate a time period defined in the protocol with a study-specific purpose. See also arm, visit, phase (within a study).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ePRO", "definition": "CDISC Definition: Patient reported outcome data initially captured electronically. NOTE: Usually ePRO data is captured as eSource. [DIA ePRO Working Group]. See also patient reported outcome, PRO, eSource.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "equipoise", "definition": "CDISC Definition: A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. NOTE: An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "equivalence trial", "definition": "CDISC Definition: A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically unimportant. NOTE: This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "equivalent effect", "definition": "CDISC Definition: An effect of two or more bioactive compounds or drugs that is deemed to be equal, and can be expected to have the same clinical effect and safety profile. [After US FDA, Evaluation of Therapeutic Equivalence, Draft Guidance for Industry, July 2022]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eSource data", "definition": "CDISC Definition: Source data captured initially into a permanent electronic record (eSource document) used for the reconstruction and evaluation of a clinical study or a source data item included in an eCRF when direct entry is made. NOTE: permanent in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail. See also eSource document, source data, permanent data, data originator. [From body of FDA Final Guidance on eSource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eSource document", "definition": "CDISC Definition: Electronic record containing source data for a clinical trial, used to aggregate a particular instance of eSource data items for capture, transmission, storage, and/ or display, and serving as a source document for a clinical investigation. NOTE: Electronic Source documents are recorded in electronic systems according to conventions (such as those for PDF documents) that ensure that all the fields of eSource data and associated contextual information (e.g. time of capture, time zone, authorship, origin, signatures, revisions, etc.) are linked to each other in a particular structure for presentation. The encoded specifications in the electronic record thus serve the same role as have the physical properties of paper (binding data items together). eSource documents are subject to regulations and guidance that apply to source documents. See also source documents. [relevant to FDA Final Guidance on eSource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eSource", "definition": "CDISC Definition: Source record that is electronic. See also source, electronic record.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eSRF (electronic source report form)", "definition": "CDISC Definition: The human-readable rendering of an electronic record serving as an eSource document that is part of a case history. The eSRF supports capture, transmission, storage, editing and/ or display of eSource documents (original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation) used for reconstructing and evaluating the investigation. NOTE: Intended use distinguishes eCRF and eSRF. The eCRF is for capture, review and editing of protocol data belonging to the sponsor; the eSRF is for the human-readable representation of the eSource document for review or to maintain the eSource document that is part of the case history under 21CFR312.62. See also eCRF, eSource document. [CDISC, relevant to FDA Final Guidance on eSource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "essential documents", "definition": "CDISC Definition: Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "established name", "definition": "CDISC Definition: The official name of a drug or pharmaceutical product, relevant in US regulations. [US FDA, 21 CFR 299.4] See also proprietary name, generic name, international nonproprietary name (INN), medicinal product name, compendial name.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "estimand", "definition": "CDISC Definition: A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarizes at a population level what the outcomes would be in the same patients under different treatment conditions being compared. NOTE: The four characteristics of an estimand include the definition of the target study population, statement of the endpoint of interest, intercurrent event details, and the population level summary of the variable of interest. (ICH E9 R1 Addendum; After Estimand Framework: What it is and Why You Need it. Applied Clinical Trials. February 27, 2020]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ethics committee", "definition": "CDISC Definition: Group convened to protect research subjects. NOTE: Such bodies, depending on the country or region, are abbreviated as: CCI, CCPPRB, CHR, CPPHS, CRB, EAB, HEX, HSRC, LREC, MREC, NIRB, NRB, and REB. See also institutional review board, independent ethics committee.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ethnicity", "definition": "CDISC Definition: Denotes social groups with a shared history, sense of identity, geography, and cultural roots.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "European Medicines Agency (EMA)", "definition": "CDISC Definition: The regulatory agency for the EU.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "evaluable (for efficacy and safety)", "definition": "CDISC Definition: Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in efficacy/safety datasets.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "event", "definition": "CDISC Definition: Planned protocol activities such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). [After SDTM, www.cdisc.org] See also general observation class, intervention, finding.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exclusion criteria", "definition": "CDISC Definition: List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "excretion", "definition": "CDISC Definition: The act or process of eliminating waste products from the body. See also ADME.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "expansion cohort trial", "definition": "CDISC Definition: A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. NOTE: The objectives of these expansion cohorts can include assessment of antitumor activity in a disease-specific setting, assessment of a dose with acceptable safety in specific populations (e.g., pediatric or elderly subjects, subjects with organ impairment, subjects with specific tumor types), evaluation of alternative doses or schedules, establishment of dose and schedule for the investigational drug administered with another oncology drug, or evaluation of the predictive value of a potential biomarker. In general, comparison of activity between cohorts is not planned except when a prespecified randomization and analysis plan are part of the protocol design. [FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "experimental intervention", "definition": "CDISC Definition: The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). NOTE: This does not include comparators or placebos. [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224; https://grants.nih.gov/policy/clinical-trials/protocol-template.htm] See also test articles, devices, drug product, combination product, treatment, diagnosis, investigational medicinal product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "experimental unit", "definition": "CDISC Definition: A physical entity which is the primary interest in a specific research objective. NOTE: Depending on the research objectives, a single study may have multiple levels of experimental units. Commonly the individual study subject (animal, person or product) is the experimental unit. (BRIDG v5.3)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exploratory IND study", "definition": "CDISC Definition: A clinical study that is conducted early in Phase 1; involves very limited human exposure and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [FDA Guidance for industry, investigators, and Reviewers: exploratory IND studies, January 2006] See also Phase 0.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exploratory objective", "definition": "CDISC Definition: Additional scientific question(s) within the study that enable further discovery research, beyond the primary and secondary objectives. See also objective, primary objective, secondary objective.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exploratory study", "definition": "CDISC Definition: Phase 1 or 2 study during which the actions of a therapeutic intervention are assessed and measured. NOTE: Procedures in exploratory studies may appropriately be altered beyond the standard adequate and well controlled processes to expand the scope or method of investigation. [NOTE: After FDA eCOA Glossary] Compare to confirmatory study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exposure (individual)", "definition": "CDISC Definition: The result of an intentional contact (e.g., intervention, dosage, drug/product use, misuse, or abuse) or an unintentional contact (circumstantial events leading to unknown, inadvertent, or accidental contact) resulting in inputs to the body of an individual which can occur directly through primary bodily contact routes or indirectly through secondary contact routes (such as via fluids as in fetal exposure during pregnancy or lactation/breast feeding or other biological transfers). [After FDA, Reviewer Guidance Evaluating the Risks of Drug Exposure in Human Pregnancies] See also exposure, intervention, extent of exposure.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "exposure", "definition": "CDISC Definition: Contact between an agent and a target. A state of contact or close proximity to a medicinal product, chemical, pathogen, radioisotope or other substance. NOTE: Types of exposure may be described by many qualifiers (e.g., local, systemic, acute, chronic, cumulative, environmental, population, individual, gestational, or occupational.) See also exposure (individual), intervention, extent of exposure. [After International Programme on Chemical Safety (IPCS) 2004 WHO]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "eXtensible markup language (XML) data element", "definition": "CDISC Definition: For XML, an item of data provided in a mark-up mode to allow machine processing. NOTE: The mark-up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019] See also XML (eXtensible Markup Language), Define-XML.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "extent of exposure", "definition": "CDISC Definition: A variable of exposure taking into consideration the strength, dose, duration, frequency, route, and/or timing or gestational stage in utero and other factors. NOTE: Measures of concentrations in biological fluids and tissues may be used to attempt to quantify the extent of exposures (e.g., Cmax, Cmin, Css, AUC in pharmacokinetics or other exposure measurement and assessment models). [After, FDA Guidance for Industry Exposure-Response Relationships] See also exposure, exposure (individual), intervention.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "extraction transformation load (ETL)", "definition": "CDISC Definition: A class of software applications for data extraction, transformation, and loading that are used to implement data interfaces between disparate database systems, often to populate data warehouses.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "feels", "definition": "CDISC Definition: A patient's physical sensation (e.g., symptoms) or perceived mental state. A patient may feel pain, feel feverish, or perceive a severely low mood (as with depression). [FDA Clinical Outcome Assessment (COA) Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "field", "definition": "CDISC Definition: Locus on a data collection instrument (usually a CRF) for recording or displaying a data element. See data item.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "File Transfer Protocol (FTP)", "definition": "CDISC Definition: A standard protocol for exchanging files between computers on the internet. See also TCP/IP.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "final report", "definition": "CDISC Definition: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. [ICH E3]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "finding", "definition": "CDISC Definition: A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis. See also general observation class, intervention, event.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "first subject in - date, time (FSI - date, time)", "definition": "CDISC Definition: The date and/or date and time the first subject is enrolled into a study. See also enrollment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "first subject in - identity (FSI - identity)", "definition": "CDISC Definition: The first subject enrolled. See also enrollment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "first subject screened - date, time", "definition": "CDISC Definition: The date and/or date and time the first subject signs the informed consent form and is screened for potential enrollment or randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "first subject screened - identity", "definition": "CDISC Definition: The first subject who is so screened.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "first subject treated - date, time", "definition": "CDISC Definition: The date and/or date and time when the first subject receives the test article or placebo in a clinical investigation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "first subject treated - identity", "definition": "CDISC Definition: The first subject who is so treated.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "first-in-humans study", "definition": "CDISC Definition: The first Phase 1 study in which the test product is administered to human beings.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "follow-up (clinical study)", "definition": "CDISC Definition: A period in a clinical study during which selected observations are made, starting after the end of the active part of the study or as specified in the protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Food and Drug Administration (FDA)", "definition": "CDISC Definition: The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Form", "definition": "CDISC Definition: A collection of items and item groups for capturing and displaying clinical trial data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "frequentist methods", "definition": "CDISC Definition: Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "frozen", "definition": "CDISC Definition: Status of a database, file, or element that has been presumed to be in its final state pending \"lock\" and where further editing is prevented without \"unfreezing.\" NOTE: Freezing and unfreezing are usually formalized in audit trails and differ from \"locking\" and \"unlocking\" only in the degree of approval required. See database lock.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "functional roles (in a study)", "definition": "CDISC Definition: The function or responsibility assumed by a person in the context of a clinical study. Examples include data manager, investigator. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "functions", "definition": "CDISC Definition: The manner in which a patient can perform successfully tasks and roles required for everyday living. A patient's ability to perform specified activities that are a meaningful (to the patient), part of typical (e.g., daily) life. [FDA Clinical Outcome Assessment (COA) Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "gender", "definition": "CDISC Definition: Subject self-identification re: masculine/feminine. [IOM] See also sex. [The NCI Thesaurus contains biomedical terminologies that NCI does not own or control. This concept contains gender-related content that does not comply with Executive Order 14168.]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "gene therapy", "definition": "CDISC Definition: Ex vivo or in vivo gene modification of cells in order to correct or treat an inherited or acquired disease or condition. NOTE: Gene therapy mechanisms can include: Replacing a disease-causing gene with a healthy copy of the gene; Inactivating a disease-causing gene that is not functioning properly; and Introducing a new or modified gene into the body to help treat a disease. [After Natalie Mount, et al. Cell-based therapy technology classifications and translational challenge. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19; 370(1680): 20150017; After What is Gene Therapy?, US FDA, 07/25/2018] See also cell therapy, regenerative medicine therapy, regenerative medicine advanced therapy, biological product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "general observation class", "definition": "CDISC Definition: In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level observation domains. NOTE: Most CDISC domains are assigned to one of three general observation classes: 1) The Interventions general observation class is a domain that captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (usually for therapeutic purposes) either as specified by the study protocol (e.g., exposure), coincident with the study assessment period (e.g., concomitant medications), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine). 2) The Events general observation class captures occurrences or incidents independent of planned study evaluations occurring during the trial (e.g., \"adverse events\" or \"disposition\") or prior to the trial (e.g., \"medical history\"). 3) The Findings general observation class captures the observations resulting from planned evaluations such as observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, event, intervention, finding. Compare with special purpose domain.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "generalizability", "definition": "CDISC Definition: The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Generative AI (GenAI)", "definition": "CDISC Definition: Algorithms to organize large, complex data sets into meaningful clusters of information in order to create new content, including text, images and audio, in response to a query or prompt. [George Lawton, \"What is GenAI? Generative AI explained\", Informa, Mar 13, 2025, https://www.techtarget.com/searchenterpriseai/definition/generative-AI] See also AI prompt, Large Language Model (LLM).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "generic name", "definition": "CDISC Definition: The name of a drug based on its chemical and molecular structure. NOTE: In the United States of America, this is assigned by the United States Adopted Names (USAN) council. [After Merck Manual, Consumer Version, 2023] See also proprietary name, international nonproprietary name (INN), established name, medicinal product name, compendial name.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "global assessment variable", "definition": "CDISC Definition: A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "glossary", "definition": "CDISC Definition: A collection of specialized words or terms with their meanings.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Good Clinical Practice (GCP)", "definition": "CDISC Definition: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. NOTE: For Guidance on Good Clinical Practice see COMP/ICH/135/95; Declaration of Helsinki; 21 CFR 50, 21 CFR 54, 21 CFR 56, and 21 CFR 312. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "granularity", "definition": "CDISC Definition: Refers to the size of an information unit in relation to a whole. NOTE: Structuring \"privileges\" in electronic systems is said to be highly granular when each of many roles can differ in their capacity to act on electronic records.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "group sequential design", "definition": "CDISC Definition: A type of adaptive trial design that allows successive, unscheduled interim analyses of the data at particular time points or after a pre-defined number of patients have been enrolled. NOTE: This kind of trial design is chosen to allow for spontaneous interim analyses, in order to, for example, determine whether to stop the trial, adjust the sample size, adjust the dose, or otherwise amend the protocol. [After https://toolbox.eupati.eu/glossary/group-sequential-design/; https://www.statisticshowto.com/group-sequential-design/; https://toolkit.ncats.nih.gov/glossary/group-sequential-trial/] See also interim analysis(es), adaptive design, Bayesian statistics, Bayesian approaches.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "handwritten signature", "definition": "CDISC Definition: The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. NOTE: The act of signing with a writing or marking instrument such as a pen or stylus is preserved. [21CFR 11]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "harmonized standard", "definition": "CDISC Definition: A European Norm (EN) that has been accepted by all Member States and has been published in the Official Journal of the European Communities (OJEC).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "hazard ratio", "definition": "CDISC Definition: A complex statistical analysis that compares the risk of harm in one group to another. NOTE: Calculated from the Cox Proportional Hazard model. [After AMA Manual of Style; After NCI Thesaurus] See also relative risk.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Health Level 7 (HL7)", "definition": "CDISC Definition: An ANSI-accredited Standards Developing Organization (SDO) operating in the healthcare arena. NOTE: Level 7 refers to the highest level of the International Standards Organization's (ISO) communications model for Open Systems Interconnection (OSI), the application level. The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. Level 7 supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations, and, most importantly, data exchange structuring.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "health literacy", "definition": "CDISC Definition: The degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make health decisions. [After The Patient Protection and Affordable Care Act of 2010, Title V; After What is Health Literacy? Oct 23, 2019]. See also plain language writing.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "health-related quality of life (HRQoL)", "definition": "CDISC Definition: A multi-domain concept that represents the patient's general perception of the effect of illness and treatment on physical, psychological, and social aspects of life. NOTE: Claiming a statistical and meaningful improvement in HRQoL implies: (1) that all HRQoL domains that are important to interpreting change in how the clinical trial's population feels or functions as a result of the targeted disease and its treatment were measured; (2) that a general improvement was demonstrated; and (3) that no decrement was demonstrated in any domain. [FDA Clinical Outcome Assessment (COA) Glossary] Compare to quality of life (QoL).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "healthcare facility", "definition": "CDISC Definition: Any public or private entity or agency or medical or dental facility where healthcare services are provided or clinical trials are conducted. [After ICH E6; CIOMS Glossary of ICH terms and definitions]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "healthcare provider", "definition": "CDISC Definition: A person licensed, certified, or otherwise authorized or permitted by law to administer healthcare in the ordinary course of business or practice of a profession, including a healthcare facility. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "healthy volunteer", "definition": "CDISC Definition: A person with no significant health-related issues who agrees to participate as a subject in a clinical study. NOTE: This is often a healthy person in a Phase 1 trial. See also Phase 1. [After Patient Recruitment Healthy Volunteer, NIH Clinical Center, 05/18/2022, Webpage accessed 2023-03-30]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "hereditary", "definition": "CDISC Definition: Transmitted from parent to child by genetic transmission. [After NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HIE (Health Information Exchange)", "definition": "CDISC Definition: The mobilization of healthcare information electronically across organizations within a region or community. HIE provides the capability to electronically move clinical information between disparate healthcare information systems, while maintaining the meaning of the information being exchanged. The goal of HIE is to facilitate access to, and retrieval of, clinical data to provide safer, more timely, efficient, effective, equitable, and patient-centered care. [HITSP]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "human subject", "definition": "CDISC Definition: Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3]. See also clinical research subject.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Huriet Law", "definition": "CDISC Definition: France's regulations covering the initiation and conduct of clinical trials.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "HyperText Markup Language (HTML)", "definition": "CDISC Definition: A specification of the W3C that provides markup of documents for display in a web browser. [HL7] Contrast to XML.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "hypertext", "definition": "CDISC Definition: Links in a document that permit browsers to jump immediately to another document. NOTE: In most browsers links are displayed as colored, underlined text.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "hypothesis to test", "definition": "CDISC Definition: In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value. [CONSORT Statement]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "immediately life-threatening disease or condition", "definition": "CDISC Definition: A stage of disease in which there is reasonable likelihood that death will occur within a matter of months, or in which premature death is likely without early treatment. [21 CFR 312.300]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "immune system", "definition": "CDISC Definition: A complex network of cells, chemicals, tissues, and organs that defends the body from infection and disease. NOTE: Bone marrow, thymus, lymphatic system, lymph nodes, spleen, and mucous membranes can be involved. [After NCI Thesaurus] See also antigen, antibody, autoimmunity.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "impartial witness", "definition": "CDISC Definition: A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "in vitro diagnostic device", "definition": "CDISC Definition: A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis. (After Regulation (EU) 2017/746; After US FDA 21 CFR 809.3)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "incidence rate", "definition": "CDISC Definition: A proportion calculated as the number of individuals who develop the disease during a period of time divided by the number of persons at risk. [After AMA Style Guide, 10th Edition; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] See also morbidity rate, morbidity, mortality, incidence, prevalence.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "incidence", "definition": "CDISC Definition: The occurrence of new cases of disease, injury, or disability in a defined population over a specified period of time. NOTE: Incidence is most often expressed relative to the total population at risk (i.e., per unit of population). [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to prevalence. See also morbidity rate, morbidity, mortality, incidence rate.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "inclusion criteria", "definition": "CDISC Definition: The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "independent data monitoring committee (IDMC)", "definition": "CDISC Definition: A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial. [ICH E9] See also data monitoring committee.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "independent ethics committee (IEC)", "definition": "CDISC Definition: An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [After ICH E6 R2 Glossary] See also institutional review board, ethics committee.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "independent variable", "definition": "CDISC Definition: A variable that is not affected by other variables that the study is trying to understand. Independent variables influence dependent variables. [After AMA Manual of Style] See also dependent variable.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "indication", "definition": "CDISC Definition: The target disease or condition, or its manifestations or symptoms, for which the treatment, prevention, mitigation, cure, or diagnosis is studied or approved. NOTE: In the context of product labeling, the disease indication is usually associated with a population of interest. [After 21 CFR 201.57(c)(2); Wording of therapeutic indication. A Guide for Assessors of Centralised Applications. 21 October 2019, EMA/CHMP/483022/2019. Committee for Medicinal Products for Human Use (CHMP)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "indirect identifier", "definition": "CDISC Definition: Data which in connection with other information can be used to identify an individual with high probability, e.g., age at baseline, race, sex, events, specific findings, etc. NOTE: Two levels of indirect identifier are distinguished. Level 1 - not likely to change over time, is visible, and is available in other sources. Typically it is demographic data such as sex, age at a particular date, country, body mass index (BMI). Level 2 - longitudinal information that is likely to change such as measurements, events, age. See also quasi identifier. [PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "informed consent", "definition": "CDISC Definition: A process that provides the subject with explanations that will help in making decisions about whether to begin or continue participating in a study, after having achieved an understanding of the potential risks and benefits. NOTE: Informed consent is an ongoing, interactive process rather than a one-time information session and can use digital methodologies. Under 21 CFR 50.20, no informed consent form may include any \"language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.\" In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. [US FDA 21 CFR 50.20; After US FDA Use of Electronic Informed Consent Questions and Answers Guidance for Institutional Review Boards, Investigators, and Sponsors, Dec 2016] See also consent form, eConsent form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "infusion", "definition": "CDISC Definition: Any form of treatment that is introduced into the body slowly by constant administration or drip via a blood vessel, a muscle, or the spinal cord. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also administration (substance).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ingredient", "definition": "CDISC Definition: Active and/or inactive material used in pharmaceutical product. [After ISO 11615:2017, 3.1.28]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "inspection", "definition": "CDISC Definition: The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). [ICH] See also audit.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "institutional review board (IRB)", "definition": "CDISC Definition: An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. [ICH E6 1.31]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "instrument", "definition": "CDISC Definition: A means to capture data (e.g., questionnaire, diary) plus all the information and documentation that supports its use. NOTE: Generally, instruments include clearly defined methods and instructions for administration or responding, a standard format for data collection, and well-documented methods for scoring, analysis, and interpretation of results. [from PRO Draft Guidance] Compare to questionnaire, survey (see Comments on Draft PRO Guidance, April 4, 2006, by ISOQOL, p. 8).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "intended use", "definition": "CDISC Definition: The specific clinical circumstance or purpose for which a medical product or test is being developed. NOTE: In the regulatory context, this term refers to the \"Statement of Intended Use\" prepared by the persons legally responsible for the labeling of medical products. [after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "intention-to-treat", "definition": "CDISC Definition: The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment given. NOTE: This has the consequence that subjects allocated to a treatment group should be followed up, assessed, and analyzed as members of that group irrespective of their compliance with the planned course of treatment. The principle is intended to prevent bias caused by loss of participants that may reflect non-adherence to the protocol and disrupt baseline equivalence established by random assignment. [ICH E9; after CONSORT statement]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "inter-rater reliability", "definition": "CDISC Definition: The property of scales yielding equivalent results when used by different raters on different occasions. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "intercurrent event", "definition": "CDISC Definition: An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. [ICH E9 Addendum on Estimands]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "interim analysis schedule", "definition": "CDISC Definition: The time/information points at which interim analyses are planned.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "interim analysis(es)", "definition": "CDISC Definition: Analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete. [CONSORT statement]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "interim clinical trial/study report", "definition": "CDISC Definition: A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "internal consistency", "definition": "CDISC Definition: Pertaining to data that do not include contradictions.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "international birth date (IBD)", "definition": "CDISC Definition: The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "international nonproprietary name (INN)", "definition": "CDISC Definition: Unique name for a drug substance (pharmaceutical ingredient) that is globally recognized and public property. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO, Health products policy and standards, INN and medicines classification] See also proprietary name, generic name, established name, medicinal product name, compendial name, active substance.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "internet service provider (ISP)", "definition": "CDISC Definition: A company that provides access to the internet for individuals and organizations.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "internet", "definition": "CDISC Definition: A global system of computer networks that provides the common TCP IP infrastructure for e-mail, the World Wide Web, and other online activities.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "interoperability", "definition": "CDISC Definition: Ability of two or more systems or components to exchange information and to use the information that has been exchanged. [IEEE Standard Computer Dictionary]. See also syntactic, semantic, semantic interoperability.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "intervention", "definition": "CDISC Definition: An activity that produces an effect, or that is intended to alter the course of a disease in a patient or population. This is a general term that encompasses the medical, social, behavioral, and environmental acts that can have preventive, therapeutic, or palliative effects. (NCI) See also investigational product, experimental intervention, vaccine, medical device, diagnostic device.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Investigational Device Exemption (IDE)", "definition": "CDISC Definition: An application to FDA for a waiver to test a device in a clinical trial. [After US FDA, 21 CFR Part 812]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigational device", "definition": "CDISC Definition: A device that is assessed in a clinical investigation. [REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] See also investigational product, medical device.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigational medicinal product", "definition": "CDISC Definition: A pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Reference products and placebos are also considered investigational medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP) -- Step 4 (final), 9 November 2016 -- Glossary] See also authorised investigational medicinal product, experimental intervention.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Investigational New Drug (IND) application", "definition": "CDISC Definition: An application to FDA for a waiver to allow the administration of investigational products in a clinical trial. [After US FDA, 21 CFR Part 312]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigational product code", "definition": "CDISC Definition: A symbol or combination of symbols (usually alphanumeric characters) that are assigned by the sponsor to uniquely identify an experimental intervention. [After ICH M11]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigator", "definition": "CDISC Definition: A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. NOTE: For example, under whose immediate direction the test article is administered or dispensed to, or used involving a subject. [21 CFR 50.3, ICH E6] See also sponsor-investigator, site investigator, principal investigator, coordinating investigator, sub-investigator.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigator's brochure", "definition": "CDISC Definition: A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "investigator/institution", "definition": "CDISC Definition: An expression meaning \"the investigator and/or institution, where required by the applicable regulatory requirements\" with respect to the transfer or assignment of responsibilities. [After ICH E6 1.35] See also coordinating investigator, investigator, principal investigator, site investigator, sponsor-investigator, sub-investigator.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "item (PRO)", "definition": "CDISC Definition: An individual question, statement, or task (and its standardized response options) that is evaluated by the patient to address a particular concept. [FDA Clinical Outcome Assessment (COA) Glossary] See also item generation, response option.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "item definition", "definition": "CDISC Definition: Formal specification of the properties of an item or field of data in an eClinical trial. [CDISC ODM, CDISC CDASH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "item generation", "definition": "CDISC Definition: Establishing the content to be covered by the items in a PRO instrument, including generating item wording, evaluating the completeness of item coverage of the concepts of interest, and performing initial assessment of clarity and readability. NOTE: PRO instrument item generation is potentially incomplete without patient involvement. [from ISOQOL comments on PRO Draft Guidance]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "item group definition", "definition": "CDISC Definition: The specification in an eClinical trial of a collection of items often clinically related to each other and useful to consider as an ensemble. NOTE: Item groups are likely to have greater granularity in analysis datasets using SDTM which can, for example, distinguish between different therapy types: study therapy, prior therapy, concomitant therapy, protocol forbidden therapies, rescue therapies. [ODM]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "item", "definition": "CDISC Definition: A representation of a clinical variable, fact, concept, or instruction in a manner suitable for communication, interpretation, or processing by humans or by automated means. NOTE: Items are collected together to form item groups. [CDISC] Compare to data item, item (PRO).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Janus conceptual model", "definition": "CDISC Definition: A logical design for a data warehouse intended to integrate submission data, protocol descriptions, and analysis plans from clinical and animal studies into an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining, and retrospective comparative analysis. [FDA Study Data Standards]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Janus study data repository", "definition": "CDISC Definition: The Janus is a data repository for subject-level clinical and nonclinical study data submitted to FDA as part of a regulatory submission. NOTE: Sometimes written as JANUS, the term is not an acronym. [FDA Study Data Standards]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "label", "definition": "CDISC Definition: Description of a drug product/ device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities. [FDA; SPL]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "labeling (content of)", "definition": "CDISC Definition: All text, tables, and figures in labeling as described in regulations for a specific product (e.g., 21 CFR 201.56 and 201.57 for human prescription drugs; 201.66 for human over-the-counter drugs; 21 CFR 801 for medical devices; and 21 CFR 606.122 for blood products). See also structured product label.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "laboratory (clinical)", "definition": "CDISC Definition: A laboratory providing analyses of samples collected in clinical care or research.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Large Language Model (LLM)", "definition": "CDISC Definition: A type of AI model trained on large text datasets to learn the relationships between words in natural language. NOTE: These models can apply these learned patterns to predict and generate natural language responses to a wide range of inputs or prompts they receive, to conduct tasks like translation, summarization, and question answering. [FDA Digital Health and Artificial Intelligence Glossary - Educational Resource, 09/26/2024] See also AI prompt, generative AI.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "last subject in - date, time (LSI - date, time)", "definition": "CDISC Definition: The date and/or date and time when a last subject to participate in a clinical trial is enrolled.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "last subject in - identity (LSI - identity)", "definition": "CDISC Definition: The last subject enrolled in a clinical trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "last subject last visit - date, time (LSLV - date, time)", "definition": "CDISC Definition: The date and/or date and time when a last subject has reached a planned or achieved milestone representing the completion of the trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "last subject last visit - identity (LSLV - identity)", "definition": "CDISC Definition: The last subject to reach a planned or achieved milestone representing the completion of the trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "legal authentication", "definition": "CDISC Definition: A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "legally acceptable representative", "definition": "CDISC Definition: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. [ICH, E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "life-threatening adverse event/ experience", "definition": "CDISC Definition: Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred (i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death). [FDA 21 CFR 312.32; ICH-E2A]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "long term follow-up (clinical study)", "definition": "CDISC Definition: A period in a clinical study during which selected observations are made over an extended timeframe, starting after the end of the active part of the study. NOTE: LTFU may be a post-study commitment. [After Long Term Follow-up After Administration of Human Gene Therapy Products. FDA Guidance for Industry. JAN 2020] See also follow-up (clinical study).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "longitudinal study", "definition": "CDISC Definition: A prospective observational study designed to monitor health measures of individuals over a defined period of time. NOTE: A well-known example is the Framingham study, which began in 1948. [After clinicaltrials.gov] See also observational study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "low-interventional clinical trial", "definition": "CDISC Definition: A clinical trial which fulfills all of the following conditions: (a) the investigational medicinal products, excluding placebos, are authorized; (b) according to the protocol of the clinical trial, (i) the investigational medicinal products are used in accordance with the terms of the marketing authorization; or (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and (c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned. [REGULATION (EU) No 536/2014 Article 2.2.(3)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "machine learning", "definition": "CDISC Definition: A computing system (inspired by biological neural networks) that learns (progressively improves its ability) to do tasks by considering examples without task-specific programming. NOTE: Machine learning algorithms build a mathematical model based on sample data, known as \"training data\", in order to make predictions or decisions without being explicitly programmed to do so. [After DeepAI Machine Learning Glossary and Terms] See also deep learning, artificial intelligence (AI).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "manufacturer (device)", "definition": "CDISC Definition: Any person or entity who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either (1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture; (2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; (3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or (4) Is the U.S. agent of a foreign manufacturer. [after 21 CFR 803.3, FDA] See also manufacturer (drug).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "manufacturer (drug)", "definition": "CDISC Definition: Any person or entity involved in the processing, packing, or holding of a medicinal product, including packaging and labeling, testing, and quality control. [after 21 CFR 210.3] See also manufacturer (device).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mapping", "definition": "CDISC Definition: In the context of representing or exchanging data, connecting an item or symbol to a code or concept. Compare to translation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "marketing authorization holder", "definition": "CDISC Definition: Organization or person that is permitted to market a medicinal product in a jurisdiction. [After ISO 11615:2017, 3.1.41]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "marketing authorization procedure", "definition": "CDISC Definition: Formal EU procedure applied by a medicines regulatory agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it. [After ISO 11615:2017, 3.1.43]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "marketing authorization", "definition": "CDISC Definition: Authorisation issued from a medicines regulatory agency that allows a Medicinal Product to be placed on the market. [after ISO 11615 2017-10 on Regulated Medicinal Product information]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "marketing support trials", "definition": "CDISC Definition: Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decision-makers the rationale for preferring one therapy over another.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "markup", "definition": "CDISC Definition: Computer-processable annotations within a multimedia document. NOTE: in the context of the HL7 specification, markup syntax is according to the XML specification. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "masking", "definition": "CDISC Definition: The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from the comparator. NOTE: Blinding refers to study participants while masking refers to the study intervention. [After Crisp A. Blinding in pharmaceutical clinical trials: An overview of points to consider. Contemp Clin Trials. 2015;43:155-163.] See also blinding.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "master protocol", "definition": "CDISC Definition: A protocol designed to enable multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. NOTE: The term \"master protocol\" is often used to describe the design of such trials, with terms such as \"umbrella\", \"basket\", or \"platform\" describing specific designs. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022; Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.] See also umbrella trial design, basket trial design, platform trial design, adaptive design.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "matched-pair design", "definition": "CDISC Definition: A type of parallel trial design in which investigators identify pairs of subjects who are 'identical' with respect to relevant factors, then randomize them so that one receives Treatment a and the other Treatment B. See also pairing.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mean", "definition": "CDISC Definition: The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "MedDRA (Medical Dictionary for Regulatory Activities)", "definition": "CDISC Definition: A global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "median", "definition": "CDISC Definition: The middle value in a data set; that is, just as many values are greater than the median and lower than the median value. (With an even number of values, the conventional median is halfway between the two middle values.)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medical countermeasure", "definition": "CDISC Definition: Pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and nonpharmaceutical products, such as ventilators, diagnostic tests, personal protective equipment (PPE), and patient (also general) decontamination materials, that may be used to prevent, mitigate, or treat the adverse health effects from a public health emergency. [After National Health Security Strategy 2019-2022]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medical device", "definition": "CDISC Definition: Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). NOTE: Specific medical purposes include diagnosis; prevention; monitoring; treatment or alleviation of disease; diagnosis; monitoring; treatment; alleviation of or compensation for an injury; investigation; replacement; modification; or support of the anatomy or of a physiological process; supporting or sustaining life, control of conception; disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices; After MHRA Guidance: Medical device stand-alone software including apps]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medical monitor", "definition": "CDISC Definition: A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medical monitoring", "definition": "CDISC Definition: Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose. See also monitoring.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medication error", "definition": "CDISC Definition: Any unintentional error in the prescribing, dispensing or administration of a medicinal product while in the control of the healthcare professional, patient or consumer. [HMA, Guideline on good pharmacovigilance practices (GVP)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medicinal product classification", "definition": "CDISC Definition: Categorisation or grouping of Medicinal Products based on specific properties and according to various classification systems (e.g., UNII-SRS), which may be regional or international. NOTE: The classification system is specified using an appropriate identification system; the applicable controlled term and the controlled term identifier is specified. [after ISO 11615 2017-10 on Regulated Medicinal Product information]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medicinal product identifier", "definition": "CDISC Definition: Unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a jurisdiction. NOTE: proposed by IDMP as a new universal identifier. [After ISO 11615:2017, 3.1.53]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medicinal product name", "definition": "CDISC Definition: Name as authorized by a Medicines Regulatory Agency. NOTE: As a general principle, a marketing authorization is granted to a single Marketing Authorization Holder or sponsor who is responsible for placing a single Medicinal Product on the market. The marketing authorization contains the name of the Medicinal Product, which can refer to, for example, a single invented name or a scientific name [when available, the INN of the active substance(s)] accompanied by a trademark or other characteristics. Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc. [After ISO 11615:2017, 3.1.54] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "medicinal product", "definition": "CDISC Definition: Any substance or combination of substances that may be administered to human beings (or animals) for treating or preventing disease, or with the intent to make a medical diagnosis or to restore, correct or modify physiological functions. NOTE: 1. A Medicinal Product may contain one or more manufactured items and one or more pharmaceutical products. 2. In certain jurisdictions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis. [After IDMP]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Medicines and Healthcare products Regulatory agency (MHRA)", "definition": "CDISC Definition: The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. [MHRA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mega-trials", "definition": "CDISC Definition: Massive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "memorandum of understanding (MOU)", "definition": "CDISC Definition: A formal agreement between the Food and Drug administration (FDA) and federal, state, or local government agencies; academic institutions; and other entities. NOTE: The MOU constitutes an understanding between the parties but is a non-binding agreement. it is FDA's policy to enter into MOUs with other entities whenever there is a need to define lines of authority or responsibility, or to clarify cooperative procedures.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "message (HL7)", "definition": "CDISC Definition: The atomic unit of data transferred between systems. It comprises a group of segments in a defined sequence, each message has a message type that defines its purpose. NOTE: For example, the Admission, Discharge and Transfer (ADT) Message type is used to transmit portions of a patient's ADT data from one system to another. in HL7, a three-character code contained within each message identifies its type. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "meta-analysis protocol", "definition": "CDISC Definition: The document describing the plan for combining of evidence from relevant studies using appropriate statistical methods to allow inference to be made to the population of interest. NOTE: The most common reason for performing a meta-analysis is to provide an estimate of a treatment effect or measure of relative risk associated with an intervention and to quantify the uncertainty about the estimated effect or risk, when data from a single existing study are insufficient for this purpose. [FDA Draft Guidance, Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry, November 2018] See also meta-analysis.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "meta-analysis", "definition": "CDISC Definition: The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. NOTE: This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data. The methodology for performing the meta-analysis can be found in a meta-analysis protocol, or plan. [After ICH E9 Glossary] See also meta-analysis protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "metabolism", "definition": "CDISC Definition: The biochemical alteration of substances introduced into the body.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "metadata", "definition": "CDISC Definition: Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "migration", "definition": "CDISC Definition: The act of moving a system or software product (including data) from an old to new operational environment in accordance with a software quality system. ISO/IEC/IEEE 12207:1995 5.5.5]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "minor", "definition": "CDISC Definition: A subject who, according to the law of the applicable jurisdiction concerned, is under the age of legal competence to give informed consent. [after EU CTR]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "missing data", "definition": "CDISC Definition: Data not completed or corrupted in reports and case report forms, e.g., the data not captured when a subject withdraws from a trial. NOTE: Reviewers are concerned about missing data since patients who are not improved or who believe they have experienced side effects may be particularly prone to leave a trial, thus skewing the analysis of results if such analysis were to be done only on the subjects who had continued with the trial. Trial designs therefore specify plans for how such missing data will be treated in analysis. See also intention to treat. [FDA Guidance on Subject Withdrawal, 2008]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mode", "definition": "CDISC Definition: The most frequently occurring value in a data set.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "model", "definition": "CDISC Definition: A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context (e.g., clinical trial data). [CDISC]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "modem", "definition": "CDISC Definition: From modulator/ demodulator; a device that converts digital data into analog data that can be transmitted via telephone or cable lines used for communications.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "moiety", "definition": "CDISC Definition: An entity that has a complete and continuous molecular structure and is part of a substance. The active moiety of the molecule is the basis for the physiological or pharmacological action of the drug substance. NOTE: The strength of a pharmaceutical product is often based on what is referred to as the active moiety. [after ISO 11238 2012-11 on Regulated information on Substances]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "monitor", "definition": "CDISC Definition: Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol and GCP guidance. NOTE: A monitor's duties may include, but are not limited to, helping to plan and initiate a trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial. [from ICH E6, 5.18] See also clinical research associate.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "monitoring plan", "definition": "CDISC Definition: A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. [ICH E6(R2) Glossary Addendum] See also monitoring.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "monitoring report", "definition": "CDISC Definition: A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "monitoring visit", "definition": "CDISC Definition: A visit to a study site to review the progress of a clinical study and to ensure protocol adherence, accuracy of data, safety of subjects, and compliance with regulatory requirements and good clinical practice guidelines. [from ICH E6, 5.18]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "monitoring", "definition": "CDISC Definition: Act of overseeing, tracking, observing, evaluating or supervising over time by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring, data monitoring, risk based monitoring.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "morbidity rate", "definition": "CDISC Definition: A measure of the frequency of occurrence of a specific disease, injury, or disability in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, incidence, prevalence, mortality rate, incidence rate.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "morbidity", "definition": "CDISC Definition: Departure from physiological or psychological health, i.e., disease, injury, or disability. NOTE: Most often measures of morbidity frequency characterize the number of persons in a population who become ill (incidence) or are ill at a given time (prevalence). See also morbidity rate, incidence, prevalence, mortality rate, incidence rate, virulence.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mortality rate", "definition": "CDISC Definition: A measure of the frequency of occurrence of death in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, morbidity rate, incidence, prevalence, incidence rate.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "multicenter trial", "definition": "CDISC Definition: Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/institution, study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "mutual recognition procedure (MRP)", "definition": "CDISC Definition: The EU procedure to be used when a product is already authorized in at least one Member State and the Marketing Authorization Holder wishes to obtain a Marketing Authorization (MA) for the same product in at least one other Member State. The Member State that has already authorized the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member State/s (CMS). If the applicant is successful, the CMS will then issue a MA for that product permitting the marketing of that product in their country. [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html] See also Reference Member State (RMS) and Concerned Member State (CMS).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "n-of-1 study", "definition": "CDISC Definition: A trial in which an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment's effect in that person, often with the order of experimental and control treatments randomized.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "natural language processing", "definition": "CDISC Definition: The use of algorithms to determine properties of natural, human language so that computers can understand what humans have written or said. NLP includes teaching computer systems how to extract data from bodies of written text, translate from one language to another, and recognize printed or handwritten words. NOTE: NLP is the field that allows for our everyday use of virtual assistants such as Siri, Alexa, or Google. [After DeepAI Definitions] See also artificial intelligence (AI).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "natural language", "definition": "CDISC Definition: Language as used in ordinary communications among humans and distinguished from controlled terminologies and structured languages used exclusively for communication and interoperability among machines.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NCI Enterprise Vocabulary Services (EVS)", "definition": "CDISC Definition: A US national resource to house and maintain a number of health-related glossaries and controlled vocabularies under strict versioning. Provides resources and services to meet the National Cancer Institute's needs for controlled terminology, and to facilitate the standardization of terminology and information systems across the NCI and the larger biomedical community.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "negative test result", "definition": "CDISC Definition: The finding of the test indicates the criteria for the condition tested were not met. NOTE: The test condition and the applied criteria are dependent on the specific case, as defined in the test design. The test results must be validated by comparison to a recognized reference standard.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "neoadjuvant therapy", "definition": "CDISC Definition: Therapy administered prior to the primary treatment for the purpose of making the primary treatment more effective. [After NCI Thesaurus] See also adjuvant therapy, treatment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "neural network", "definition": "CDISC Definition: A computational model inspired by the structure of the human brain. It is composed of interconnected nodes, or \"neurons\" organized into layers: an input layer that receives data, one or more hidden layers that process and identify patterns in the data, and an output layer that presents the final network output. [FDA Digital Health and Artificial Intelligence Glossary - Educational Resource, 09/26/2024] See also machine learning, deep learning, artificial intelligence.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "new chemical entity (NCE)", "definition": "CDISC Definition: A drug that contains no active moiety that has been approved by the US FDA. [US FDA (CDER) guidance, New Chemical Entity Exclusivity Determinations for Certain Fixed Combination Drug Products Guidance for Industry, October 2014]. See also new molecular entity (NME), moiety.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "New Drug Application (NDA)", "definition": "CDISC Definition: An application to FDA for a license to market a new drug in the United States.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "new molecular entity (NME)", "definition": "CDISC Definition: A drug or biologic whose active ingredient contains no active moiety that has been previously approved by the US FDA. NOTE: Certain drugs are classified as new molecular entities (\"NMEs\") for FDA review administrative purposes. [After US FDA. (04/08/2024). Novel Drug Approvals at FDA. Retrieved from URL https://www.fda.gov/drugs/development-approval-process-drugs/novel-drug-approvals-fda#:~:text=Certain%20drugs%20are%20classified%20as%20new%20molecular%20entities,products%20frequently%20provide%20important%20new%20therapies%20for%20patients.%20Webpage%20access%202024/04/18] See also new chemical entity (NCE), moiety.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "new safety information", "definition": "CDISC Definition: Previously unknown safety information derived from: (A) a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; (B) the post-market risk identification and analysis system (REMS); or, (C) other scientific data regarding, (i) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed, or (ii) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "NOEL (no observable effect level)", "definition": "CDISC Definition: The dose of an experimental drug given preclinically that does not produce an observable toxicity.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "nomenclature", "definition": "CDISC Definition: Application of naming conventions. Compare to vocabulary, terminology.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "non-confirmatory result", "definition": "CDISC Definition: In a trial, typically phase 3, results that fail to achieve statistical significance and therefore fail to confirm the preliminary evidence from other trials that a drug is safe and effective for use for the intended indication and population. NOTE: Non-confirmatory trial results provide useful scientific information. [After ICH E8] See also confirmatory trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "non-inferiority (NI) trial", "definition": "CDISC Definition: A type of controlled trial to demonstrate that the new treatment is not less effective than the active control by a specified amount. [After Non-Inferiority Clinical Trials to Establish Effectiveness. FDA Guidance for Industry. November 2016]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "non-interventional study", "definition": "CDISC Definition: A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. [Clinical Trial Directive EC/20/2001 definitions]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "nonclinical study", "definition": "CDISC Definition: Biomedical studies not performed on human subjects. [ICH E6 (R2)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "not approvable letter", "definition": "CDISC Definition: An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Notified Body (NB)", "definition": "CDISC Definition: A private institution charged by the Competent Authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "null hypothesis", "definition": "CDISC Definition: The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. NOTE: A null hypothesis (for example, \"subjects will experience no change in blood pressure as a result of administration of the test product\") is used to rule out every possibility except the one the researcher is trying to prove, and is used because most statistical methods are less able to prove something true than to provide strong evidence that it is false. The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. See also research hypothesis. [from AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Nuremberg Code", "definition": "CDISC Definition: A code of ethics set forth in 1947 for the conduct of medical research, with the express purpose of protecting human medical research subjects.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "objective", "definition": "CDISC Definition: The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. [After ICH E8] See also primary objective, secondary objective.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "observation", "definition": "CDISC Definition: An assessment of patient condition in data collected on an individual patient or group of patients. Note: In SDTM, an observation refers to a discrete piece of information collected during a study, e.g., measures used to assess an outcome. [SDTM] See also variable, outcome.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "observational study", "definition": "CDISC Definition: Study in which the researchers observe the effect of a risk factor (e.g., exposure), diagnostic test, treatment or other covariate within a study population, and where the investigator does not assign specific interventions. NOTE: Major subtypes of observational studies are cohort study, case-control study, and cross-sectional study. [After Observational studies: Cohort and Case-Control Studies, JW Song, KC Chung Plast Reconstru Surg, 2010 Dec; After A Dictionary of Epidemiology (5th ed.), Porta M, ed. (2014)., Oxford University Press, New York] See also investigational clinical trials, cohort study, case-control study, cross-sectional study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "observer assessment", "definition": "CDISC Definition: An assessment of patient condition made by an observer (investigator, nurse, clinician, family member, etc.). NOTE: Distinguished from self-assessment. The observer relies on his or her judgment to assess the subject. an interviewer simply capturing subject self assessments is not making an observer assessment. Compare to PRO, proxy assessment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "observer-reported outcome (ObsRO)", "definition": "CDISC Definition: A type of clinical outcome assessment. A measurement based on a report of observable signs, events or behaviors related to a patient's health condition by someone other than the patient or a health professional. [After BEST Resource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "off-label", "definition": "CDISC Definition: Use of a medical product (such as a drug, biologic, or device) that is unapproved in the region of interest. Note: Not approved for the indication or not approved for the conditions mentioned in the approval (e.g., age group of subjects, dosage, or route of administration). [After FDA Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule Sept 2010; After EMA Glossary of Regulatory terms]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "official protocol title", "definition": "CDISC Definition: The formal descriptive name for the protocol that contains key elements of the study. NOTE: The official protocol title should include the study acronym, if applicable [WHO ICTRP]. The official protocol title should be sufficiently different from other protocol titles to create brevity with specificity [After NIH Protocol Template].", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "ontology", "definition": "CDISC Definition: An explicit formal specification of how to represent relationships among objects, concepts, and other entities that belong to a particular domain of experience or knowledge. See also terminology.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "open to enrollment", "definition": "CDISC Definition: The status of a study such that a subject can be enrolled into that study. NOTE: Registry terminology in common use is \"open to recruitment\"; however, recruitment can begin upon IRB approval of the site; whereas enrollment requires availability of study supplies, subject informed consent, etc., to allow participation of eligible subjects.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "open-label study", "definition": "CDISC Definition: A study in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. See blinding.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "operational model", "definition": "CDISC Definition: The set of CDISC data standards (including ODM and LAB) used to capture and archive data from clinical trials.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "opinion (in relation to independent ethics committee)", "definition": "CDISC Definition: The judgment and/or the advice provided by an independent ethics committee. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "original data", "definition": "CDISC Definition: The first recorded study data values. NOTE: FDA is allowing original documents and the original data recorded on those documents to be replaced by copies provided that the copies have been verified as identical in content and meaning. (see FDA Compliance Policy Guide 7150.13). [Modified from CSUICI] See also certified copy, source.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "other serious (important medical events)", "definition": "CDISC Definition: A category of important medical events that may not be immediately life-threatening, result in death, or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes criteria events requiring assessment for potential regulatory reporting as a serious adverse event. Note: These \"Other serious\" events require medical and scientific judgement in evaluating the need for reporting as a serious adverse event. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. [after FDA 310.305, ICH E2A] See also serious adverse event.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outcome (of adverse event)", "definition": "CDISC Definition: Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved, recovering/ resolving, not recovered/not resolved, recovered/resolved with sequelae, fatal, or unknown. [SDTM events class of observation]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outcome measure", "definition": "CDISC Definition: Specific key measurement(s) or observation(s) used to determine the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. (After BRIDG)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outcome of study", "definition": "CDISC Definition: The findings from a research study including data, statistical analyses, and clinical interpretation. [After ICH E3] See also clinical study report, outcome, result synopsis, study results.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outcome", "definition": "CDISC Definition: A measureable characteristic that is influenced or affected by an individual's baseline state or an intervention, as in a clinical trial or other exposure. NOTE: Outcome can be a result of analysis and is more general than endpoint in that it does not necessarily relate to a planned objective of the study outcome (SDTM). [After BEST Resource] See also variable, observation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outcomes research", "definition": "CDISC Definition: Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions. NOTE: Usually distinguished from research conducted solely to determine efficacy and safety. [Guyatt et al., 1993] See also pharmacoeconomics, quality of life.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "outliers", "definition": "CDISC Definition: Values outside of an expected range.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "overdose", "definition": "CDISC Definition: Administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information. [After, EU Guideline on good pharmacovigilance practices (GVP)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "p-value", "definition": "CDISC Definition: The probability that the observed data could have arisen by chance when the interventions did not differ. [After AMA Manual of Style] See also null hypothesis.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "packaging", "definition": "CDISC Definition: The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pairing", "definition": "CDISC Definition: A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B. See also matched-pair design.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "palliative therapy", "definition": "CDISC Definition: Therapy administered to relieve the symptoms and reduce the suffering caused by advanced, progressive disease. [After NCI Thesaurus] See also treatment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pandemic", "definition": "CDISC Definition: An epidemic occurring worldwide, or over a very wide area, crossing international boundaries, and usually affecting a large number of people. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "parallel trial", "definition": "CDISC Definition: A trial design in which subjects are randomised to one of two or more arms, with each arm being allocated a different intervention for the duration of the study. NOTE: These interventions will include the investigational product at one or more doses and one or more controls, such as placebo, an active comparator, or both. [After ICH E9; after NIH National Center for Advancing Translational Sciences, Toolkit for Patients-Focused Therapy Development, Glossary] See also randomized controlled trial (RCT), crossover trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "parameter", "definition": "CDISC Definition: A variable in a model, or a variable that wholly or partially characterizes a probability distribution (mathematics and statistics). NOTE: in clinical trials the term is often used synonymously with 'variable' for factual information (age, date of recovery), measurements, and clinical assessments. it is most appropriately linked to statistical conventions and as a numeric characteristic of a population. Parameters are rarely known and are usually estimated by statistical computation from samples. Thus the term is narrower than variable. [Parexel Barnett; ADaM; HyperStat Online] See also variable, outcome.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "participant", "definition": "CDISC Definition: A person or entity with a role in a clinical study. NOTE: Participants can be human subjects or study personnel. The term \"participant\" is used with growing frequency in some clinical and patient-facing documents like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, study participant.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "password aging", "definition": "CDISC Definition: A practice applying to multi-user computer systems where the validity of a password expires after a certain pre-set period. NOTE: FDA requires that passwords that are part of electronic signatures be \"periodically checked, recalled or revised,\" but does not mandate password aging. [After NIST, 21 CFR 11]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "patient file", "definition": "CDISC Definition: One that contains demographic, medical, and treatment information about a patient or subject. It may be paper- or computer-based or a mixture of computer and paper records.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "patient", "definition": "CDISC Definition: Person under a physician's care for a particular disease or condition. NOTE: A subject in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a subject. Although often used interchangeably as a synonym for subject, a healthy volunteer is not a patient. See also human subject, clinical research subject, healthy volunteer, participant.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "patient-reported outcome (PRO)", "definition": "CDISC Definition: A type of clinical outcome assessment. A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else. NOTE: A PRO can be measured by self-report or by interview provided that the interviewer records only the patient's response. Symptoms or other unobservable concepts known only to the patient can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others. [After BEST Resource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "peer review", "definition": "CDISC Definition: Primarily, the critical assessment by experts (who are usually not part of the editorial staff) of manuscripts submitted to journals. NOTE: Because unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including scientific research, peer review is an important extension of the scientific process. [After ICMJE Recommendations]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "per-protocol analysis set", "definition": "CDISC Definition: The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "performance outcome (PerfO)", "definition": "CDISC Definition: A PerfO is a measurement based on a task(s) performed by a patient according to instructions that is administered by a health care professional. NOTE: Performance outcomes require patient cooperation and motivation. These include measures of gait speed (e.g., timed 25 foot walk test), memory recall, or other cognitive testing (e.g., digit symbol substitution test). [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. After BEST Resource]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "performed activity", "definition": "CDISC Definition: Clinical trial events as they actually occurred (as compared with events planned in the protocol).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "period effect", "definition": "CDISC Definition: An effect occurring during a period of a trial in which subjects are observed and no treatment is administered.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "permanent data", "definition": "CDISC Definition: Data that become or are intended to become part of an electronic record in relation to a regulatory submission. NOTE: Any changes made to such permanent data are recorded via an audit trail so that prior values are not obscured.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "permissible values", "definition": "CDISC Definition: Limited universe of options for data items. (e.g., drop-down menus, codelists, pick lists).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "personal data retention", "definition": "CDISC Definition: The act of maintaining or holding personal data and those obligations on the part of controllers to retain personal data for certain specified purposes. [After European Data Protection Supervisor, Glossary, https://www.edps.europa.eu/data-protection/data-protection/glossary/d_en, Accessed 2025-02-27] See also personal data, processing (personal data), data controller.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "personally identifiable information (PII)", "definition": "CDISC Definition: Any information about an individual maintained by an agency (or group) including but not limited to, education, financial transactions, medical history, and criminal or employment history, which can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, biometric records, etc., including any other personal information that is linked or linkable to an individual. Used in US [NIST Special publication 800-122] See also personal data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmaceutical product", "definition": "CDISC Definition: Qualitative and quantitative composition of a medicinal product in the dose form authorized by the regulatory authority for administration to patients, and as represented with any corresponding regulated product information. NOTE: A medicinal product may contain one or more pharmaceutical products. In many instances, the pharmaceutical product is the manufactured item. However, there are instances where the manufactured item undergoes further preparation before being administered to the patient (as the pharmaceutical product). [After ISO 11615:2017, 3.1.60]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacodynamics", "definition": "CDISC Definition: Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacoeconomics", "definition": "CDISC Definition: Branch of economics that applies cost-benefit, cost-utility, cost-minimization, and cost-effectiveness analyses to assess the utility of different pharmaceutical products or to compare drug therapy to other treatments.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacogenetic test", "definition": "CDISC Definition: An assay intended to study interindividual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacogenetics", "definition": "CDISC Definition: Study of the way drugs interact with genetic makeup or the study of genetic response to a drug.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacogenomic test", "definition": "CDISC Definition: An assay intended to study interindividual variations in whole genome or candidate gene maps, biomarkers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response. Compare to pharmacogenetic test.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacogenomics", "definition": "CDISC Definition: Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to predict whether a person will respond favorably, adversely, or not at all to an investigational product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacokinetics", "definition": "CDISC Definition: Study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of medicinal products.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacology", "definition": "CDISC Definition: Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pharmacovigilance", "definition": "CDISC Definition: Process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. NOTE: Pharmacovigilance is a key public health function that comprises: collecting and managing data on the safety of medicines; looking at the data to detect 'signals' (any new or changing safety issue); evaluating the data and making decisions with regard to safety issues; acting to protect public health (including regulatory action);communicating with stakeholders; auditing of both the outcomes of action taken and the key processes involved. [After IDMP] See also postmarketing surveillance.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase (within a study)", "definition": "CDISC Definition: A stage in the sequence of activities in a clinical study (e.g., Screening, Randomization, Treatment, Follow-up). See also arm, visit, phase (of clinical development), epoch.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 1", "definition": "CDISC Definition: The initial introduction of an investigational new drug into humans. Phase 1 studies are closely monitored and are most often conducted in normal healthy volunteer subjects but in specific cases also in patients. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after ICH E8; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also phase.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 2", "definition": "CDISC Definition: Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 2a", "definition": "CDISC Definition: Early Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] See also phase, phase 2, phase 2b.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 2b", "definition": "CDISC Definition: Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.] See also phase, phase 2, phase 2a.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 3", "definition": "CDISC Definition: Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 3b", "definition": "CDISC Definition: Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. See also phase, phase 3.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 4", "definition": "CDISC Definition: Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase 5", "definition": "CDISC Definition: Postmarketing surveillance to monitor product safety and efficacy. See also outcomes research, phase, postmarketing surveillance.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "phase", "definition": "CDISC Definition: A stage in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also Phase 0-5, epoch (if reference is to a single trial), phase (within a study), clinical research and development.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "placebo", "definition": "CDISC Definition: A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "placebo-controlled study", "definition": "CDISC Definition: A type of study in which a group receiving an experimental treatment is compared with a control group receiving placebo. [After 21 CFR 314.12; After ICH E10] See also placebo.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "plain language writing", "definition": "CDISC Definition: Writing in a way that helps readers understand the content in a document the first time they read it. Note: Plain writing is intended to be clear, concise, well-organized, and follow other best practices appropriate to the topic or field and the intended audience. [After Plain Writing Act of 2010, FDA]. See also health literacy.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "platform trial design", "definition": "CDISC Definition: A type of trial design under a master protocol framework that tests multiple, targeted therapies that may be adapted over the course of the study. NOTE: Platform trials often include an adaptive design that may eliminate or add treatments based on interim analysis. These trials may also include elements of basket or umbrella trials and may have no pre-determined end date. [After Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.; After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol, adaptive design.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "platform trial", "definition": "CDISC Definition: A type of trial conducted under a master protocol and designed to test multiple, targeted therapies that may be adapted over the course of the study. NOTE: Platform trials often include an adaptive design that may eliminate or add treatments based on interim analysis. These trials may also include elements of basket or umbrella trials and may have no pre-determined end date. [After Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.; After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol, adaptive design, platform trial design.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "population", "definition": "CDISC Definition: Any finite or infinite collection of subjects from which a sample is drawn for a study to obtain estimates for values that would be obtained if the entire population were sampled. [AMA style Manual]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "positive test result", "definition": "CDISC Definition: The finding of the test indicates the criteria for the condition tested were met. NOTE: The test condition and the applied criteria are dependent on the specific case, as defined in the test design. The test results must be validated by comparison to a recognized reference standard.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "postmarketing commitment (PMC)", "definition": "CDISC Definition: Studies that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [FDA Webpage Postmarketing Requirements and Commitments: Introduction, 01/12/2016] See also postmarketing requirement. Compare to postmarketing requirement (PMR).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "postmarketing requirement (PMR)", "definition": "CDISC Definition: FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e] Compare to postmarketing commitment (PMC).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "postmarketing surveillance", "definition": "CDISC Definition: Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies, pharmacovigilance.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pragmatic trial", "definition": "CDISC Definition: A trial that compares health interventions in a diverse population representing clinical practice. These trials inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice. NOTE: These trials may or may not be randomized and can be large simple studies. [After GetReal - Project No. 115546l, WP1: Deliverable D1.3, Glossary of Definitions of Common Terms; Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454-63.] See also Real-World Data (RWD), Real-World Evidence (RWE), confirmatory trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pre-approval access", "definition": "CDISC Definition: A potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. NOTE: The intent is treatment, as opposed to research. Individual, Intermediate-size, and Widespread Use Expanded Access, also Emergency IND, are all programs administered under FDA guidelines. Additionally, the US Right-to-Try Act, which is independent of FDA, expands access. [FDA Expanded Access: Information for Physicians]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pre-market approval application (PMA)", "definition": "CDISC Definition: An application to FDA for a license to market a new device in the United States.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "preamble", "definition": "CDISC Definition: A section preceding the text of a final FDA regulation published in the Federal Register. NOTE: \"The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue\" raised in comments submitted in response to the proposed regulation. [After 21CFR10.40]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "preclinical studies", "definition": "CDISC Definition: Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP). NOTE: Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies or trials).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "prevalence", "definition": "CDISC Definition: The number of the existing cases of disease or injury in a defined population at a given point in time. NOTE: The relation between incidence and prevalence varies among diseases. There may be low incidence and a high prevalence - as for diabetes - or a high incidence and a low prevalence - as for the common cold. [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to incidence. See also morbidity rate, morbidity, mortality, incidence rate.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "primary completion date", "definition": "CDISC Definition: The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome [measure], whether the clinical trial concluded according to the pre-specified protocol or was terminated. NOTE: The primary completion date may or may not be the same as the study completion date. [ClinicalTrials.gov]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "primary objective", "definition": "CDISC Definition: The main scientific question(s) the study is designed to answer. [After ICH E8; ICH E6 6.3] See also objective, secondary objective, exploratory objective.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "primary outcome variable", "definition": "CDISC Definition: An outcome variable specified in the protocol to be of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions. [CONSORT Statement] See also primary objective, outcome, endpoint.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "principal investigator", "definition": "CDISC Definition: The study investigator who has the primary responsibility for the conduct of a study and for the study-related personnel at the participating site(s). NOTE: While the term is defined inconsistently within some guidance, in common usage, the term is used as defined above and the accountabilities are assigned by the sponsor. [After ICH E6 and WHO]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "privacy breach", "definition": "CDISC Definition: A privacy breach is the loss of, unauthorized access to, or disclosure of, personal information. [Office of the Privacy Commissioner of Canada] See also serious breach.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "probability", "definition": "CDISC Definition: The number of times an event is expected to occur in a study group divided by the number of individuals being studied. [After AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "processing (personal data)", "definition": "CDISC Definition: Any operation or set of operations that are performed on personal data or on sets of personal data, whether or not by automated means. NOTE: Examples are: collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. [After Article 4 GDPR Definitions] See also personal data, data controller, data processor, subprocessor.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "product dose", "definition": "CDISC Definition: The amount of a product administered in a single dose at a point in time. Usually expressed as a weight, volume, or a number of items (e.g., dosage forms) administered. The expression refers to the substance(s) contained in the Product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "progression-free survival", "definition": "CDISC Definition: The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works. [NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "PROMIS", "definition": "CDISC Definition: NIH-sponsored project for the development and evaluation of PRO item banks and computer adaptive testing for pain, fatigue, physical function, social function, and emotional well-being. [NIH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "prophylaxis", "definition": "CDISC Definition: Practices or interventions used to maintain health and prevent disease or injury. NOTE: Involves limiting the chances of illness, injuries, or reduced health status from occurring (primary prevention) and, when diseases occur, supporting people to manage them as effectively as possible in order to prevent progression or recurrence (secondary prevention). Prevention is achieved by applying vaccines, behavioral changes, life style changes, improved nutrition, etc. [After Prevention is better than cure, UK Department of Health and Social Care, Nov 5th 2018. After Primary, secondary and tertiary prevention, Institute for Work & Health, Toronto April 2015]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "proprietary name", "definition": "CDISC Definition: A commercial name granted by a naming authority for use in marketing a drug/device product. [SPL; FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Guidance for Industry, December 2020] See also generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "prospective study", "definition": "CDISC Definition: A study with planned observations collected predominantly after the start of the study (i.e. forward-looking). Note: Examples are interventional clinical trials, including clinical trials with an adaptive trial design. [After ClinicalTrials.gov] See also retrospective study, interventional clinical trial, observational study, adaptive design, clinical study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protected personal data (PPD)", "definition": "CDISC Definition: Data relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural, or social identity. NOTE: In a clinical trial setting, data refers to collected information. [After EU Directive 95/46/EC] See also processing (personal data), sensitive personal data, data controller, data processor, subprocessor.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol amendment(s)", "definition": "CDISC Definition: A written description of a change(s) to or formal clarification of a protocol. NOTE: If a protocol modification is substantial, it may require notification to the regulatory authority. For example, substantial impacts on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial. [ICH E3; ICH E6 (R2) Glossary 1.45]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol approval (Sponsor)", "definition": "CDISC Definition: Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated. NOTE: Approval by the sponsor usually initiates secondary approvals by IRBs, regulatory authorities, and sites. Protocol amendments usually also require a cycle of approval by sponsor and study staff prior to taking effect.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol deviation", "definition": "CDISC Definition: A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor. NOTE: Good clinical practice recommends that deviations be summarized by site and by category as part of the report of study results so that the possible importance of the deviations to the findings of the study can be assessed. Compare to protocol violation. [See ICH E3]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Protocol Identifying Number", "definition": "CDISC Definition: Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers (National number, coop group number). [EudraCT]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol referenced documents", "definition": "CDISC Definition: Documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [After ICH E6 1.44] See also protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol title", "definition": "CDISC Definition: The name of a study protocol. NOTE: In most cases the protocol title is the same as the study title but in certain cases the titles may be different. See also official protocol title, public protocol title, master protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol violation", "definition": "CDISC Definition: A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per-protocol analysis, and may require that the subject(s) who violate the protocol be discontinued from the study. Compare to protocol deviation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "protocol", "definition": "CDISC Definition: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. [ICH E6 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "proxy (as an origin of outcome measures)", "definition": "CDISC Definition: A proposed standardized qualifier variable to describe the origin of observations of the Findings class resulting from outcomes measures. Proxy describes outcome data furnished by someone other than the patient and distinguishes the origin of the outcome from a self-report (PRO) directly from the patient. NOTE: The term proxy helps qualify outcomes measures that record feelings and symptoms reported by the patient but not recorded directly. [CDISC (extension of SDTM based on Table 2 Patrick, D.L., 2003)] See also observer assessment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "proxy respondent", "definition": "CDISC Definition: Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. [Patrick, D.L., 2003; DIA ePRO Workgroup] Compare to observer assessment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "proxy-reported outcome", "definition": "CDISC Definition: A measurement based on a report by someone other than the patient reporting as if he or she is the patient. NOTE: A proxy-reported outcome is not a patient-reported outcome (PRO). FDA does not consider a proxy-reported outcome as a valid endpoint. [After FDA Clinical Outcome Assessment (COA) Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "pseudonymization", "definition": "CDISC Definition: A privacy preservation technique that both replaces the direct association with a data subject and adds an association between a particular set of characteristics relating to the data subject and one or more pseudonyms. Typically, pseudonymization is implemented by replacing direct identifiers (like the subject's name) with a pseudonym such as a randomly generated value. [ISO/TS 25237:2008]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "psychometric reliability", "definition": "CDISC Definition: The degree to which a psychometric 'instrument' is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time. NOTE: Reliability pertains to questions concerning whether an instrument is accurate, repeatable, and sensitive. Reliability is distinguished from validation, which answers whether the instrument (e.g., questionnaire) actually measure the selected \"construct\" (latent variable). For example a balance (scale) is easily understood as a possibly valid instrument to measure body weight. Its reliability would be assessed by measuring the sensitivity, repeatability, and accuracy of the balance. The validity of using the balance for a particular purpose could then be established by comparing the measured reliability to the reliability required for that purpose. [After Patrick, D.L., 2003] Compare to psychometric validation. See also validation, instrument.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "psychometric validation", "definition": "CDISC Definition: The specialized process of validating questionnaires used in outcomes research to show that they measure what they purport to measure. NOTE: Several types of validity are distinguished. For example, [Guyatt et al., 1993; DIA ePRO Workgroup] See also validation; compare to psychometric reliability.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "psychometrics", "definition": "CDISC Definition: The science of assessing the measurement characteristics of scales that assess human psychological characteristics.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "public protocol title", "definition": "CDISC Definition: The brief descriptive name for the protocol that is intended for the public in easily understood language. NOTE: Public title may also be referred to as a short title or brief title. [Segen's Medical Dictionary] See also official protocol title, protocol title.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "qualitative variable", "definition": "CDISC Definition: One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categories according to their attributes.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "quality assurance (QA)", "definition": "CDISC Definition: All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH E6 R2 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "quality control (QC)", "definition": "CDISC Definition: The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled. [ICH E6 R2 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "quality of life (QoL)", "definition": "CDISC Definition: A broad ranging concept that incorporates an individual's physical health, psychological state, level of independence, social relationships, personal beliefs, and their relationships to salient features of the environment. NOTE: Quality of life is one way to measure the benefits or negative impacts of an \"improvement\" measured in terms of a physiological or psychological symptom. QoL research seeks to quantify what an intervention means to a patient's sense that their life has changed. NOTE: See also definition from FDA eCOA Glossary. [WHO Group, 1994]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "quantitative variable", "definition": "CDISC Definition: One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "query management", "definition": "CDISC Definition: Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "query resolution", "definition": "CDISC Definition: The closure of a query usually based on information contained in a data clarification.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "query", "definition": "CDISC Definition: A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor's representative to an investigator to resolve an error or inconsistency discovered during data review.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "questionnaire", "definition": "CDISC Definition: A set of questions or items shown to a respondent in order to get answers for research purposes. [PRO Draft Guidance] See also instrument, survey.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "race", "definition": "CDISC Definition: An arbitrary classification of a taxonomic group that is a division of a species. It usually arises as a consequence of geographical isolation within a species and is characterized by shared heredity, physical attributes and behavior, and in the case of humans, by common history, nationality, or geographic distribution. (NCI)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "radiopharmaceutical medicinal product", "definition": "CDISC Definition: Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose. [DIRECTIVE 2001/83/EC Article 1.(11)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "random allocation", "definition": "CDISC Definition: Assignment of subjects to treatment (or control) groups in an unpredictable way. NOTE: in a blinded study, assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "random number table", "definition": "CDISC Definition: Table of numbers with no apparent pattern used in the selection of random samples for clinical trials.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "random sample", "definition": "CDISC Definition: Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "randomization", "definition": "CDISC Definition: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Randomization can be executed according to imposed rules to achieve desired distribution. For example, unequal randomization is used to allocate subjects into groups at a differential rate, e.g., three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "randomized controlled trial (RCT)", "definition": "CDISC Definition: A well-controlled clinical trial in which subjects are assigned to treatment or control groups according to randomization principles. See randomization. [After FDA and Clinical Drug Trials : A Short History, S.White Junod, 2008; CONSORT statement] See also randomization, clinical trial, controlled study, adequate and well-controlled studies.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "raw data", "definition": "CDISC Definition: Data as originally collected. Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations. Researcher's records of subjects/patients, such as patient medical charts, hospital records, X-rays, and attending physician's notes. NOTE: These records may or may not accompany an application to a Regulatory authority, but must be kept in the researcher's file. See also eSource, source data, source documents.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RCRIM", "definition": "CDISC Definition: Regulated Clinical Research and information Management, which is a Technical Committee within HL7 (an acronym pronounced \"arcrim\").", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Real-World Data (RWD)", "definition": "CDISC Definition: Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. NOTE: Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for FDA's Real-World Evidence Program December 2018; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Evidence (RWE)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Real-World Evidence (RWE)", "definition": "CDISC Definition: The clinical evidence derived from analysis of Real-World Data (RWD) regarding the usage and potential benefits or risks of a medical product. [After FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017; IMI-GetReal Glossary Workgroup, 2016 GetReal - Project No. 115546, WP1: Deliverable D1.3; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Data (RWD).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "rechallenge", "definition": "CDISC Definition: To reintroduce a previously withdrawn or temporarily discontinued medical intervention to the same participant. NOTE: Rechallenge requirements may be described in the protocol. [After ICH M11]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "reconstruction (of a study)", "definition": "CDISC Definition: For eClinical trials FDA expects archival trial records to support review of the data as well as the processes used for obtaining and managing the data so that the trustworthiness of results obtained can be evaluated. NOTE: Reconstruction from records should support evaluation of the operation and validity of computerized systems and the conformance of the systems to applicable regulations during design and execution of the trial as well as during the period of record retention. [from CSUCT VI D, 21 CFR Parts 11, 312]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "record retention", "definition": "CDISC Definition: The act of maintaining or holding records for future use, often under the policies and procedures of a formally established regulatory records retention program, for some specified period of time. [After Rutgers University Institutional Planning and Operations, Records Management Definitions, https://ipo.rutgers.edu/business-services/records-management/definitions, accessed 2025-02-27; After ICH E6; After US FDA 21 CFR Part 11] See also personal data, processing (personal data).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "record", "definition": "CDISC Definition: In a regulated environment, documented information in any format that is subject to the requirements for data integrity, and should be controlled and maintained. NOTE: The requirements for data integrity are covered by the ALCOA plus principles. [After 21 CFR Part 11, Parts 210, 211, and 212; 21 CFR 312.61 and 312.62] See also data integrity, ALCOA plus, electronic record, control of electronic records, EHR (electronic health record), electronic personal health record (ePHR), EMR (electronic medical record), trustworthy (electronic records), source data, source document.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "recruitment (investigators)", "definition": "CDISC Definition: Process used by sponsors to identify, select, and arrange for investigators to serve in a clinical study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "recruitment (subjects)", "definition": "CDISC Definition: Process used by investigators to find and enroll appropriate subjects (those selected on the basis of the protocol's inclusion and exclusion criteria) into a clinical study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "recruitment period", "definition": "CDISC Definition: Time period during which subjects are or are planned to be enrolled in a clinical trial", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "recruitment target", "definition": "CDISC Definition: Number of subjects that must be recruited as candidates for enrollment into a study to meet the requirements of the protocol. in multicenter studies, each investigator has a recruitment target.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Reference information Model (RIM)", "definition": "CDISC Definition: An information model used as the ultimate defining reference for all HL7 standards. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "reference member state (RMS)", "definition": "CDISC Definition: A classification of a Member States in the Mutual Recognition Procedure (MRP) in the European authorization route resulting in a mutually recognized product. The first Member State that has authorized the product in the RMS. [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem .html] See also Mutual Recognition Procedure (MRP) and Concerned Member State (CMS).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "regenerative medicine advanced therapy (RMAT) designation", "definition": "CDISC Definition: An FDA designation for regenerative medicine therapies to treat, modify, reverse, or cure serious conditions that are eligible for FDA's expedited programs if they meet the criteria for such programs. [After http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm] See also regenerative medicine therapy (RMT), regenerative medicine.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "regenerative medicine therapy (RMT)", "definition": "CDISC Definition: A treatment to repair or replace damaged cells, tissues, or organs, including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. NOTE: RMT may include human gene therapies, genetically modified cells that lead to a sustained effect on cells or tissues, xenogeneic cell products, and any combination product where the biological product constituent part is a regenerative medicine therapy (biologic-device, biologic-drug, or biologic device-drug). [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine, regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "regenerative medicine", "definition": "CDISC Definition: A broad field of medicine that endeavors to create living functional human cells, tissues, and organs to repair or replace tissues or organ function lost due to age, disease, damage, or congenital defects. [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine therapy (RMT), regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "registry", "definition": "CDISC Definition: A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions. NOTE: The registry should contain basic information about each trial sufficient to inform interested subjects (and their healthcare practitioners) how to enroll in the trial. [FDAMA 113]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "regulatory application", "definition": "CDISC Definition: Application made to a health authority to investigate, market, or license a new product or indication.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "regulatory authorities", "definition": "CDISC Definition: Bodies having the power to regulate. NOTE: In the ICH GCP guideline the term includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "relative risk", "definition": "CDISC Definition: A measure of the risk of an event happening in one group or situation, compared to the risk of the same event happening in another group or situation. [After NCI Thesaurus; After FDA Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule Sept 2010; After EMA Glossary of Regulatory Terms]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "remote clinical trial", "definition": "CDISC Definition: A trial designed to reduce or eliminate travel by subjects to an investigative site for treatment and completion of study related procedures by implementing virtual visits (e.g., via electronic communication). [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also virtual, decentralized clinical trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "repeat rule", "definition": "CDISC Definition: Guide for repeating activities specified in protocol, including such features as the number of cycles and the criteria for stopping.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "replacement", "definition": "CDISC Definition: The act of enrolling a new study subject to compensate for a subject who is no longer participating.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "report", "definition": "CDISC Definition: A document that presents information in a structured format intended for a specific purpose and recipient. See also final report, interim clinical trial/study report, monitoring report, document (HL7), clinical study (trial) report.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "rescue medications", "definition": "CDISC Definition: Medicinal products identified in the protocol as those that may be administered to subjects when the efficacy of the investigational medicinal product (IMP) is not satisfactory, the effect of the IMP is too great and is likely to cause a hazard to the patient, or to manage an emergency situation. [After EU-CTR Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "research hypothesis", "definition": "CDISC Definition: A supposition or proposal based on observations or facts that requires further investigation or exploration to answer a research question. [After Shreffler J, Huecker MR. Hypothesis Testing, P Values, Confidence Intervals, and Significance. [Updated 2023 Mar 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557421/]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "residual risk", "definition": "CDISC Definition: In assessing the risk of re-identifying a trial participant, the risk that remains after controls are taken into account (the net risk or after controls). [Institute of Medicine report, Appendix B]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "response option", "definition": "CDISC Definition: One of several choices to be available for selection in response to a prompt, question or instruction (i.e., a stem) in a PRO item. See also common data element, stem.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "result synopsis", "definition": "CDISC Definition: The brief report prepared by biostatisticians summarizing primary (and secondary) efficacy results and key demographic information.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "results posting (results submission)", "definition": "CDISC Definition: The process of submitting and updating summary information about the results of a clinical study to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "results posting date (results submission date)", "definition": "CDISC Definition: The date and time the summary information about the results of the clinical study are submitted to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "retrospective data capture", "definition": "CDISC Definition: Capture of clinical trial data is retrospective when it is recalled from memory rather than captured contemporaneously in real-time. NOTE: Retrospective capture is important in PROs because of \"recall bias\" and other errors documented in psychological research comparing contemporaneous self-reported assessments and those that rely on recall from memory.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "retrospective study", "definition": "CDISC Definition: A study with planned observations collected predominantly before study start (i.e., backward-looking). NOTE: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [After ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "RHIO (Regional Health Information Organization)", "definition": "CDISC Definition: A group of organizations with a business stake in improving the quality, safety and efficiency of healthcare delivery. RHIOs are the building blocks of the proposed National Health Information Network (NHIN) initiative.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Risk Evaluation and Mitigation Strategy (REMS)", "definition": "CDISC Definition: A drug safety program of the U.S. Food and Drug Administration (FDA), which can be required for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. NOTE: REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. [US FDA, Risk Evaluation and Mitigation Strategies (REMS), https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems, Accessed 2025-05-22] See also risk-benefit assessment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "risk", "definition": "CDISC Definition: In clinical trials, the probability of harm or discomfort for subjects. NOTE: Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of troubling side effects. However, the possibility of unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "risk-based monitoring", "definition": "CDISC Definition: Study monitoring that focuses on preventing or mitigating important and likely risks to investigation quality, including risks to human subject protection and data integrity. [After FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, 2019] See also monitoring.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "risk-benefit assessment", "definition": "CDISC Definition: A qualitative and analytic evaluation of the potential harm effects and possible positive effects. NOTE: Assessments can be performed in the context of an intervention and/or the individual or population participating in a clinical trial. [After FDA Guidance on Benefit-Risk Assessment for New Drug and Biological Products, October 2023] See also Risk Evaluation and Mitigation Strategy (REMS).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "risk-benefit ratio", "definition": "CDISC Definition: A quantitative assessment of an activity's relative risks and benefits to the individual. NOTE: The term 'risk' refers to the possibility of experiencing a harm. [After NCI Thesaurus; After Coleman CH. Risk-Benefit Analysis. In: Laurie G, Dove E, Ganguli-Mitra A, et al., eds. The Cambridge Handbook of Health Research Regulation. Cambridge Law Handbooks. Cambridge University Press; 2021:130-138.; US FDA Benefit-Risk Assessment for New Drug and Biological Products, Guidance for Industry, October 2023] See also relative risk.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "role (CDISC classifier)", "definition": "CDISC Definition: Classifier for variables that describe \"observations\" in the SDTM. Role is a metadata attribute that determines the type of information conveyed by an observation-describing variable and standardizes rules for using the describing variable. [SDTM]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "route of administration (ROA)", "definition": "CDISC Definition: The way in which a pharmaceutical product is taken into, or makes contact with, the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SAFE", "definition": "CDISC Definition: BioPharma(TM) Digital Identity and Signature Standard.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "safety and tolerability", "definition": "CDISC Definition: The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs, and symptoms), and other special safety tests (e.g., ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "safety", "definition": "CDISC Definition: Relative freedom from harm. In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sample size adjustment", "definition": "CDISC Definition: An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. [After ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sample size calculation", "definition": "CDISC Definition: A statistical calculation to determine the number of subjects required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. [After ICH E9, 3.5]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sample size", "definition": "CDISC Definition: A subset of a larger population, selected for investigation to draw statistically valid conclusions or make estimates about the larger population. NOTE: This number is presented in the protocol and statistical analysis plan. [After ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "schedule of activities", "definition": "CDISC Definition: A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. See also schedule of assessments. Compare to study design schematic.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "schedule of assessments", "definition": "CDISC Definition: A tabular representation of planned protocol events and activities, in sequence. [after E3 Annexes IIIa and IIIb] Compare to study design schematic.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "screen failure", "definition": "CDISC Definition: At screening, when a potential subject does not meet study eligibility criteria. See also screening (of subjects). [After Segen's Medical Dictionary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "screen/screening (of substances)", "definition": "CDISC Definition: Screening is the process by which substances are evaluated in a battery of tests or assays (screens) designed to detect a specific biological property or activity. It can be conducted on a random basis in which substances are tested without any preselection criteria or on a targeted basis in which information on a substance with known activity and structure is used as a basis for selecting other similar substances on which to run the battery of tests. [SQA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "screening (of sites)", "definition": "CDISC Definition: Determining the suitability of an investigative site and personnel to participate in a clinical trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "screening (of subjects)", "definition": "CDISC Definition: A process of active evaluation for potential participation in a trial, including whether the protocol inclusion and exclusion criteria are met. [After FDA GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING] See also screen failure.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "screening (period)", "definition": "CDISC Definition: A period in a clinical study during which subjects are evaluated for participation in the study. See also screening (of subjects)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "screening trials", "definition": "CDISC Definition: A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "script", "definition": "CDISC Definition: A program or a sequence of instructions that are interpreted or carried out by another program or by a person.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "secondary objective", "definition": "CDISC Definition: The supportive or ancillary scientific question(s) the study is designed to answer. [After ICH E8] See also objective, primary objective, exploratory objective.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "secondary outcome variable", "definition": "CDISC Definition: Data on secondary outcomes are used to evaluate additional effects of the intervention. The primary outcome is the outcome of greatest importance. [after CONSORT statement] See also outcome, endpoint.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "secondary sponsor", "definition": "CDISC Definition: Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. [WHO, CTR item 6]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "self-evident change", "definition": "CDISC Definition: A data discrepancy that can be easily and obviously resolved on the basis of existing information on the CRF (e.g., obvious spelling errors or the patient is known to be a male and a date of last pregnancy is provided). See also discrepancy.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "semantic interoperability", "definition": "CDISC Definition: The ability of data shared by systems to be understood at the level of fully defined domain concepts. [ISO 18308]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "semantic", "definition": "CDISC Definition: In the context of a technical specification, semantic refers to the meaning of an element as distinct from its syntax. syntax can change without affecting semantics. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SEND (standard for the exchange of nonclinical data)", "definition": "CDISC Definition: The CDISC standard for the exchange of nonclinical data whose focus is on data collected from animal toxicology studies. [CDISC]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sensitive data", "definition": "CDISC Definition: Any piece of information that can be used to identify or cause harm to an individual person. NOTE: Examples include history of alcoholism, drug abuse, risky behavior, or venereal disease. Elements considered sensitive data between US and EU may differ. [After HIPAA; After EU Directive 95/46/EC; After Protection of Personal Data in Clinical Documents - A Model Approach, PHUSE] See also personal data, processing (personal data).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sensitivity (medical test)", "definition": "CDISC Definition: The proportion of positive tests out of all tests for subjects with a condition (true-positive rate). NOTE: Sensitivity represents the likelihood that a subject with the disease or other condition will have a positives test result. [After Diagnostic Testing Accuracy: Sensitivity, Specificity, Jacob Shreffler; Martin R. Huecker, Predictive Values and Likelihood Ratios, StatPearls Publishing, 2024 Jan; After Understanding Medical Tests and Test Results in Merck Manuals, Brian Mandell at Case Western University]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "serious adverse drug reaction", "definition": "CDISC Definition: Adverse drug reaction that at any dose of the drug: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, \"whether or not considered to be drug-related.\" CDISC recognizes that current usage incorporates the concept of causality. [1. WHO Technical Report 498(1972); 2. After ICH E2A, B] See ICH E6 definition and serious and severe definitions.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "serious adverse event (SAE)", "definition": "CDISC Definition: Adverse event that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, B] Compare to serious adverse drug reaction.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "serious adverse experience (SAE)", "definition": "CDISC Definition: Any experience that suggests a significant hazard, contra-indication, side effect or precaution. See also serious adverse event.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "serious breach", "definition": "CDISC Definition: A breach of Clinical Trial Regulation (EU) No 536/2014 or of the version of the protocol applicable at the time of the breach, which is likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial. [Article 52 of Regulation (EU) 536/2014 and Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol] See also privacy breach.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "serious risk", "definition": "CDISC Definition: Risk of a serious adverse drug experience. [505-1(b) of FD&C Act (21 USC. 355-1(b)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "server", "definition": "CDISC Definition: A computer that controls a central repository of data, files, and/ or applications that can be accessed and/or manipulated in some manner by client computers. NOTE: A file server hosts files for use by client machines. A web server supports browser-based use of central applications.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "severe", "definition": "CDISC Definition: A term for grading intensity on a relative scale describing a symptom, outcome, or event that is of a high level of intensity. Note: The term is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction or a Grade 3 adverse event in oncology). 'Severe' is different from 'serious,' which is based on patient/event outcome or action and serves as a guide for defining regulatory reporting obligations. The distinction is important to maintain when translating the concepts. [After ICH E2A, E2B; After CIOMS Cumulative glossary with a focus on pharmacovigilance. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2023.; After CTCAE] See also serious adverse event and serious adverse drug reaction.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sex", "definition": "CDISC Definition: Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other. Compare to gender. [The NCI Thesaurus contains biomedical terminologies that NCI does not own or control. This concept contains gender-related content that does not comply with Executive Order 14168.]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "side effect", "definition": "CDISC Definition: Any action or effect of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000. Page xxiv; Finding and Learning about Side Effects (adverse reactions), July 2018; What are side effects?, August 2018] See also adverse reaction, treatment effect, therapeutic effect.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sign", "definition": "CDISC Definition: An observation by a medical professional obtained from examination, test result, or questionnaire that indicates a patient may have a disease. NOTE: Some examples of signs are fever, swelling, skin rash, high blood pressure, and high blood glucose. [After NCI Glossary] See also diagnosis, symptom.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "signal of a serious risk", "definition": "CDISC Definition: Information related to a serious adverse drug experience associated with use of a drug and derived from-(a) a clinical trial; (b) adverse event reports; (c) a post-approval study; (d) peer-reviewed biomedical literature; (e) data derived from the post-market REMs. [505-1(b) of FD&C Act (21 USC. 355-1(b)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "single-blind study", "definition": "CDISC Definition: A study in which one party, either the investigator or the subject, does not know which medication or placebo is administered to the subject; also called single-masked study. See also blind study, double-blind study, triple-blind study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "single-entity product", "definition": "CDISC Definition: A product composed of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity. [After 21 CFR 3.2 (e) FAQ] See also combination product, co-packaged product, cross-labeled product.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "site investigator", "definition": "CDISC Definition: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [ICH E6 1.35. 2.] See also investigator, coordinating investigator, investigator/institution, principal investigator, sponsor-investigator, sub-investigator.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "SNOMED (Systematized Nomenclature of Medicine)", "definition": "CDISC Definition: A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. NOTE: Terms are applied to one of eleven independent systematized modules and presented in a multiaxial and hierarchical structure.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "social circumstances", "definition": "CDISC Definition: A set of concepts that results from or is influenced by criteria or activities associated with the social environment of a person. [NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "software as a medical device (SaMD)", "definition": "CDISC Definition: Software intended to be used for the performance of one or more medical purposes, without being part of a hardware medical device. [After \"Software as a Medical Device\": Possible Framework for Risk Categorization and Corresponding Considerations Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group Date: 18 September 2014]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "software validation", "definition": "CDISC Definition: Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. NOTE: Validating software thus should include evaluation of the suitability of the specifications to \"ensure user needs and intended uses can be fulfilled on a consistent basis\" (21 CFR 820.20). General Principles of software Validation; Final Guidance for industry and FDA staff, Jan 11, 2002. ISOIEC/IEEE 12207:1995 3.35; 21 CFR 820.20; 21 CFR 11.10(a); ISO 9000-3; Huber, l. (1999) See also validation, verification. Verification usually concerns confirmation that specified requirements have been met, but typically refers to the tracing of requirements and evidence of conformance in the individual phases or modules rather than suitability of the complete product. Validation is, \"the evaluation of software at the end of the software development process to ensure compliance with the user requirements\" (ANSI/ASQC A3-1978) and should not be thought of as an \"end-to-end\" verification. See also validation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "software verification", "definition": "CDISC Definition: The process that provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. NOTE: Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated [After 1. FDA General Principles of Software Validation; 2. ANSI/ASQC A3-1978; 3. ISO/IEC 17025:2017]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "software", "definition": "CDISC Definition: Computer programs, procedures, rules, and any associated documentation pertaining to the operation of a system.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "source data verification", "definition": "CDISC Definition: The process of ensuring that data that have been derived from source data accurately represent the source data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "source data", "definition": "CDISC Definition: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). [ICH E6; CSUCT]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "source document verification (SDV)", "definition": "CDISC Definition: The process by which the information reported by an investigator is compared with the source records or original records to ensure that it is complete, accurate, and valid. [Schuyl and Engel, 1999; Khosla et al., Indian J. Pharm 32:180-186, 2000] See also data validation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "source documents", "definition": "CDISC Definition: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medicotechnical departments involved in the clinical trial). See also eSource document, source, original data, certified copy. [ICH; CSUICI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "source", "definition": "CDISC Definition: The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. NOTE: The term identifies records planned (designated by the protocol) or referenced as the ones that provide the information underlying the analyses and findings of a clinical investigation. Accuracy, suitability, and trustworthiness are not defining attributes of \"source.\" The term is also sometimes used as shorthand for source documents and/or source data. [After ICH E6, CSUICI] See also source document, source data, original data, certified copy.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "special populations", "definition": "CDISC Definition: Subsets of study populations of particular interest included in clinical trials to ensure that their specific characteristics are considered in interpretation of data (e.g., geriatric). [FDA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "special purpose domain", "definition": "CDISC Definition: In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level non-observational domains, which are not classified under the SDTM general observation classes. Examples include trial design domains, relationship domains, etc. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, general observational class.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "specificity (medical test)", "definition": "CDISC Definition: The proportion of negative tests out of all tests for subjects who do not have a disease or condition (true-negative rate). NOTE: Specificity represents the likelihood that a subject without the disease or other condition will have a negative test result. [After Diagnostic Testing Accuracy: Sensitivity, Specificity, Jacob Shreffler; Martin R. Huecker, Predictive Values and Likelihood Ratios, StatPearls Publishing, 2024 Jan; After Understanding Medical Tests and Test Results in Merck Manuals, Brian Mandell at Case Western University]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "specified substance", "definition": "CDISC Definition: Substance defined by groups of elements that describes multi-substance materials or specifies further information on substances relevant to the description of Medicinal Products. NOTE: This could include grade, units of measure, physical form, constituents, manufacturer, critical manufacturing processes (e.g. extraction, synthetic or recombinant processes), specification and the analytical methods used to determine whether a substance is in compliance with a specification. [After ISO 11615:2017, 3.1.77]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sponsor", "definition": "CDISC Definition: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sponsor-investigator", "definition": "CDISC Definition: An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. NOTE: The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. [21 CFR 50.3f] [ICH E6] See also coordinating investigator, investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "standard deviation", "definition": "CDISC Definition: Indicator of the relative variability of a variable around its mean; the square root of the variance.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "standard of care", "definition": "CDISC Definition: A guideline for medical management and treatment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "standard operating procedures (SOPs)", "definition": "CDISC Definition: Detailed, written instructions to achieve uniformity of the performance of a specific function. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "standard treatment", "definition": "CDISC Definition: A treatment currently in wide use and approved by FDA or other health authority, considered to be effective in the treatment of a specific disease or condition.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "standard", "definition": "CDISC Definition: A repeatable written norm, pattern, or model that is generally accepted by agreement, established or approved by an authority, or widely accepted and used by custom. [After https://dictionary.cambridge.org/us/dictionary/english/standard, https://www.fda.gov/media/124694/download]. See also data standards, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Standards Development Organization (SDO)", "definition": "CDISC Definition: A domestic or international organization that plans, develops, establishes, or coordinates standards by using procedures that incorporate the attributes of openness, balance of interests, due process, an appeals process, and consensus. [After Office of Management and Budget (OMB) Circular A-119]. See also standard, data standards, CDISC standards, and Study Data Standardization Plan.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "statistical analysis plan", "definition": "CDISC Definition: A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "statistical distribution", "definition": "CDISC Definition: A group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. [AMA Manual of Style]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "statistical method", "definition": "CDISC Definition: The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [After FDA Guidance for Industry, E9 Statistical Principles for Clinical Trials, SEPTEMBER 1998]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "statistical power", "definition": "CDISC Definition: A measure of the likelihood that a significance test will detect an effect or difference in a sample if the effect or difference exists in the full population. NOTE: The power calculation is a function of factors such as sample size, effect size, and significance level. It is dependent upon the assumption that the differences between the compared treatments are unbiased estimates of the same quantity. [After McHugh ML. Power analysis in research. Biochem Med (Zagreb). 2008;18:263-274; After ICH E9] See also statistical significance, sample size, effect size.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "statistical significance", "definition": "CDISC Definition: The likelihood that an event occurs by chance (e.g., the null hypothesis is rejected). NOTE: For example, one may say \"significant at the 5% level\", which is usually represented as \"p <= 0.05\". This implies that there is a 95% probability that the effect did not occur by chance. [After AMA Manual of Style; After Principles of Epidemiology in Public Health Practice, Third Edition, An Introduction to Applied Epidemiology and Biostatistics, Oct 2006, Updated May 2012, US DHHS]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "stem", "definition": "CDISC Definition: The prompt, question, or instruction in a PRO item. See also response option, item.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "stochastic", "definition": "CDISC Definition: Involving a random variable; involving chance or probability.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "stopping rules", "definition": "CDISC Definition: A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "stratification", "definition": "CDISC Definition: Grouping defined by important prognostic factors measured at baseline. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "structured data", "definition": "CDISC Definition: Data that have been organized into discrete fields, and may be enumerated, numeric, or codified.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "structured health record information", "definition": "CDISC Definition: Structured health record information is organized into discrete fields, and may be enumerated, numeric, or codified. Examples of structured health information include: patient address (non-codified, but discrete field); diastolic blood pressure (numeric); coded result observation; coded diagnosis; patient risk assessment questionnaire with multiple-choice answers. Context may determine whether or not data are unstructured, e.g., a progress note might be standardized and structured in some eHR-s (e.g., subjective/objective/ assessment/Plan) but unstructured in others. [HL7 eHR-s FM Glossary of Terms, 2010].", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "structured product label (SPL)", "definition": "CDISC Definition: The structured product labeling (SPL) specification is an HL7 ANSI-approved document markup standard that specifies the structure and semantics for the exchange of product information. [HL7]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study arm", "definition": "CDISC Definition: A planned pathway through the study to which subjects are assigned, and that describes treatments, exposures, controls, and/or observations. [After BRIDG] See also control, control group.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study compensation", "definition": "CDISC Definition: Money or other forms of payment for participating in a study. NOTE: Compensation can either be offered in monetary forms, i.e., as payment, or non-monetary forms provided as goods or services. [https://health.ec.europa.eu/system/files/2023-06/payment_compensation_template_en.pdf; Payment and Reimbursement to Research Subjects, FDA, 2018] See also study reimbursement.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study completion date", "definition": "CDISC Definition: The date on which the final data for a clinical study were collected because the last study participant made the final visit to the study location (that is, last subject, last visit, or as otherwise defined in the study protocol). NOTE: See also study completion date data element on ClinicalTrials.gov.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study completion", "definition": "CDISC Definition: As defined in the protocol, the point at which all protocol-required activities have been executed. NOTE: According to EU CTR, this should be a clear and unambiguous definition of the end of the clinical trial in question and, if it is not the date of the last visit of the last subject, a specification of the estimated end date and a justification thereof should be included. [REGULATION (EU) No 536/2014 Article 2.26]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Study Data Standardization Plan (SDSP)", "definition": "CDISC Definition: A document that describes the data standardization strategy for clinical and nonclinical studies within a development program. NOTE: A Study Data Standardization Plan is intended to include historical, current, and planned information about the use of study data standards for studies to conform with the current technical formats, and terminologies described in the FDA Data Standards Catalog which applies to CDER, CBER, and CDRH. [After http://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf, https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources, https://www.fda.gov/media/102719/download] See also standards, data standards, CDISC standards, and Standards Development Organization.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study description", "definition": "CDISC Definition: Representation of key elements of study (e.g., control, blinding, dose, indication, configuration).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study design rationale", "definition": "CDISC Definition: Reason(s) for choosing the study design. NOTE: Reasons may include the choice of control, comparator or population, as well as the scientific or statistical rationale.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study design schematic", "definition": "CDISC Definition: A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. [CDISC Terminology; After ICH E3]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study design", "definition": "CDISC Definition: A strategy that specifies the structure of a study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. NOTE: Additional elements may include choice of control group(s), method of allocating treatments, blinding methods, and minimization of bias. [After Pocock, Clinical Trials: a Practical approach; After ICH E8; After ICH E9] See also Trial Design Model, arm, epoch, visit, parallel trial, crossover trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study feasibility", "definition": "CDISC Definition: The likelihood that a study will be completed as designed.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study life cycle", "definition": "CDISC Definition: The flow of events that characterize a research study from start to finish. [NCI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study monitoring", "definition": "CDISC Definition: The act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study participant", "definition": "CDISC Definition: A member of the clinical study population from whom data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, vulnerable subjects, data subject, clinical research subject, participant.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study population", "definition": "CDISC Definition: A group of individuals taken from the general population who share a set of common characteristics, such as age, sex, or health condition, precisely defined in the study protocol. This is a population to which the study results could be reasonably generalized. (CDISC Protocol Entities)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study publication date", "definition": "CDISC Definition: The date of the publication of scientific articles or abstracts about a clinical study. NOTE: Institute of Medicine (IOM) Report: The committee noted support for open and free access to scientific publications immediately upon publication, as well as the requirement of the U.S. Food and Drug Administration (FDA) to make a summary of clinical trial results available to the public. [ClinicalTrials.gov]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study reimbursement", "definition": "CDISC Definition: Money paid to the study subject/participant to offset personal expenses incurred during study participation, as agreed to by the sponsor and participant. See also study compensation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study report completion date", "definition": "CDISC Definition: The date at which the study report is considered final and will not be subject to any further change prior to submission. NOTE: For interventional studies of adults the study report completion date should be one year from the end of the LPLV, or end of study; for pediatric interventional studies this date should be six months. For non-interventional studies the study report completion date should be one year from the end of the LPLV, end of study, or end of data collection. [EU CTR]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study results", "definition": "CDISC Definition: The findings from a research study to include data, statistical analyses, and clinical interpretation. [After ICH E3] See also clinical study report, outcome, result synopsis, outcome of study.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study start date", "definition": "CDISC Definition: The date on which the protocol-defined study start criteria are met. NOTE: The US FDA defines the study start date for clinical studies as the earliest date of informed consent among any subject that enrolled in the study. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] See study start. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study start", "definition": "CDISC Definition: The criteria for study start, as defined in the protocol, are met.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "study variable", "definition": "CDISC Definition: A term used in trial design to denote a variable to be captured on the CRF. See also variable.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "sub-investigator", "definition": "CDISC Definition: Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [After ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "subject completion", "definition": "CDISC Definition: The case where a subject ceases active participation in a trial because the subject has, or is presumed to have followed all appropriate conditions of a protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "subject data event", "definition": "CDISC Definition: A subject visit or other encounter where subject data are collected, generated, or reviewed. [SDTM]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "subject identification code", "definition": "CDISC Definition: A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "subject monitoring", "definition": "CDISC Definition: Act of tracking, reporting, and review of a clinical trial subject's status and/ or performance of required activities per protocol. NOTE: Examples include monitoring compliance with treatment and scheduled tasks, tracking measures of symptoms, self reported feelings, and/or behaviors. Subject monitoring supports managing of patient safety and well being by site staff as defined in a protocol. Compare with medical device, medical monitoring.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "subject trial contact", "definition": "CDISC Definition: Any activity, anticipated in the study protocol, involving a subject and pertaining to collection of data. See visit.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "subject-reported outcome (SRO)", "definition": "CDISC Definition: An outcome reported directly by a subject in a clinical trial. [Patrick, D.l., 2003] See also patient-reported outcome (PRO).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "submission model", "definition": "CDISC Definition: A set of data standards (including SDTM, ADaM, and define.xml) for representing data that are submitted to regulatory authorities to support product marketing applications. NOTE: CDISC submission data consist of: tabulations that represent the essential data collected about patients; analysis data structured to support analysis and interpretation; and metadata descriptions.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "subprocessor", "definition": "CDISC Definition: An authorized third-party to carry out processing activities on a data processor's behalf. [Article 4 GDPR Definitions] See also personal data, processing (personal data), data processor.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "superiority trial", "definition": "CDISC Definition: A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "supplier (system)", "definition": "CDISC Definition: An organization that enters into a contract with the acquirer for the supply of a system (such as a software product, or software service) under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "surrogate endpoint", "definition": "CDISC Definition: An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource]. See also endpoint.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "surrogate marker", "definition": "CDISC Definition: A measurement of a drug's biological activity that substitutes for a clinically meaningful endpoint. [After Russell Katz, Biomarkers and Surrogate Markers: An FDA Perspective, NeuroRx. 2004 Apr;1(2):189-95.]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "surrogate variable", "definition": "CDISC Definition: A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "survey", "definition": "CDISC Definition: Any means (e.g., questionnaire, diary, interview script, group of items) that is used to collect PRO data. NOTE: survey refers to the content of the group of items and does not necessarily include the training and scoring documents generally not seen by respondents. [from ISOQOL comments on PRO Guidance] Compare to instrument.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "suspension (of a clinical trial)", "definition": "CDISC Definition: An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA \"clinical hold\". [After EU CTR] See also clinical hold (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "symptom", "definition": "CDISC Definition: A physical or mental experience or observation reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "synergistic effect", "definition": "CDISC Definition: An interaction between bioactive compounds or drugs that is deemed greater than the sum of each individual component. NOTE: The terms additivity, synergism, and antagonism should be used with care, unless the specific pharmacological pathways or mechanisms of action of the investigated drugs are known. [After Calzetta L, Koziol-White C. Pharmacological interactions: Synergism, or not synergism, that is the question. Curr Res Pharmacol Drug Discov. 2021 Aug 11;2:100046.] See also synergistic effect, antagonistic effect, drug interaction.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "synopsis", "definition": "CDISC Definition: Brief overview prepared at the conclusion of a study as a routine part of a regulatory submission, summarizing the study plan and results; includes numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc. [after ICH E3]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "syntactic", "definition": "CDISC Definition: The order, format, content of clinical trial data and/or documents as distinct from their meaning. NOTE: Syntactic interoperability is achieved when information is correctly exchanged between two systems according to structured rules whether or not sensible meaning is preserved. See also semantic, semantic interoperability.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "synthetic data", "definition": "CDISC Definition: Data that are artificially created rather than being generated by actual events. NOTE: Data are often created with the help of algorithms and used for a wide range of activities, including as test data for new products and tools, for model validation, and in AI optimization. [After The Ultimate Guide to Synthetic Data in 2020, August 29, 2020]. See also artificial intelligence.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "system", "definition": "CDISC Definition: People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives. [ANSI]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "t-test", "definition": "CDISC Definition: A statistical test used to compare the means of two groups of test data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "table of roles and responsibilities", "definition": "CDISC Definition: A cumulative record documenting operational access and authorizations of study personnel to electronic systems used in eClinical trials.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "tabulation dataset", "definition": "CDISC Definition: A dataset structured in a tabular format. NOTE: The CDISC Study Data Tabulation Model (SDTM) defines standards for tabulation datasets that fulfill FDA requirements for submitting clinical trial data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "target enrollment", "definition": "CDISC Definition: The planned number of subjects intended to be enrolled within a study to reach a pre-specified sample size (in any cohort or the entire study). NOTE: Target enrollments are set so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by agreement, algorithm, or other specified process. [After clinicaltrials.gov] See also accrual, target population.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "target population", "definition": "CDISC Definition: The group of people in the general population to which the study results can be generalized.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "technology provider", "definition": "CDISC Definition: A person, company, or other entity who develops, produces, and sells software applications and/or hardware for use in conducting clinical trials and/or in analyzing clinical trial data and or submitting clinical trial information for regulatory approval.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "temporary halt (of a clinical trial)", "definition": "CDISC Definition: An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [After EU CTR] See also termination (of a clinical trial), clinical hold (of a clinical trial), suspension (of a clinical trial).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "term", "definition": "CDISC Definition: One or more words designating something. NOTE: In a controlled vocabulary, terms are considered to refer to an underlying concept having a single meaning. Concepts may be linked to several synonymous terms.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "termination (of a clinical trial)", "definition": "CDISC Definition: Discontinuation of a trial prior to plan as defined in the protocol. NOTE: Additional information can be found in Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual: Premature Termination or Suspension of a Clinical Trial, 19 January 2021. See also discontinuation, suspension (of a clinical trial), clinical hold (of a clinical trial), temporary halt (of a clinical trial).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "terminology", "definition": "CDISC Definition: Set of concepts, designations, and relationships for a specialized subject area. NOTE: In the context of clinical research in human subjects, a standardized, finite set of terms (e.g., CDISC Terminology, MedDRA codes) that denote patient findings, circumstances, events, and interventions. See also glossary, vocabulary. Contrast with nomenclature.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "therapeutic area", "definition": "CDISC Definition: A category for a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention. (After NCI)", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "therapeutic effect", "definition": "CDISC Definition: The intended beneficial effect of an intervention on the body or disease. NOTE: Contrast with side effect, which is an unintended effect. [After Zhang P, Wang F, Hu J, Sorrentino R. Exploring the relationship between drug side-effects and therapeutic indications. AMIA Annu Symp Proc. 2013 Nov 16;2013:1568-77.] See also treatment effect, side effect.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "therapeutic index", "definition": "CDISC Definition: The ratio of the dose that produces toxicity (denominator) to the dose that produces a clinically desired or effective response (numerator). NOTE: The therapeutic index is a measure of a drug's safety, because a larger value indicates a wide margin between doses that are effective and doses that are toxic. [After Finkel, R, Clark, M. A., Champe, P. C. & Cubeddu, L. X. (eds) Lippincott's Illustrated Reviews: Pharmacology 4th edn (Lippincott Williams & Wilkins, 2008).]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "token", "definition": "CDISC Definition: Physical key that provides access to a secure electronic system or location.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "traceability (data)", "definition": "CDISC Definition: The ability to track data from source data collection through final use in reporting or analysis to ensure data interoperability, integrity, and interpretability. See also data integrity.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "transcription", "definition": "CDISC Definition: Process of transforming dictated or otherwise documented information from one storage medium to another. NOTE: often refers explicitly to data that is manually transcribed from source docs or measuring devices to CRFs or to eCRFs.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "transition rule", "definition": "CDISC Definition: A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan. See branch.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "translation", "definition": "CDISC Definition: Converting information from one natural language to another while preserving meaning. Compare to mapping.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "translational research", "definition": "CDISC Definition: The multidirectional integration of basic research, patient-oriented research, and population-based research, with the long-term aim of improving the health of the public. NOTE: These studies are designed to translate basic science findings into clinically useful tools and applications and to ensure that new treatments and research knowledge reach the patients or populations for whom they are intended and are implemented correctly. [After Rubio DM, Schoenbaum EE, Lee LS, Schteingart DE, Marantz PR, Anderson KE, Platt LD, Baez A, Esposito K. Defining translational research: implications for training. Acad Med. 2010 Mar;85(3):470-5. and NCI Thesaurus]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "transmit", "definition": "CDISC Definition: To transfer data, usually electronically. NOTE: In eClinical investigations data are commonly transmitted from subjects to clinical study sites, within or among clinical study sites, contract research organizations, data management centers, and sponsors, or to regulatory authorities. [modified from CSUICI].", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "treatment benefit", "definition": "CDISC Definition: The impact of treatment as measured by survival or a COA of how patients feel or function. Direct evidence of treatment benefit is derived from clinical trial effectiveness endpoints that measure survival or a meaningful aspect of how a patient feels or functions in daily life. NOTE: Treatment benefit can be demonstrated by an advantage in either effectiveness or safety, or both. [After FDA Clinical Outcome Assessment (COA) Glossary] See also benefit summary, clinical benefit.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "treatment contrast interaction", "definition": "CDISC Definition: The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (e.g., center). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction, the direction of the contrast differs for at least one level of the factor. [ICH E9 Glossary]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "treatment effect", "definition": "CDISC Definition: Any intended or unintended effect of the intervention on the body or disease. NOTE: In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments. [After ICH E9] See also therapeutic effect, side effect, treatment contrast interaction.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "treatment", "definition": "CDISC Definition: Medical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis, adjuvant therapy, neoadjuvant therapy, palliative therapy.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "treatment-emergent adverse event", "definition": "CDISC Definition: An event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "trial design element", "definition": "CDISC Definition: A basic building block for time within a clinical trial comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.[CDISC PRM Project] See also epoch.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Trial Design Model", "definition": "CDISC Definition: Defines a standard structure for representing the planned sequence of events and the treatment plan of a trial. NOTE: A component of the SDTM that builds upon elements, arms epochs, visits; suitable also for syntactic interpretation by machines. [CDISC] See study design.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "trial site", "definition": "CDISC Definition: A physical location (e.g., healthcare organization, institution, or facility) directly involved in conducting or facilitating a particular clinical trial. NOTE: There may not be a physical location, see decentralized cluster. [After ICH E6 (R2)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "trial statistician", "definition": "CDISC Definition: A statistician who has a combination of education/ training and experience sufficient to implement the principles in the ICH E9 guidance and who is responsible for the statistical aspects of the trial. [ICH E9]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "triple-blind study", "definition": "CDISC Definition: A study in which knowledge of the treatment assignment(s) is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "trustworthy (electronic records)", "definition": "CDISC Definition: An attribute of records (data and documents) and signatures submitted to regulatory agencies referring to their suitability for making scientific findings of safety and efficacy that underlie public policy decisions pertaining to market authorization. Two key dimensions that determine the trustworthiness of eClinical trial data are data quality and data integrity. [after 21CFR Part 11]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "type 1 (or type I) error", "definition": "CDISC Definition: Error made when a null hypothesis is rejected but is actually true.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "type 2 (or type II) error", "definition": "CDISC Definition: Error made when an alternative hypothesis is rejected when it is actually true.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "type 3 (or type III) error", "definition": "CDISC Definition: Some statisticians use this designation for an error made when calling the less effective treatment the more effective treatment.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "type of comparison", "definition": "CDISC Definition: How treatment arms will be compared (e.g., safety, efficacy, PK/PD). May also include comparison to data from other studies or sources (e.g., historical control). [ICH E9, EudraCT (p.18)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "umbrella trial design", "definition": "CDISC Definition: A type of trial design under a master protocol designed to evaluate multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022]. See also master protocol.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "umbrella trial", "definition": "CDISC Definition: A type of trial conducted under a master protocol and designed to test multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022]. See also master protocol, adaptive design, umbrella trial design.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "unblinding", "definition": "CDISC Definition: Identification of the treatment assignment to the subject, investigators, and/or other trial personnel. [After EUPATI Toolbox: Within-trial decisions: Unblinding and termination. 2023]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "unexpected adverse drug reaction", "definition": "CDISC Definition: An adverse drug reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information (e.g., IB for an unapproved investigational product or PI/summary of product characteristics for an approved product, and/or scientific literature). [After ICH E6 (R2)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "unexpected serious risk", "definition": "CDISC Definition: A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug experience identified in the labeling, but differs because of greater severity, specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "uniform resource locator (URL)", "definition": "CDISC Definition: Address of a web page, for example, appliedclinicaltrialsonline.com.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "use case", "definition": "CDISC Definition: An explicit scenario designed to help in determining whether a system/process is capable of performing the functions required for a particular use. a use case might describe, for example, how a study coordinator would use a tablet computer to capture medical history data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "use error (device)", "definition": "CDISC Definition: User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm. [FDA, Applying Human Factors and Usability Engineering to Medical Devices]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "user site testing (UST)", "definition": "CDISC Definition: Any testing that takes place outside of the developer's controlled environment. NOTE: Terms such as beta test, site validation, user acceptance test, installation verification, and installation testing have all been used to describe user site testing. User site testing encompasses all of these and any other testing that takes place outside of the developer's controlled environment. [from General Principles of software Validation; Final Guidance, section 5.2.6]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "vaccine effectiveness", "definition": "CDISC Definition: Vaccine protection measured in observational studies that include people with underlying medical conditions who have been administered vaccines by different health care providers under real-world conditions. [How Flu Vaccine Effectiveness and Efficacy are Measured, Questions & Answers, CDC January 29, 2016] See also vaccine efficacy, efficacy, effectiveness, randomized controlled trial (RCT).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "vaccine efficacy", "definition": "CDISC Definition: The proportional comparison of infection rate or other disease endpoints between vaccinated and unvaccinated groups measured in randomized controlled trials. NOTE: The method for calculating vaccine efficacy can be found here: https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section6.html. Efficacy is a measurement made during a clinical trial, effectiveness is how well the vaccine works out in the real world. [After Greenwood et al., Proc R Soc Med. 1915; 8 (Sect Epidemiol State Med): 113-194, The Statistics of Anti-typhoid and Anti-cholera Inoculations, and the Interpretation of such Statistics in general. After Piero Ollario, The Lancet Infectious Diseases, Feb 17th, 2021] See also vaccine effectiveness, effectiveness, efficacy, randomized controlled trial (RCT).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "vaccine", "definition": "CDISC Definition: A medicinal product inducing immunity against disease, most often to prevent occurrence of a disease, (e.g., a preventative vaccine against infectious disease), but also to treat a disease, (e.g., a therapeutic vaccine against cancer). NOTE: The vaccines against infectious disease may contain various ingredients of diverse origin (such as inactivated or attenuated organisms, particular antigens related to the infectious agent, live recombinant vector against antigens in vivo and adjuvants) [After NCI Dictionary of Cancer Terms. After European Pharmacopoeia section 5.1.] See also treatment, prevention, prophylaxis, biological product, virulence.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "valid", "definition": "CDISC Definition: Well grounded on principles of evidence. [After FDA Glossary of Computerized System and Software Development Terminology]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "validation", "definition": "CDISC Definition: Process of establishing suitability to purpose. NOTE: Validation is accomplished by planning how to measure and/or evaluate suitability to purpose; then executing the plan and documenting the results. [ICH E6] See also software validation, data validation, psychometric validation, criterion validation (COA), content validation (COA), construct validation (COA).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "variable", "definition": "CDISC Definition: Any attribute, phenomenon, characteristic, or event that can have different qualitative or quantitative values. [After Statistical Language - What are Variables?, Australian Bureau of Statistics, October 2013] See also dependent variable, derived variable, global assessment variable, primary outcome variable, qualitative variable, quantitative variable, secondary outcome variable, study variable, supporting variables, surrogate variable.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "variance", "definition": "CDISC Definition: A measure of the variability in a sample or population. It is calculated as the mean squared deviation (MSD) of the individual values from their common mean. In calculating the MSD, the divisor n is commonly used for a population variance and the divisor n-1 for a sample variance.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "verification of data", "definition": "CDISC Definition: The checking of data for correctness or compliance with applicable standards, rules, and conventions. [FDA Glossary of Computerized system and software Development Terminology] See also source document verification (SDV).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "verification", "definition": "CDISC Definition: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements. Compare to validation where suitability to purpose is also established.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "virtual", "definition": "CDISC Definition: Connected but not physically co-located. NOTE: Refers to visits or encounters between investigators and subjects where information exchange is mediated through telemedicine, video conference rather than by physical presence of individuals at a shared location. Trials with one or more virtual visits are virtual trials. Where all data capture and trial procedures are conducted virtually, a trial or other investigation may be called fully virtual. [After FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards March 2020 Updated on July 2, 2020] See also remote clinical trial, decentralized clinical trial.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "virulence", "definition": "CDISC Definition: The ability of an infectious agent to cause severe disease, measured as the proportion of persons with the disease who become severely ill or die. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014] See also morbidity, vaccine.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "visit", "definition": "CDISC Definition: A protocol-defined clinical encounter that encompasses planned and contingent study interventions, procedures, and assessments that may be performed on a subject. [SDTM]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "vocabulary", "definition": "CDISC Definition: The collection of terms, which refer to concepts, that are used by, understood by, or available for use by an individual or group within a language system. [After NCI Thesaurus]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "vulnerable subjects", "definition": "CDISC Definition: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [After ICH E6 R2 Glossary] See also human subject, patient, human subject, data subject, clinical research subject, participant, study participant.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "Warning Letter", "definition": "CDISC Definition: A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice. [FDA]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "washout period", "definition": "CDISC Definition: The interval of time that a participant enrolled in a study must not receive a specified treatment(s) before starting a study intervention(s). NOTE: A washout may be required before joining a study or before changing treatments within a study. [After https://metastatictrialtalk.org/inside-clinical-trials/washout-period/]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "web browser", "definition": "CDISC Definition: A computer program that interprets HTML and other Internet languages and protocols and displays web pages on a computer monitor.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "web page", "definition": "CDISC Definition: A single page on a website, such as a home page.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "web scraping", "definition": "CDISC Definition: The automated process of programmatically and systematically collecting information on the web and processing it into more easily analyzable formats that can be serialized. [After NNLM, \"Web Scraping\", 05/25/22, https://www.nnlm.gov/guides/data-glossary/web-scraping] See also AI prompt, Generative AI (GenAI).", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "web server", "definition": "CDISC Definition: A computer server that delivers HTML pages or files over the World Wide Web. See also server.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "website", "definition": "CDISC Definition: A collection of web pages and other files. A site can consist of a single web page, thousands of pages, or custom created pages that draw on a database associated with the site.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "weighting", "definition": "CDISC Definition: An adjustment in a value based on scientific observations within the data.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "well-being (of the trial subjects)", "definition": "CDISC Definition: The physical and mental integrity of the subjects participating in a clinical trial. [ICH]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "withdrawal", "definition": "CDISC Definition: The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions. [After Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, September 21, 2010] See also discontinuation.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "within-subject differences", "definition": "CDISC Definition: In a crossover trial, variability in each subject is used to assess treatment differences.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "World Wide Web", "definition": "CDISC Definition: All the resources and users on the Internet that are using HTTP protocols. Also called the web and www.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "XML (eXtensible Markup Language)", "definition": "CDISC Definition: A set of rules for encoding documents and data in a format that is both human readable and machine readable. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019; After W3C Extensible Markup Language (XML)] See also eXtensible markup language (XML) data element, Define-XML.", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "zoonosis", "definition": "CDISC Definition: An infectious disease that is transmissible from animals to humans. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014]", "sources": [ "CDISC Glossary.xlsx" ], "source": "CDISC Glossary.xlsx", "type": "excel", "file": "glossary.json" }, { "term": "The Multi", "definition": "Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard", "sources": [ "https://mrctcenter.org/glossaryterm/clinical-research/" ], "source": "https://mrctcenter.org/glossaryterm/clinical-research/", "type": "web", "file": "glossary.json" }, { "term": "Post-Trial Responsibilities", "definition": "Continued Access", "sources": [ "https://mrctcenter.org/glossaryterm/clinical-research/" ], "source": "https://mrctcenter.org/glossaryterm/clinical-research/", "type": "web", "file": "glossary.json" }, { "term": "Proactive Safety Surveillance", "definition": "A Global Approach", "sources": [ "https://mrctcenter.org/glossaryterm/clinical-research/" ], "source": "https://mrctcenter.org/glossaryterm/clinical-research/", "type": "web", "file": "glossary.json" }, { "term": "Project", "definition": "Specific Websites", "sources": [ "https://mrctcenter.org/glossaryterm/clinical-research/" ], "source": "https://mrctcenter.org/glossaryterm/clinical-research/", "type": "web", "file": "glossary.json" }, { "term": "Health and Human Services", "definition": "What is Medical Research?", "sources": [ "https://mrctcenter.org/glossaryterm/clinical-research/" ], "source": "https://mrctcenter.org/glossaryterm/clinical-research/", "type": "web", "file": "glossary.json" }, { "term": "FDA", "definition": "The Drug Development Process Step 3: Clinical Research", "sources": [ "https://mrctcenter.org/glossaryterm/clinical-research/" ], "source": "https://mrctcenter.org/glossaryterm/clinical-research/", "type": "web", "file": "glossary.json" }, { "term": "The Future is Connected", "definition": "Standards and AI Powering Digital Transformation", "sources": [ "https://www.cdisc.org/" ], "source": "https://www.cdisc.org/", "type": "web", "file": "glossary.json" }, { "term": "Access CDISC end-to", "definition": "end Foundational and Therapeutic Area standards", "sources": [ "https://www.cdisc.org/" ], "source": "https://www.cdisc.org/", "type": "web", "file": "glossary.json" }, { "term": "Therapeutic areas", "definition": "latest updates", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "Post", "definition": "authorisation", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "Podcast", "definition": "Inside EMA", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "HealthNotHype", "definition": "EMA's first social media campaign with creators", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "First-in", "definition": "class treatment to delay onset of type 1 diabetes", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "Wiskott", "definition": "Aldrich syndrome", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "Enpr", "definition": "EMA) November 2025", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "Start date", "definition": "20 November 2025, 13:00 (CET)", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "End date", "definition": "21 November 2025, 12:50 (CET)", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "EMA multi", "definition": "stakeholder workshop on artificial intelligence (AI)", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "European Medicines Agency", "definition": "Medtech Europe bilateral meeting", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "A Custom Webtools Rating widget", "definition": "Hidden by field_ema_hide_rating for this node.", "sources": [ "https://www.ema.europa.eu/" ], "source": "https://www.ema.europa.eu/", "type": "web", "file": "glossary.json" }, { "term": "South", "definition": "East Asia", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "COVID", "definition": "19 dashboard", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "Lifetime toll", "definition": "840 million women faced partner or sexual violence", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "Read WHO Director", "definition": "General's speeches", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "November 2025 12", "definition": "00 \u2013 13:00 CET", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "WHO EPI-WIN Webinar", "definition": "attributes of pathogen genomic data platforms supporting timely and equitable sharing", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "November 2025 13", "definition": "30 \u2013 15:00 CET", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "From Data to Impact", "definition": "Advancing Healthcare Associated Infection Surveillance for Safer Care and a Healthier Future", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "Beyond HLM4", "definition": "Implementing the 2025 Political Declaration on NCDs and Mental Health", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "November 2025 18", "definition": "30 \u2013 20:00 CET", "sources": [ "https://www.who.int/" ], "source": "https://www.who.int/", "type": "web", "file": "glossary.json" }, { "term": "Study record managers", "definition": "refer to the", "sources": [ "https://clinicaltrials.gov/" ], "source": "https://clinicaltrials.gov/", "type": "web", "file": "glossary.json" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "additive effect", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: additive effect\nGlossary Definition: The combined effect when two or more things are used together.\nUse in Context: The additive effect of a combination drug is the sum of the effects of each drug acting alone.\nMore Info: For example, two vaccines may be combined into one shot because they do not interfere with each other and will still each have the same effect as if they were given as two separate shots.\n\nSo an additive effect means that 1+1 = 2\nOther Info to Think About When Joining a Study: You may hear the words \u201cadditive effect\u201d being used if you are part of a study that is studying two or more treatments being taken together.\n\nYou may want to find out more about why the two treatments are being given together and what the hoped effect could be.\nRelated Terms: synergistic effect\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/additive-effect/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203914\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "adherence", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: adherence\nGlossary Definition: Following the study directions and requirements.\nUse in Context: Adherence to the study instructions is important so reliable information about the study treatment can be collected.\nMore Info: Adherence to the study protocol helps ensure the data from all study participants can be evaluated appropriately. \n\nReliable research results depend on both researchers and participants carefully following the protocol and study instructions.\n\nThe words 'adherence' and 'compliance' are often used in the same way.\nOther Info to Think About When Joining a Study: During study visits, someone from the study team may ask about your adherence to the study directions. That could mean following the exact directions for taking the investigational medicine or writing journal entries at specific time points.\n\nWhen you are reading through the consent form you may see that it says you could be removed from the study by the investigator if you are unable to follow the study procedures.\n\nYou may wish to ask what you should do if you were unable to follow the study directions on a particular day. For example, if you forgot to take the study treatment at the right time.\n\nIf you have a hard time following the study procedures, let the study team know so they can help you.\nRelated Terms: compliance, following\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/adherence/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25729\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "adverse event", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: adverse event\nGlossary Definition: Any health problem that happens during the study.\nUse in Context: The study team needs to know about all adverse events that happen during the study.\nMore Info: Researchers track adverse events for safety reasons. They also want to find out whether any issues could be related to the study treatment. \n\nParticipants should tell the study team about any health problem that happens while they are in a study. Any event such as a fever, headache, cold, a mood change, or falling, should be reported.\nOther Info to Think About When Joining a Study: You may see references to \u201cadverse event\u201d during the consent process when discussing procedures since many studies include specific time points to ask participants if they have experienced any health problems.\n\nYou may also see references to \u201cadverse event\u201d when discussing the risks of the study. Depending on the type of study you join, the risks you learn about are based on information participants in previous studies reported. It is important that you tell the study team about any health problem that happens during the study, even if you don\u2019t think it\u2019s related to the research.\nRelated Terms: adverse reaction, side effect\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/adverse-event/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C41331\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "adverse reaction", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: adverse reaction\nGlossary Definition: A health problem that happens during the study and is reported as possibly caused by the study treatment.\nUse in Context: Adverse reactions are important to track so that the effects of the study treatment are known.\nMore Info: Adverse reactions are health problems that are related to the study treatment. A rash that develops only after taking a drug is an adverse reaction.\nOther Info to Think About When Joining a Study: While participating in a study, the study team may discuss adverse reactions with you.\n\nAdverse reactions are health issues that have been found to be related to the study treatment. It is important for you to report any health problem or issue that happens while you are in a study, even if you don\u2019t think it\u2019s related.\nRelated Terms: adverse event, side effect\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/adverse-reaction/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C41332\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "analyze", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: analyze\nGlossary Definition: To examine study data to answer a question and help reach conclusions.\nUse in Context: Researchers analyze data to find out the results of a study.\nMore Info: In a research study, data are collected and then analyzed to answer the study questions. \n\nA study statistician helps analyze the data. When they analyze the data, they interpret the information and try to come to conclusions about what the study results mean.\nOther Info to Think About When Joining a Study: You may often hear the term \u201canalyze\u201d used by the study team in the context of data. Someone on the research team will need to analyze the data collected in the research study.\n\nYou may want to ask how the data will be analyzed and what the researchers want to learn from the study.\nRelated Terms: evaluate, investigate, interpret, data analysis\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/analyze/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25391\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "anonymize", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: anonymize\nGlossary Definition: Remove, change, or hide personal details to protect participant privacy.\nUse in Context: When researchers anonymize data they remove all personal identifiers, so that the participant cannot be linked back to that data by anyone.\nMore Info: When data are anonymized, details such as name, birthdate, and address are removed so that any personal information is no longer available to anyone.\nOther Info to Think About When Joining a Study: You may hear the term \u201canonymize\u201d when the study team talks about the data they collect from you during the study and how that data will be protected. There are different ways to protect data. When data are anonymized, they cannot be linked back to any individual.\n\nAs a participant, you can ask the study team for more information about what data they will collect and how they will protect your personal information. You may also want to clarify if the information they collect from you will be anonymized.\nRelated Terms: unlink, mask\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/anonymize/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142392\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "antibody", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: antibody\nGlossary Definition: A protein made by the body to fight an illness or infection. \nUse in Context: Antibodies develop after an infection to help clear the infection and to prevent the infection from coming back.\nMore Info: An antibody is a protein that is produced by the body's immune system and causes an immune response.\n\nAntibodies can be found in various areas of the body, including the blood, skin, lungs, tears, saliva, and even breast milk. \n\nAntibodies can be produced in response to viruses, bacteria, parasites and even medications. Antibodies can sometimes recognize someone\u2019s own body tissues and cause disease. \n\nIn some cases, antibodies can also be used as a treatment/therapy. For example, antibodies are sometimes used to fight cancer cells.\n\n\nOther Info to Think About When Joining a Study: A research study may test whether a study treatment causes a person to develop antibodies to a disease. It may also test an antibody to see if it can treat a disease. \n\nIf you have any questions about antibodies or immune reactions, you can ask the study team.\nRelated Terms: immune system, immunoglobulin, protein, antigen, immunotherapy\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/antibody/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C16295\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "antigen", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: antigen\nGlossary Definition: A substance that causes the body's immune system to react. \nUse in Context: An antigen is something that your body does not recognize and tries to fight.\nMore Info: The body reacts to an antigen like a virus, bacteria, parasite, or tumor.\n\nImmune reactions include getting a fever, a rash or hives, or feeling sick.\n\nOne of the ways that the immune system protects itself from antigens is to produce antibodies. \nOther Info to Think About When Joining a Study: You may see the term \u201cantigen\u201d in different research study situations. For example you may see it in the title of a research study, in the consent form, or in other study information. During the Covid pandemic, there was a lot of information about antigen tests.\n\nFeel free to ask a member of the study team for more information if you have questions about the term \u201cantigen\u201d being used in a research study.\nRelated Terms: antibody, immune response\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/antigen/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C268\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "arm", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: arm\nGlossary Definition: A group of participants in a research study who all receive the same study treatment.\nUse in Context: If a study has two arms, one group will receive one study treatment while a second group will receive a different study treatment such as a placebo or the standard of care.\nMore Info: Studies that compare two or more study treatments divide participants into separate arms to compare the effects of the different treatments.\nOther Info to Think About When Joining a Study: You may see the term \u201carm\u201d in the consent form or when the study team is explaining the research study to you. They may mention that there will be different arms in the study you are joining. You may be randomized to one arm or another\n\nYou can ask how many arms will be in a study. If there are arms, you can clarify how participants will be assigned to receive the different study treatments.\nRelated Terms: study arm, \ngroup, study assignment, randomization, cohort,\n treatment group\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/arm/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C15538\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "assent", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: assent\nGlossary Definition: Willingness to take part in a research study by someone who is not able to give legal consent.\nUse in Context: Some studies ask children, or people who have a guardian, to decide whether they agree to participate in research by giving their assent.\nMore Info: Assent can apply both to children and to adults who can't give legal informed consent. For example, an adult with severe dementia may no longer be able give consent but could be asked to assent\n\nConfirming the assent of children and adults who are unable to give legal consent treats them with respect, even if not legally necessary. \n\nFailing to object to being in a study is not considered assent. Assent can apply to children and adults who can't give legal informed consent. For example, in the case of an adult with dementia. \n\n To leave a study, a participant may take back their assent, or the legal guardian or authorized decision maker may take back their consent.\nOther Info to Think About When Joining a Study: The word \u201cassent\u201d may come up if minors are joining a study. When applicable, the parent or guardian may be signing to give consent, but the young person should be given the opportunity to assent to become a participant. The study team may also say that even if the guardian provides consent, the young person joining the study will need to give their assent before enrolling.\n\nA minor who is enrolling in a study should feel free to ask as many questions about the research as necessary to feel comfortable becoming a participant.\nRelated Terms: agreement, consent\nOther Resources: https://mrctcenter.org/resource/what-is-assent/\n\nhttps://mrctcenter.org/resource/assent-to-consent/\nTerm URL: https://mrctcenter.org/glossaryterm/assent/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203934\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "assent form", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: assent form\nGlossary Definition: A document used to explain the details of a research study to children or people who are unable to give legal consent. \nUse in Context: An assent form provides information about the research in a way that is easy to understand.\nMore Info: An assent form provides research study information in a way that children and others who may have impaired decision-making can understand. \n\n Giving children and people with impaired decision-making an assent form that is designed for them helps them to understand the research and decide how they feel about the study. \nOther Info to Think About When Joining a Study: If you are the parent or guardian of a child, you will be deciding about the study and signing the consent form. You can ask the study team if there is an assent form for the child to understand the study.\n\nA similar process can be followed if a study is enrolling adults who are not able to make decisions on their own about being in a research study.\n\nYou can use the assent form to guide a conversation to make sure the potential participant agrees with being in the research study.\nRelated Terms: assent, minor, guardian, consent, consent form\nOther Resources: https://mrctcenter.org/resource/what-is-assent/\n\nhttps://mrctcenter.org/resource/assent-to-consent/\nTerm URL: https://mrctcenter.org/glossaryterm/assent-form/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C161418\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "assessment", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: assessment\nGlossary Definition: Information that is collected and analyzed from a study participant.\nUse in Context: A study often includes assessments, like surveys or medical tests.\nMore Info: An assessment is used in research to collect data that helps the researchers answer the study questions.\nOther Info to Think About When Joining a Study: You may hear the word \"assessment\" when the study team tells you about the study procedures that will be done during the study. An assessment could be a questionnaire you do on your own or a procedure that is done by someone on the study team (like getting a blood pressure reading).\n\nAsk if you are not sure what the study assessment is for and what data are being collected. If the assessment involves any medical tests, you could ask if you need to do anything special to prepare.\nRelated Terms: test, questionnaire, survey, baseline assessment\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/assessment/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25217\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "baseline assessment", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: baseline assessment\nGlossary Definition: Information that is collected and analyzed from a study participant at the start of a study.\nUse in Context: A baseline assessment collects data about the participant\u2019s health status at the start of a study before any study treatment is given.\nMore Info: A baseline assessment is used to compare how the participant's health status changes during the study. \n \nFor example, if a study is measuring weight loss, the participant\u2019s weight must be taken at the start of the study to see if the participant loses weight while they are in the study.\n \n A baseline assessment could include questionnaires, lab tests, or other medical information for the study.\nOther Info to Think About When Joining a Study: You may hear thie term \"baseline assessment\" when the study team tells you about what you need to do for the research study. They may ask you to complete a \"baseline assessment\" to collect information at the start of the study. Some baseline assessments are done by the participant (like a survey) while others might be done with a person from the study team (like a blood draw).\n\nIf you do not understand the baseline assessment at the start of the study, please ask the study team to clarify.\nRelated Terms: assessment, questionnaire, survey\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/baseline-assessment/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142400\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "basket trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: basket trial\nGlossary Definition: A research study that tests one study treatment for different diseases and conditions.\nUse in Context: A basket trial is done to see whether a study treatment can work for multiple different conditions that have something in common.\nMore Info: A basket trial is a type of platform or master protocol study.\n\nA basket trial is done to find out whether one drug can treat multiple diseases.\n\nA basket trial enrolls patients with different diseases that have something in common.\nOther Info to Think About When Joining a Study: \n\nYou may hear about basket trials when you are learning about different types of study designs.\n\nIf you are thinking of joining a \"basket trial\" it means the study will be trying to find out if one treatment could help with a few different diseases or conditions. \n\n\nIf you are unclear what it means for a research study to be a basket trial, you should ask a member of the study team to clarify any of your questions.\n\nRelated Terms: \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/basket-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C209461\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "benefits of a research study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: benefits of a research study\nGlossary Definition: The ways a research study might help the participant and others.\nUse in Context: Learning about the possible benefits of a research study can help someone decide whether or not to enroll.\nMore Info: Research studies may have benefits for individuals and/or society. For example, a personal benefit of being in a research study might be regular health checks. A benefit to society may be helping future patients or the public, even if an individual participant does not directly benefit. Participants may not have any benefits from being in a research study.\nOther Info to Think About When Joining a Study: The consent form will include information about whether or not there will be direct benefits to you if you participate in a research study. \n\nYou should ask about more details of the benefits of the research, if there are any. You can also ask about the risks of participating in the study. \nRelated Terms: benefits of a clinical trial, benefits, advantages, pros\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/benefits-of-a-research-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203915\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "bias (research)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: bias (research)\nGlossary Definition: Flaws in the way a study is designed, done, or analyzed that lead to one conclusion being favored over another.\nUse in Context: Research bias can affect the results and outcomes of the research.\nMore Info: Bias in research can occur either on purpose or accidentally. Bias may cause false conclusions or misleading results. \n\nAll research study staff should be aware of, and reduce, potential sources of bias.\n\nResearch bias can occur when a study is being planned, conducted, or analyzed. Bias can happen based on data selection, study methods, individual experiences, or personal opinions. \n\nStatistical or personal factors and can cause results or findings to lean one way over another. For example, if a researcher only recruits participants who speak English, people who speak another language would not be represented.\nOther Info to Think About When Joining a Study: The concept of \"research bias\" may come up when reading results and trying to interpret the way the study was conducted. \n\nWhen you think about a study's results, you may have questions about whether there was any potential bias in the study, and how the researchers tried to avoid bias. \n\nBias is also something that you can discuss with the research team if you are considering being in a study or are currently a participant in a study.\nRelated Terms: prejudice, tendency, preference, predisposition, favoritism\nOther Resources: https://www.understandinghealthresearch.org/useful-information/common-sources-of-bias-2\nTerm URL: https://mrctcenter.org/glossaryterm/research-bias/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C28232\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "biomarker", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: biomarker\nGlossary Definition: Something in the body that is measured as an indicator of personal health or disease.\nUse in Context: Many different types of biomarkers can be measured in the body.\nMore Info: Biomarkers can be found in blood, body fluids, or tissues. They are sometimes related to a particular disease or condition.\n\nA biomarker can show how the body is working, and provide information about health. \n\nUnderstanding biomarkers is important for developing new drugs and medical devices. Biomarkers are one way to figure out whether the drug or device is working as intended.\n\nFor example, one biomarker is cholesterol. Cholesterol levels are a useful biomarker for heart disease. A research study might try to find out if a medication is helping lower cholesterol to prevent heart disease.\nOther Info to Think About When Joining a Study: A study that collects samples like blood or saliva from your body might be looking biomarkers. \n\nYou can ask the study team any questions you have about the kinds of biomarkers that might be studied and whether any of the results will be returned to you. \nRelated Terms: biological marker\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/biomarker/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16342\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "birth control", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: birth control\nGlossary Definition: A way to prevent pregnancy\nUse in Context: Using birth control may be required in some drug studies. \nMore Info: Birth control when any method, medicine, device, procedure, or behavior is used to prevent pregnancy.\n\nContraception is a form of birth control.\n\nSometimes birth control is needed in clinical trials if there is a possible risk to sperm or pregnancy development. \nOther Info to Think About When Joining a Study: A study you are thinking about joining may say that you need to use a birth control method. Some studies require a sexual partner to also use birth control. \n\nYou can ask the study team to explain why birth control is needed. You could ask what kind of birth control the study will want you to be on. You could also ask what will happen if you do get pregnant while on the research study. \nRelated Terms: contraception, pregnancy prevention, condoms, birth control pill, abstinence, hysterectomy, vasectomy, intrauterine device (IUD)\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/birth-control/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C37932\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "blood draw", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: blood draw\nGlossary Definition: Taking a sample of blood by using a needle.\nUse in Context: A blood draw from a vein is often needed for lab tests.\nMore Info: If a study includes a blood draw, it means one (or more) samples of the participant\u2019s blood will be taken for the research.\nOther Info to Think About When Joining a Study: Some research studies require one or more blood draws. The blood draw could happen at any study visit depending on the study you join. \n\nYou can clarify if and when you need a blood draw during the study. You may also want to ask if you need to do anything to prepare, like skip a meal if it is a fasting blood draw.\nRelated Terms: phlebotomy, blood sample\nOther Resources: https://catalyst.harvard.edu/publications-documents/blood-draw-for-research/?ref=true\nTerm URL: https://mrctcenter.org/glossaryterm/blood-draw/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C28221\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "clinical benefit", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: clinical benefit\nGlossary Definition: A health change that researchers measure to show that the study treatment helps the study participants.\nUse in Context: A study treatment may have clinical benefit if participants have some kind of improvement.\nMore Info: For example, the clinical benefit of a drug used in a diabetes study might be lowering and better controlling the blood sugar of participants.\nOther Info to Think About When Joining a Study: You may see the term \"clinical benefit\" when researchers describe what the study is trying to find out. In many cases what matters most to participants is understanding whether a study treatment will lead to having a clinical benefit like improved quality of life. You might want to ask if the study is measuring the clinical benefit of the study treatment.\nRelated Terms: benefits of a research study, benefits, advantages, pros\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/clinical-benefit/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142422\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "clinical research", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: clinical research\nGlossary Definition: A type of science that uses people's data to study health, illness, behaviors, or conditions in careful and defined ways.\nUse in Context: Clinical research is an organized way to find out about a condition or disease, how the condition progresses, how a treatment is given, or which treatments are safe and work best.\nMore Info: Clinical research includes many different types of studies, such as clinical trials, observational studies, and survey studies. Clinical research can be about individuals, populations, or public health.\nOther Info to Think About When Joining a Study: The term \"clinical research\" refers to any systematic way of studying health and illness. Clinical research is the way to learn more and find new medicines and treatments.\n\nYou may hear this term if a researcher asks you to take part in a clinical research study. For example, your doctor may ask if you want to be involved in research and consent to join a study.\nRelated Terms: health research, medical research, clinical trial, clinical study, research study, observational study, preclinical study\nOther Resources: \n\nhttps://www.youtube.com/watch?v=4pLsHhP7yTw&t=7s \n \n https://www.fda.gov/patients/drug-development-process/step-3-clinical-research\nTerm URL: https://mrctcenter.org/glossaryterm/clinical-research/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C51811\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Clinical Research Coordinator (CRC)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Clinical Research Coordinator (CRC)\nGlossary Definition: A research staff member who helps manage studies.\nUse in Context: A Clinical Research Coordinator works with the study doctor to help conduct the study.\nMore Info: One or more CRCs is assigned by the Principal Investigator who is leading the research to take care of specific study tasks. Tasks include preparing study documents, scheduling study visits, and collecting data. \nOther Info to Think About When Joining a Study: When enrolling in the study and going to study visits, you may meet with the clinical research coordinator. They may be the person explaining the study and consent process to you.\n\nIt may be useful to ask whether the clinical research coordinator is the person to contact if you have any questions about the study or any issues come up.\nRelated Terms: project manager, study coordinator, research coordinator, research nurse\nOther Resources: https://catalyst.harvard.edu/publications-documents/meet-the-research-team/?ref=true\nTerm URL: https://mrctcenter.org/glossaryterm/clinical-research-coordinator-crc/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142435\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "clinical trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: clinical trial\nGlossary Definition: A research study that tests drugs, devices and treatments to see if they are safe and work in people.\nUse in Context: Participants in a clinical trial help the study doctor learn more about a new treatment.\nMore Info: A clinical trial could study ways to diagnose, treat, or even prevent illness. Some clinical trials look at just one study treatment. Others might compare the study treatment to another treatment, a placebo, or even to a group that is taking nothing in order to measure how well the study treatment works.\nOther Info to Think About When Joining a Study: The term \"clinical trial\" is used for studies of people with various diseases and conditions. \n\nYou might be asked if you want to take part in a clinical trial. You may also read it on flyers asking for study volunteers. \n\nIt is important to understand the risks and benefits of the clinical trial before you enroll.\nRelated Terms: research study, trial, clinical study, study, interventional study, clinical research study, clinical research, control, placebo \nOther Resources: \n\nhttps://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials \n\n https://catalyst.harvard.edu/publications-documents/what-is-a-clinical-trial/?ref=true\nTerm URL: https://mrctcenter.org/glossaryterm/clinical-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C71104\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "clinician", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: clinician\nGlossary Definition: A health care provider.\nUse in Context: A clinician has special medical training to care for patients.\nMore Info: Clinicians include people who are doctors, medics, nurses, pharmacists, psychologists, physical therapists, occupational therapists, psychiatrists, and others.\nOther Info to Think About When Joining a Study: Any health care provider that you see regularly is a clinician. In health-related research studies, it may be a clinician who recruits and enrolls you. Additionally, a clinician may be in charge of a research study you join. \n\nYou can ask for the name and contact information of the clinician(s) running the research study. You may also want to discuss being in a research study with your own clinician before consenting to join a study.\nRelated Terms: allied health professional, healthcare provider\nOther Resources: \n\nTerm URL: https://mrctcenter.org/glossaryterm/clinician/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C85499\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "cohort", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: cohort\nGlossary Definition: A group of study participants that are similar in some way.\nUse in Context: Data were collected from a cohort of people over the age of 65 to see if the participants developed health problems.\nMore Info: A cohort is usually a group of people who are in an observational study to see how a disease or condition develops. A cohort is also the group of people in a clinical trial testing a study treatment for a specific disease or condition.\nOther Info to Think About When Joining a Study: You may hear the term \"cohort\" when the study team is describing the research study to you or when you are reading the study consent form. This term may come up when learning about the study groups and the different study treatments they may take or what different groups of participants may have to do differently.\n\nIt can be helpful to ask why a specific cohort was selected for the study you are joining and what the researchers would like to learn. \nRelated Terms: study cohort, study group, arm, observational study\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/cohort/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C61512\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Comparative Effectiveness Research (CER)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Comparative Effectiveness Research (CER)\nGlossary Definition: A study comparing two or more treatments.\nUse in Context: A comparative effectiveness research study compares at least two treatments to determine differences in outcomes.\nMore Info: Comparative effectiveness research compares treatments with drugs or devices, different ways to diagnose a condition, or how best to provide health care and services.\n\nAn example of a comparative effectiveness research study would be comparing Advil, Aleve, Tylenol, and Aspirin to see which is better for treating headaches. Generally, a placebo is not used in comparative effectiveness research.\nOther Info to Think About When Joining a Study: If you are thinking about joining a comparative effectiveness research study, you should understand what study treatments are being compared and why.\nRelated Terms: superiority trial, inferiority trial\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/comparative-effectiveness-research-cer/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203916\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "comparator", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: comparator\nGlossary Definition: Something that is compared to the study treatment.\nUse in Context: Studies with a comparator are usually trying to find out if there is a different outcome in the comparator group versus the group that gets the study treatment. \nMore Info: A comparator is also called a \"control.\" The group that gets the comparator is the \"control group.\"\n\nThe comparator can be an investigational or approved medicine, a placebo, or a different procedure or intervention.\n\nFor example, in a study of acupuncture for back pain, a comparator might be physical therapy or yoga.\nOther Info to Think About When Joining a Study: You may see the word \"comparator\" to describe another arm in the study. A comparator is often a treatment or intervention in common use and is used to see if the study treatment is worse, better, or somehow different. Feel free to ask any questions you might have about the comparator that is being used in a study.\nRelated Terms: Control, Reference, Benchmark, Comparison, Study treatment, Test article\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/comparator/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C142458\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "compensation (study)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: compensation (study)\nGlossary Definition: Money and other forms of payment that may be given to participants for completing study activities.\nUse in Context: Participants can ask the study team if compensation will be offered.\nMore Info: Some studies offer payment to participants. Study team members should explain any likely costs to participants for being in the research, and whether compensation or payment will be offered. This information may also be in the research consent form. \n\nCompensation in research is meant to help cover out-of-pocket costs to study participants, such as transportation, parking, meals, childcare, and to offset time out of work. If the study is unable to provide compensation, study team members should explain why.\n\n\n\nOther Info to Think About When Joining a Study: As a participant, you may hear or read about \"compensation\" when thinking about joining a study. This information about payments might be in the consent form, and a study team member may discuss this with you during the consent conversation. \n\nIf compensation is not mentioned, you should feel free to ask the study team if compensation or payment is provided. You may also ask how much compensation is provided, how the amount is determined, and what you need to do to ensure you can receive the compensation.\nRelated Terms: Reimbursement, Payment, Incentives\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/compensation-study/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C209471\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "compliance", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: compliance\nGlossary Definition: Following research requirements.\nUse in Context: Compliance with research rules and instructions improves the quality of a study.\nMore Info: Compliance in research refers to following regulations and guidelines about research. Researchers must be in compliance with research requirements and follow the approved protocol.\n\nCompliance also applies to participants who should follow study procedures.\n\nThe words 'adherence' and 'compliance' are often used in the same way.\nOther Info to Think About When Joining a Study: The consent form may say that the study team could remove you from the study if they notice your participation does not meet compliance requirements. Feel free to ask the study team for assistance is you are struggling with compliance due to issues such as lack of transportation, a reading disability, or just using new technology as part of the study. Keep the study team updated so they are aware of your situation. \n\nBoth the researchers and participants need to be compliant with guidelines and protocols when they are taking part in the research. The study team will tell you that there are certain things you must do to be part of the research study. Following these rules means you are compliant with the study procedure. \n\nIf you are unsure of what you should be doing during the study, ask the study team for more information.\nRelated Terms: adherence, following the rules or the law\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/compliance/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C39490\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Computerized Tomography (CT) scan", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Computerized Tomography (CT) scan\nGlossary Definition: A way to take pictures of the inside of a person's body using a type of radiation and a computer.\nUse in Context: A CT scan is able to show specific changes in a person's body (like changes in the brain, other tissues, organs or bones).\nMore Info: A CT scan is a type of imaging study.\nOther Info to Think About When Joining a Study: A CT scan may be needed in a research study. \n \nIf you know you have to get a CT scan for the research study, you can ask how the information will help the study. Also, you can ask if the CT scan results will be shared with you or your regular doctor, and how much radiation you will receive. This information could help you decide if you want to receive radiation from a CT scan done for research purposes.\nRelated Terms: imaging study, X-ray, MRI\nOther Resources: https://catalyst.harvard.edu/publications-documents/ct-scans-for-research/?ref=true\nTerm URL: https://mrctcenter.org/glossaryterm/computerized-tomography-ct-scan/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C17204\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "concomitant medications", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: concomitant medications\nGlossary Definition: Non-study medicines that are allowed to be taken at the same time as the study treatment.\nUse in Context: Researchers need to know about any concomitant medications a participant is taking while in a research study.\n\n\nMore Info: In research, concomitant medications are medicines that a participant takes at the same time as taking the study treatment. \n\nConcomitant medications are not the study treatment. \n\nThe study team needs to know about all the medicines that are being taken to make sure that they do not interfere with the research. \n\nFor example, if a participant takes a blood pressure medication, they should tell the study team and ask it is ok to keep taking it in the research study.\nOther Info to Think About When Joining a Study: Concomitant medications are reviewed by the study team to ensure that they are safe to take during the study \n\nIt is important to tell the study team about your other medications to ensure it is safe to take them while on the study. If you join a research study and need to start a new medication, contact the study team first. If any new health issues arise, be sure to discuss them with the study team.\nRelated Terms: usual medications, con-meds\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/concomitant-medications/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C70902\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "conduct", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: conduct\nGlossary Definition: To do a study or procedure.\nUse in Context: The study team helps conduct the research.\nMore Info: Depending on the study, the researcher may conduct a physical exam, survey, or interview to collect data for the research.\nOther Info to Think About When Joining a Study: The term \"conduct\" may come up in the consent form you are given when you're thinking about joining a study. It may mention that the study team is conducting this research or that your participation may help them conduct the research. \nRelated Terms: perform, run, execute, implement, carry out\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/conduct/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C153144\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "confidence interval", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: confidence interval\nGlossary Definition: The defined range of numbers used to describe where the results are expected to fall.\nUse in Context: A confidence interval is the range of values that a result is expected to fall in if the test is done again.\nMore Info: A confidence interval is a measure of variability. It is the likelihood that a measurement, when repeated, will fall within a given range. It can help researchers know how much to trust that a result can be repeated. \n\nThe smaller the confidence interval, the more certain the results are.\n \nThe term \"confidence interval\" is often abbreviated as \"CI.\"\nOther Info to Think About When Joining a Study: The term \"confidence interval\" will usually appear in publications about research studies when the article discusses the statistics and results.\n\nThe results section may provide more description about the confidence interval as well as define what it is for the specific study written about in the publication.\n\nThe confidence interval could also be included in the Plain Language Summary explaining the study results.\nRelated Terms: margin of error, probability, estimate\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/confidence-interval/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C53324\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "confidentiality", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: confidentiality\nGlossary Definition: Protecting personal information from people who should not have access.\nUse in Context: Confidentiality in research means researchers keep participant information private.\nMore Info: Researchers protect confidentiality by not sharing personal details about study participants with people who do not need to know as part of their work on the research.\nOther Info to Think About When Joining a Study: Confidentiality is very important in healthcare and clinical research. When talking or reading about the data that you will provide during the study, the study team may mention how they will protect your confidentiality. \n\nYou can always ask more about how the study team plans to protect your data and who will have access to it. Before you join a study, make sure you feel comfortable with how your data will be used and protected.\nRelated Terms: privacy, non-disclosure, data\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/confidentiality/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16466\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "confounding", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: confounding\nGlossary Definition: When the study outcome is influenced by outside conditions that were not expected by the study researchers.\nUse in Context: Researchers try to be aware of possible confounding factors that can affect their study results.\nMore Info: Confounding suggests there is a correlation between two or more things when really there is none. \n\nFor example, alcohol use is associated with lung cancer. Alcohol is not known to be related to lung cancer, but people who smoke often consume alcohol. Smoking is the confounder here, related to lung cancer and associated with alcohol use.\nOther Info to Think About When Joining a Study: Researchers design studies to try to avoid the amount of confounding that could impact the study results. If you are thinking about enrolling in a new study, you might ask the study team how the study was designed to try to prevent confounding.\n\nPregnancy is often considered a confounding factor for research. Some studies are designed to not allow pregnant people to participate because they aren't sure how the pregnancy would impact the results. If you are planning to become pregnant and are thinking about joining a study that does not allow pregnancy you should discuss this with the study team.\nRelated Terms: correlation; causation; cause and effect; dependent and independent variables\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/confounding/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C209462\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "consent form", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: consent form\nGlossary Definition: A document used to explain the planned research before a person decides whether or not to join a study.\nUse in Context: A person signs the consent form when they choose to take part in a study but only after they understand the information. \nMore Info: A consent form for a research study explains the research, potential risks and benefits, and all the details of a study. The consent form also includes information about other treatment options, the rights of participants, and the rules that the researchers need to follow. \n \n A consent form can be on paper or an electronic document.\nOther Info to Think About When Joining a Study: Most clinical research studies require a person to read and sign a consent form. A member of the study team should explain the study in detail and answer any questions you have. \n\nYou can ask for and keep a copy of the consent form from the study. Take the time to get your questions answered if anything is unclear so you understand what you will have to do during the study and how long the study is. Even after signing a consent form to join a study, remember you can withdraw from the study too. Just make sure to discuss with the study team so you can leave the study safely.\nRelated Terms: informed consent form, informed consent\nOther Resources: https://www.youtube.com/watch?v=Y7uI3sM9wtc\nTerm URL: https://mrctcenter.org/glossaryterm/consent-form/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16468\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Contract Research Organization (CRO)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Contract Research Organization (CRO)\nGlossary Definition: A group that is paid by the study sponsor to support research studies.\nUse in Context: A Contract Research Organization helps the sponsor run a study.\nMore Info: A Contract Research Organization (CRO) can be a commercial, academic, or other group that is contracted by the sponsor to perform one or more research functions. \n\nA CRO works with the study teams and often helps coordinate multiple sites. \nOther Info to Think About When Joining a Study: When reviewing the consent form, it may say that there is a Contract Research Organization (CRO) involved. \n\nYou could ask for more details about what the CRO is doing and what part they play in the study. \n\nYou can also ask whether any participant information is shared with the CRO.\nRelated Terms: sponsor, clinical research coordinator\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/contract-research-organization-cro/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C54148\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "contraindicated", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: contraindicated\nGlossary Definition: When things should not be used or done together because of possible harm.\nUse in Context: Researchers make sure that study procedures are not contraindicated before a participant enrolls in a study.\nMore Info: Researchers carefully check whether participants are receiving treatment or have a condition that would be contraindicated for the study intervention.\n\nFor example, a study of high-protein diets is contraindicated in people with kidney failure because high protein might harm the participant's kidneys.\n\nAn action or procedure could also be contraindicated in certain situations. For example, an MRI is contraindicated in someone who has anything metal in their body.\nOther Info to Think About When Joining a Study: The study team may tell you there are certain medications you cannot take or foods you cannot eat while you are participating in the study because they are contraindicated. For your safety you may not be allowed to join a study because you have a condition that may be contraindicated. \n\nBe sure to ask for clarification if you are unsure about what may be contraindicated. See if there is a list that you can keep that reminds you of what is contraindicated\nRelated Terms: harmful\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/contraindicated/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C37933\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "control group", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: control group\nGlossary Definition: The people in a study who do not receive the study treatment or do not have the condition being studied.\nUse in Context: A control group is used as a comparison to see the effect of the study treatment.\nMore Info: Participants in the control group receive something different during the research study compared to the intervention group. The control group might receive a different dose, standard of care, a placebo or no treatment at all.\nOther Info to Think About When Joining a Study: Whether a research study has a control group is important to understand. You could ask if the study you are thinking about joining will have a control group. If there is, you could ask what being in the control group will involve. For example, being in the control group could mean getting a placebo or the standard of care for the disease the study is looking at. You can also ask how participants will be assigned to the control group. This is often decided randomly, using randomization.\nRelated Terms: control arm, comparison group\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/control-group/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C28143\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "correlation", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: correlation\nGlossary Definition: When two or more measures are linked.\nUse in Context: There is a correlation between height and weight in that taller people tend to be heavier.\nMore Info: A correlation means that two things are associated. It does not mean that the one of the two things is caused by the other.\n\nA strong correlation means that two things are highly related\n\nA weak correlation means that two things are not very related.\n\nAn inverse correlation means that as one thing increases, the other decreases.\nOther Info to Think About When Joining a Study: The term \"correlation\" may be used to discuss how certain conditions or situations relate to each other. You may also hear about correlations in the context of how study results are presented and discussed. For example, a study may try to find out whether the study intervention is correlated with some specific outcomes.\nRelated Terms: relationship, association\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/correlation/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C48834\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "data", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: data\nGlossary Definition: Information collected from or about people taking part in a research study.\nUse in Context: Researchers use data to answer study questions.\nMore Info: There are many different types of data including:\n personal information like age and date of birth, questionnaires, blood test results, imaging scans and their interpretations, health insurance status and so on. \n \n The types of data collected depend on the study.\nOther Info to Think About When Joining a Study: Analyzing data is the way research questions are answered. You will usually hear the term \"data\" when researchers talk about the information they will be collecting about you during the study\n\nYou may want to clarify what data the study team will collect from you and how the data will be used for the research. You can also ask how the data will be protected and whether the data could be used for any other future uses.\nRelated Terms: information, questionnaire, assessment\nOther Resources: https://catalyst.harvard.edu/publications-documents/research-data-how-is-my-information-protected-and-used/?ref=true\nTerm URL: https://mrctcenter.org/glossaryterm/data/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142489\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB)\nGlossary Definition: An independent group of experts that reviews study data to make sure that patient safety is protected.\nUse in Context: A Data Monitoring Committee advises the study sponsor if any concerns about participant safety are found.\nMore Info: Data Monitoring Committees (DMCs) are also called Data and Safety Monitoring Committees (DSMC) or Data and Safety Monitoring Boards (DSMB). \n\nStudies that are randomized controlled trials, higher risk, or enrolling vulnerable populations (eg. children) usually include DMCs to review the data at specific timepoints, especially for adverse events that can affect participant safety.\n\nThe DMC reviews unblinded data on a regular schedule and as needed until the end of the study and advises on next steps in the event of adverse event(s).\n\nThe DMC also looks at whether a study should be stopped early (for example, for safety reasons or if there is no benefit to the study treatment) \nOther Info to Think About When Joining a Study: You may see or hear about a Data Monitoring Committee (DMC) if you are enrolled in a study that has one. The DMC looks at all study data and may request that the study team give you important new information that is learned. If there are any safety concerns, the DMC may advise that the study should be ended early.\nRelated Terms: DSMB, DSMC\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/data-monitoring-committee-data-and-safety-monitoring\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25474\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "database (research)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: database (research)\nGlossary Definition: Information that has been collected and organized to be used for research.\nUse in Context: A research database stores study information so that researchers can use it to answer study questions\nMore Info: Participants are usually given a code during the study so their identifiers are not saved in the same place as the other study data. A research database usually has coded information about the participants to protect their privacy. A database can be used in the present or in the future to answer new questions.\nOther Info to Think About When Joining a Study: You will hear the term \"database\" used in many different ways during the research process. \n \nIn research studies you may hear or read about the term \"database\" when the study team or consent form is describing how they will store data that is collected from the study. A database may also store personal information, like participant contact information. This information should be stored in a secure, protected way.\n \nYou may want to ask how your data will be stored if you join the study. You can also ask the study team who has access to the database and what information they will keep in the database. Additionally, you may want to ask how they will keep the database safe and secure.\nRelated Terms: data bank, registry, repository\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/database-research/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203935\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "discontinue (participant)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: discontinue (participant)\nGlossary Definition: To remove a study participant from a study.\nUse in Context: If a participant wants to stop being in a study, they should have a conversation with the study team about how to discontinue safely.\nMore Info: A participant can decide to discontinue being in a study. Sometimes a participant is discontinued by the researchers for safety or other reasons. Reasons for discontinuing and the transition from the study should be discussed with the participant before they leave the study.\nOther Info to Think About When Joining a Study: The term \"discontinue\" can be used in research to describe either leaving the study or stopping the study treatment. If you decide to discontinue any part of being in a study, please discuss with the study team how to do so safely first. This is to make sure that there are no likely health risks from ending study participation.\nRelated Terms: withdraw\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/discontinue-participant/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142444\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "discontinue (study treatment)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: discontinue (study treatment)\nGlossary Definition: To stop a study treatment in a participant.\nUse in Context: If a participant wants to stop the study treatment, they should first have a conversation with the study team about how to discontinue safely.\nMore Info: A participant can decide to discontinue a study treatment. Sometimes a study treatment can be discontinued by the researchers for safety or other reasons. Reasons for discontinuing should be discussed before the study treatment is stopped.\nOther Info to Think About When Joining a Study: The term \"discontinue\" can be used in research to describe leaving the study or stopping the study treatment. If you decide to stop taking the study treatment, please discuss this with the study team first. This is to make sure that there are no likely health risks from stopping the study treatment. Please also discuss how stopping the study treatment affects your participation in the study itself.\nRelated Terms: withdraw\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/discontinue-study-treatment/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C49502\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "disease progression", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: disease progression\nGlossary Definition: An illness getting worse over time.\nUse in Context: Disease progression refers to a disease or condition getting worse for a patient.\nMore Info: Disease progression can refer to a disease or symptoms getting worse. It can also refer to a person's functional abilities declining. \nOther Info to Think About When Joining a Study: Depending on the kind of study you are considering or reading about, you may see or hear references to \"disease progression\" during the informed consent process or other informational study materials. Disease progression may be used to explain the purpose of a study or explain the reason for particular procedures and tests. For example, a study could be collecting data on whether the disease progresses after taking a treatment. \n\nIf you have any questions about what it means for a study to look at disease progression, you should ask the study team.\nRelated Terms: \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/disease-progression/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C17747\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "disease-free survival", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: disease-free survival\nGlossary Definition: The length of time after treatment that a person lives without the illness coming back.\nUse in Context: Some studies look at disease-free survival to see whether the drug works to keep a disease from coming back.\nMore Info: Disease-free survival can be used to describe the length of time an individual or a group of participants within a study are free of their disease.\n\nNot every person in a study will necessarily have the same response to the study treatment. \nOther Info to Think About When Joining a Study: Depending on the kind of study you are considering or reading about, you may see or hear references to \"disease-free survival\" during the informed consent process or other informational study materials. \n\n\"Disease-free survival\" may be used to explain the purpose of a study or explain the reason for particular procedures and tests. For example, a study could be collecting data on disease-free survival after participants take a certain treatment. \n\nIf you have any questions about what it means for a study to look at disease-free survival, you should ask the study team.\nRelated Terms: relapse-free survival, remission\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/disease-free-survival/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C17751\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "dissent", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: dissent\nGlossary Definition: Refusing to be part of a research study.\nUse in Context: A child can dissent or refuse to participate even if their parent or guardian has consented for them to participate in a study.\nMore Info: Children and adults who are unable to give legal consent may dissent to participate at any point during the research. Researchers should honor dissent whether it is communicated in a verbal or non-verbal way. \n\nA participant can dissent and withdraw from most research at any time. Sometimes, when the research is likely to provide benefit to the individual receiving the intervention, dissent may not be honored, but every effort should be made to explain the reason to the participant. \nOther Info to Think About When Joining a Study: The term \"dissent\" may be discussed when a parent or guardian reviews the consent form. You should know that even if a guardian provides consent, they have to ask the person who will be in the study if they want to be in the study or not. The person will either want to be in the study and assent or they may not want to be and dissent. \n\nYou can ask if there is an assent process and what that process will be like. You may want to also ask what happens if the guardian gives consent but the potential participant dissents. \nRelated Terms: object, say no, refuse, decline, disagree\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/dissent/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203918\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "dose escalation study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: dose escalation study\nGlossary Definition: A kind of study where increasing amounts of a study treatment are given to different groups to find the best dose.\nUse in Context: In a dose-escalation study, the dose of a study treatment is increased one group at a time to find the best dose.\nMore Info: In a dose-escalation study, the first participant (or group of participants) gets the lowest dose of study medication. \n\nThe amount is increased with each participant or group to find the dose that gives the greatest benefit with the fewest side effects. \n\nThis process can help researchers choose the best dose for future studies. \nOther Info to Think About When Joining a Study: If you are considering participating in a dose escalation study, you may have questions about how the dose levels were determined and what safety information already exists. \nRelated Terms: Therapeutic Index\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/dose-escalation-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C90475\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "double-blind study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: double-blind study\nGlossary Definition: A study that is set up so that the study treatment that each participant receives is not known by the participants or the researchers\nUse in Context: In a double-blind study, the study participants and the study doctor don't know which treatment each participant is getting.\nMore Info: Double blind studies are done to minimize bias that can affect the study results.\n\nBias can occur when participants or researchers know which study treatment participants are getting\n \nParticipants can ask to find out which study treatment they received after the study ends.\nOther Info to Think About When Joining a Study: \n\nIf you are considering joining a double-blind study you can ask questions about how your safety will be monitored. If there is an emergency, it is possible to find out what study treatment you are taking so you can receive the medical care you need.\nRelated Terms: masked study, blinded study, masking, blinding, bias, single-blind study, randomization\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/double-blind-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C15228\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "drug holiday", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: drug holiday\nGlossary Definition: A time period decided between the participant and study team when a medication is stopped and then re-started. \nUse in Context: A person should always check with the study team and their doctor before stopping any medicine or taking a drug holiday.\nMore Info: A drug holiday is a planned break from taking a medicine or study treatment. \n\nPeople may take a drug holiday for study reasons, a health issue, or personal reasons. For example, having surgery may mean that all current medications, including any study treatments, need to be paused.\n\nA person should not stop taking any prescription or study medications without first discussing with their doctor and the study team first.\nOther Info to Think About When Joining a Study: If you are in a research study and would like to take a planned \"drug holiday\" to stop taking the study treatment you should first discuss it with the study team.\n\nAny time you plan to pause any of your prescribed medications you should ensure this is safe with your regular doctor and discuss how to stop taking your medications safely.\n\nFeel free to ask any questions you have about taking a drug holiday.\nRelated Terms: Medication vacation\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/drug-holiday/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203919\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "drug therapy", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: drug therapy\nGlossary Definition: The use of medicine to treat a disease, condition, or symptom.\nUse in Context: Clinical trials are done to learn more about the risks and benefits of a drug therapy.\nMore Info: There are many different types of drug therapy that can have multiples different purposes. \n\nA drug therapy could be used to:\n- make symptoms better, \n- treat a condition or disease, \n- lower the risk of getting a disease in the future, \n- or destroy harmful cells, like cancer cells.\nOther Info to Think About When Joining a Study: If a research study is testing a drug therapy it is important to understand the possible risks and benefits.\n\nYou can ask questions during the consent process, but also anytime during the study if any new questions come up. The study team is there to make sure you stay safe while you are taking a drug therapy.\nRelated Terms: Pharmacotherapy, Pharmaceutical therapy, Biologic, drug\n\n\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/drug-therapy/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C15986\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "e-consent (form)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: e-consent (form)\nGlossary Definition: An electronic version of an informed consent form.\nUse in Context: An e-consent form can be useful in studies that are being conducted remotely.\nMore Info: \n\nE-consent is a method of obtaining informed consent through the use of an electronic system instead of a paper consent form.\n\nParticipants may sign the form electronically and then they may be able to get a copy emailed to them or download it themselves.\nOther Info to Think About When Joining a Study: A study may have an e-consent form to join a study. \n\nYou could ask if you get a copy of the e-consent form and how you will get that copy. You could also ask if there is a paper version of the consent form for you if you want one. \nRelated Terms: electronic informed consent, digital consent, consent form, decentralized clinical trials\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/e-consent-form/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203920\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "effectiveness", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: effectiveness\nGlossary Definition: How well a treatment works.\nUse in Context: Effectiveness refers to how well a treatment, medicine or vaccine works in people who use it after it has been approved. \nMore Info: Effectiveness refers to how well a treatment works in the real world, not in a planned clinical trial. Usually effectiveness is assessed after approval by health or government authorities. \nOther Info to Think About When Joining a Study: The word effectiveness commonly comes up in the context of already approved medications. In contrast, efficacy, refers to how well a study treatment works in a study. The words \"effectiveness\" and \"efficacy\" are sometimes used to mean the same thing even though they have slightly different meanings.\nRelated Terms: Efficacy\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/effectiveness/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142522\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "efficacy", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: efficacy\nGlossary Definition: How well a study treatment works in the study.\nUse in Context: A study tests efficacy to see how well a new treatment works.\nMore Info: \n\nEfficacy is different from \"effectiveness\" which refers to how well the treatment works in the real world outside a study.\nOther Info to Think About When Joining a Study: The word \"efficacy\" can be used to describe how well the investigational intervention works in the controlled setting of a study. This term may be used when researchers describe an objective in the study. For example, a study could be testing the efficacy of a new vaccine.\nRelated Terms: effectiveness\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/efficacy/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C88183\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "eligibility criteria", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: eligibility criteria\nGlossary Definition: The reasons a person can be included in, or excluded from, a study.\nUse in Context: A study has eligibility criteria to make sure only people who fit the study requirements join as participants.\nMore Info: The eligibility criteria for a study are made up of inclusion criteria and exclusion criteria. For example, a study may be looking to include only people of a certain age or with a certain health condition.\nOther Info to Think About When Joining a Study: If you are interested in joining a clinical trial, the study team will ask you some questions and possibly do some medical tests to make sure you meet the eligibility criteria. This is for your safety and for scientific reasons so participants all meet specific criteria.\n\nIf you do not meet the eligibility criteria for one study, you can ask the study team if there are other studies that you could be a good fit for.\nRelated Terms: inclusion criteria, exclusion criteria\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/eligibility-criteria/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16112\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Emergency Use Authorization (EUA)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Emergency Use Authorization (EUA)\nGlossary Definition: A process to make a treatment or vaccine available during a public health emergency, before all research is complete, and before full approval is granted.\nUse in Context: Regulators decide whether to allow an Emergency Use Authorization.\nMore Info: An Emergency Use Authorization (EUA) makes medical treatments and vaccines available when the public's health is at risk, such as during a pandemic.\n\nUnder an EUA, medicines and vaccines are still being tested but the approval process is fast-tracked in order to make interventions available more quickly.\n\nAn EUA applies to the USA only. Other countries have different rules and regulations. \nOther Info to Think About When Joining a Study: The term \"Emergency Use Authorization\" may be something you heard during the Covid pandemic. If a treatment or vaccine is made available under an EUA, you may hear that there are still research studies to collect more data about the product. \nRelated Terms: \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/emergency-use-authorization-eua/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C96966\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "endpoint", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: endpoint\nGlossary Definition: A measure of the expected effect of the study treatment.\nUse in Context: An endpoint is one of the main questions the study is trying to answer.\nMore Info: A study could have more than one endpoint. Some examples of endpoints that are used in studies include finding out more about about a disease or condition, participant quality of life, or symptoms.\nOther Info to Think About When Joining a Study: The term \"endpoint\" is used to describe what the study will be looking at to see if the study treatment had an effect. You could see this term in consent documents or other descriptions of the study, including study results reports. \n\nIn general, the endpoint is reported as an average of all the data collected in the study. You may not have the same results as the overall study found. For example, a study treatment may have lowered blood pressure overall for study participants, but your blood pressure may not have changed while taking the study treatment.\n\nIf you have any questions about the study endpoint, you can ask the study team.\nRelated Terms: clinical endpoint, outcome, primary endpoint, secondary endpoint, surrogate\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/endpoint/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25212\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "enroll", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: enroll\nGlossary Definition: The action of a participant joining the study after providing informed consent.\nUse in Context: If you enroll in a study, it means you decided to volunteer to be a participant.\nMore Info: In order to enroll in a study, a person must meet the eligibility criteria. \n \nStudy participation is your choice. It is voluntary. \n \nIf the study includes randomization, this would be occur after the participant enrolls.\nOther Info to Think About When Joining a Study: You may hear the term \"enroll\" when the study team is asking if you want to join the research study. You may need to provide your informed consent by signing a consent form before you can enroll in the study.\n\nDo your best to understand everything you will be asked to do if you enroll in a study. Feel free to ask the study team any questions you have about the study. In many cases, you will be able to take the time to go home and think about it before deciding to enroll in a study.\nRelated Terms: join, informed consent, consent form, eligibility criteria, inclusion criteria, exclusion criteria, randomization\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/enroll/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C37948\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "epidemiologist", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: epidemiologist\nGlossary Definition: A person who studies where, why, how often, and to what populations health concerns and diseases happen.\nUse in Context: An epidemiologist analyzes data to look for patterns and causes of diseases or other health conditions in large groups of people.\nMore Info: Some studies include epidemiologists because they help search for the cause of a disease and identify who might be at risk. \n\nEpidemiologists also help figure out how to control or stop the spread of a disease.\nOther Info to Think About When Joining a Study: An epidemiologist tends to look at population health rather than individual health. If you learn that an epidpemiologist is a member of the study team, this means there is someone looking at how the disease or condition being studied affects large groups of people.\nRelated Terms: Disease detective\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/epidemiologist/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C17843\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "equivalence", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: equivalence\nGlossary Definition: When two or more things in a study are about the same.\nUse in Context: In clinical research, equivalence often refers to whether two study treatments are almost the same.\nMore Info: Treatments, therapies, vaccines, evaluation methods and study groups do not have to be exactly equal in order to have equivalence. \n\nInstead, equivalence means that the treatments are about the same in terms of how they work for patients. \nOther Info to Think About When Joining a Study: You may see the word \"equivalence\" when a study is trying to see if two or more study treatments have the same effect, or if a study has shown there is equivalence between study treatments.\n\nYou may want to ask about whether there are any known possible differences between study treatments that would be important for you to understand given your own personal health concerns and issues.\nRelated Terms: similarity, resemblance, equivalence study, non-inferiority study, equal\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/equivalence/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142539\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "equivalent (effect)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: equivalent (effect)\nGlossary Definition: The same or almost the same result.\nUse in Context: In research, an equivalent effect means that different study treatments or medication doses have about the same effect on patients.\nMore Info: An equivalent effect doesn't mean two treatments are exactly equal. Two treatments are equivalent if they have about the same risks and benefits.\nOther Info to Think About When Joining a Study: The word \"equivalent effect\" could be used to explain that one study treatment has a similar effect as another one.\n\nYou may want to ask about whether there are any known possible differences between study treatments that would be important for you to understand given your own personal health concerns and issues.\nRelated Terms: same, similar, equal outcome\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/equivalent-effect/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203921\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "evaluate", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: evaluate\nGlossary Definition: To examine, review, and understand.\nUse in Context: A study team member will evaluate the effect of the study treatment at participant study visits.\nMore Info: The study doctor evaluates the participant's response and safety in order to decide whether to continue the participation in a research study. The researchers also evaluate the quality of the data from a study to analyze the outcome. \nOther Info to Think About When Joining a Study: \n\nYou may see the term \"evaluate\" if you look up your study on clinicaltrials.gov or in the consent form. You may hear about participants being evaluated during the study based on certain measurements. This term may also come up when talking about evaluating the safety or efficacy of a new therapy or device \n\nIf the consent form talks about evaluating the participant, you may want to ask how they will evaluate you. Additionally, if the researchers are evaluating the efficacy or safety of a study treatment or device, you may want to know more about how they are going to do this and how the data will answer the study questions. \nRelated Terms: assess, check, check out, learn, judge, appraise\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/evaluate/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25214\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "exclusion criteria", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: exclusion criteria\nGlossary Definition: A list of reasons a person cannot be included in a study.\nUse in Context: If someone wants to join a study, they can not have any of the exclusion criteria.\nMore Info: Exclusion criteria are reasons that researchers cannot include a person in a research study. For example, if a study is only enrolling adults with diabetes, a person who does not have the condition could not take part.\nOther Info to Think About When Joining a Study: You may see the term \"exclusion criteria\" when learning about reasons why you might not be able to be included in a research study. \n\nThe study team will ask you some questions and possibly do some medical tests to confirm you can be included. This is for your safety and for scientific reasons to make sure you do not meet the exclusion criteria.\n\nIf you are unable to join one study, you can ask the study team if there are other studies that could be a better fit for you.\nRelated Terms: eligibility criteria, inclusion criteria\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/exclusion-criteria/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25370\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "expanded access", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: expanded access\nGlossary Definition: A process for a doctor to request an unapproved treatment for a seriously ill patient.\nUse in Context: Doctors can seek approval to use a study treatment outside of research via an Expanded Access application.\nMore Info: Expanded Access is a path for a patient with an immediately life-threatening or serious disease or condition to access an investigational medical product (like a drug, biologic, or medical device). Expanded Access can make treatment outside of clinical trials possible when no other treatments are available and there is no clinical trial for the patient to join.\n\nExpanded Access is also called \"compassionate use.\" Expanded Access is a program for doctors to request treatments that are not yet approved for seriously ill patients. This request is made by a patient's doctors using the Expanded Access application. The company that makes the experimental drug also has to approve the request. \nOther Info to Think About When Joining a Study: The concept of \"Expanded Access\" may be discussed if you are seriously ill or have a life-threatening condition, and the available treatments do not work for you. \n\n\"Expanded Access\" may also be discussed with you if there is no clinical trial for you to enroll in. \n\nYou can always discuss with your doctor if there is a new unapproved treatment that could be requested via expanded access. It is important to note that Expanded Access is for treatment; it is not considered research.\nRelated Terms: compassionate use, emergency use, pre-approval access\nOther Resources: \n\nhttps://www.fda.gov/news-events/public-health-focus/expanded-access\nTerm URL: https://mrctcenter.org/glossaryterm/expanded-access/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C98722\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "experimental", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: experimental\nGlossary Definition: Something that is being tested in research but not yet proven.\nUse in Context: An experimental medicine is studied before it is approved.\nMore Info: Experimental treatments go through research studies to make sure the risks and benefits to participants are better understood.\n\nBefore a drug, vaccine, or device is approved by regulators for a particular use, disease, or group of patients it is considered to be experimental.\nOther Info to Think About When Joining a Study: Clinical research is designed to find out more about health, disease, prevention and treatment. \n\nThe word \"experimental\" may be used to describe what a research study is testing, for example an experimental treatment. This means that the treatment has not yet been proven or approved but there is reason to believe that it might work well. \n\nThrough research, experimental treatments can become approved treatments. If you have any questions about anything experimental in a research study, you should ask the study team.\nRelated Terms: investigational\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/experimental/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C28041\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "exploratory research", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: exploratory research\nGlossary Definition: A process to find facts that can guide the design of future studies.\nUse in Context: Exploratory research is helpful to find out how to approach future research questions.\nMore Info: Exploratory research clarifies the question to be solved. It does not result in final conclusions or solutions.\n\nExploratory research can test whether a method or study design can be used, or whether an outcome can be measured in a reliable way.\n\nSometimes exploratory research is done using samples stored in biobanks.\nOther Info to Think About When Joining a Study: You may see the term \"exploratory research\" to describe early research that was done to figure out processes and inform the next study. \n\nIf you are thinking about joining a research study, you can always ask what exploratory research informed the design of the study, or what exploratory research might be conducted with the data that is collected during the .\nRelated Terms: pilot, preliminary studies\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/exploratory-research/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C147146\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "focus group", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: focus group\nGlossary Definition: A group interview to learn what people think about a topic.\nUse in Context: A focus group offers participants a chance to discuss their experiences with each other and the researcher.\nMore Info: A focus group is a way to get many different people together to hear about what they think about a certain topic. A focus group is usually led by a member of the study team. Since focus groups collect information from a few people at the same time it is important to respect everyone's privacy when participating and not share details about the other people outside the study.\nOther Info to Think About When Joining a Study: You may be asked to participate in a \"focus group\" as part of a study. You may ask any questions about the focus group such as what information will be collected, how data will be collected, whether the focus group will be recorded, whether there will be a note taker, and how many people will be in the room.\n\nYou can also ask how the data will be used and/or shared, and how your privacy will be protected. Feel free to ask any questions you have about being in a focus group.\nRelated Terms: group interview\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/focus-group/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C154589\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "frequency", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: frequency\nGlossary Definition: How often something happens over a period of time.\nUse in Context: The frequency of study visits should be clear to anyone joining a research study.\nMore Info: Frequency refers to how many times something will happen. It also describes the number of times something occurs in a specific period of time.\nOther Info to Think About When Joining a Study: The word \"frequency\" can be used in many different situations. For example, this term could be used to talk about the \"frequency of study visits\" you may have to make if you participate in the study. This term could also be used to talk about how often you have to take the study treatment or how often you need to fill out a questionnaire. If you experience some type of symptom while taking the investigational product, the study team may ask about the frequency of these symptoms.\n\nIf you have any questions about how often you have to do something in order to participate in the study, please ask with the study team. \nRelated Terms: number, prevalence, recurrence, repeat, incidence\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/frequency/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25515\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "generalizability", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: generalizability\nGlossary Definition: How research results can apply to people who were not part of the study.\nUse in Context: A study has generalizability if the results are useful and can apply beyond the original study participants.\nMore Info: Ideally, research findings should have generalizability to people outside of the study.\n\nGood generalizability means research results can be broadly applied to a large number of people who are similar in some way . \n\nPoor generalizability means that the results can only be applied to the study population or very specific situation.\nOther Info to Think About When Joining a Study: You may hear the term \"generalizability\" when the study team is describing what they hope the outcome of the research study will be. \n\nYou could ask the study team at the beginning of the study if they expect the research results to have generazability to larger groups. You can also ask how generalizable the results are likely to be. \n\nThe word may also be used in publications about research, especially in the \"Discussion\" section. \nRelated Terms: usefulness, meaning\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/generalizability/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142429\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "genetic testing", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: genetic testing\nGlossary Definition: A medical test that could identify a health risk to a person or their biological family members by looking at their genes (DNA).\nUse in Context: Genetic testing is done on cells from blood, tissues, and other fluids from the body.\nMore Info: In clinical research, genetic testing looks for changes in DNA that are different from what is most common.\n\nGenetic testing is done on DNA, which is the genetic material found in cells. DNA provides instructions for how the body grows and develops. Changes or differences in DNA are called variants. Some variants may be linked to increased risk for a disease and affect personal health. However, not every variant is understood or has a known health effect, and more could be learned about its effect in the future.\nOther Info to Think About When Joining a Study: You may hear the term \"genetic testing\" from both your regular doctors and researchers involved in studies. You may even hear about genetic testing kits that you can buy yourself. \n\nSome research studies may have genetic testing as part of the study or offer it to participants if they are interested. If genetic testing is part of a research study, you may want to ask more questions, including what information could be learned during testing, what different results could mean for you or your biological family members, and if there are any risks associated with the testing. Sometimes differences are found but whehter those differences are important is unclear. Discussing these possibilities with the study team could be helpful.\n\nYou may want to ask if you will receive the results from genetic testing and if these results will be shared with anyone else besides the study team. You may also want to ask if there will be a genetic counselor to explain the results to you if the study team shares this information with you.\nRelated Terms: variant, SNP, mutation\nOther Resources: https://www.genome.gov/genetics-glossary \n\nTerm URL: https://mrctcenter.org/glossaryterm/genetic-testing/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C15709\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "hazard ratio", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: hazard ratio\nGlossary Definition: A measure of risk that compares two treatments in the same study.\nUse in Context: Studies with more than one group use hazard ratios to compare whether one group has more adverse events than the other.\nMore Info: The hazard ratio is the relative risk of an event happening in one group compared to another. \n\nFor example, in a drug study, the group getting the study treatment may have headaches two times more than the control population. The hazard ratio would be 2, meaning that the study treatment group has twice the chance of getting headaches compared to the comparison group.\nOther Info to Think About When Joining a Study: You might see the word \"hazard ratio\" in research reports and articles that describe the results of research studies. This is a technical math term and will not usually be used in materials designed especially for patients and participants. \n\nIf you see this word in a study document for a study you are considering, enrolled in, or completed, you can ask the researcher or study team any questions you might have.\nRelated Terms: progression-free survival, relative risk\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/hazard-ratio/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C93150\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "healthy volunteer", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: healthy volunteer\nGlossary Definition: A study participant who does not have a disease or condition, including the one being studied.\nUse in Context: A healthy volunteer should not have any known diseases or conditions. \nMore Info: A healthy volunteer may test the study treatment's safety \n or be the comparison (control) during the study.\nOther Info to Think About When Joining a Study: Some studies recruit healthy volunteers. You may see the term \"healthy volunteer\" in the consent form or other information about the study.\n\n If you are healthy and wish to volunteer for a study, you will be screened to make sure you meet the study criteria. Feel free to ask the researchers any questions you might have about what the study is about and what you will be asked to do if you join. \nRelated Terms: participant, subject, study participant, research participant, research subject, study subject, healthy control\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/healthy-volunteer/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C49651\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "hereditary", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: hereditary\nGlossary Definition: A parent's features and traits being passed to their biological children before birth.\nUse in Context: Traits that are hereditary include eye color and sometimes an increased risk of a certain disease.\nMore Info: Some physical or behavioral traits are hereditary. This means the traits are transferred from the parents to their biological children through genes and before the children are born. \nOther Info to Think About When Joining a Study: \n\nYou may see the term \"hereditary\" used in a variety of different situations. It could be used when explaining why a disease might develop or a study to look at hereditary condition. \n\nFor example, hereditary may be used in a consent form to describe a type of disease that is being studied.\n\nIf you are confused or have questions, you should feel free to ask your study team for more information.\nRelated Terms: genotypic phenotypic, mental health, physical info, traits (the manifestation of genetic information)\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/hereditary/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C27998\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "hypothesis", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: hypothesis\nGlossary Definition: An idea that is tested in a research study.\nUse in Context: The hypothesis in a research study is tested to see if it is true or not. \nMore Info: A hypothesis is sometimes described as an educated guess, idea, or question that is a starting point for research. The hypothesis is usually presented as a statement, that is tested during the research.\n\nFor example, a research study may have the hypothesis that one treatment causes fewer side effects than another. The study would be designed to test whether that is true.\nOther Info to Think About When Joining a Study: The word \"hypothesis\" may be used in discussions about what researchers are trying to learn through the study. You may see this word in the title of the study you are thinking of participating in or in the background information\n\nYou may also hear the study team talking about testing their hypothesis through the research. The word \"hypothesis\" can also appear in publications about the statistics and data collected from the study. \n\nYou can always ask the study team about the hypothesis that is being tested through the research.\nRelated Terms: premise, supposition, thesis, theory\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/hypothesis/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142668\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "immune response", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: immune response\nGlossary Definition: The body\u2019s reaction to a substance, illness, or infection.\nUse in Context: An immune response is the body's way to fight something it thinks might be harmful.\nMore Info: The immune response is how the body identifies and defends itself against germs like bacteria, viruses, and substances that seem to be harmful. An immune response helps the body stay safe. \n\nFor example, a vaccine works by causing an immune response so that the body can fight off the germ, and remember to attack it if the germ ever comes back.\nOther Info to Think About When Joining a Study: You may see the term \"immune response\" used in a variety of ways in the research study context. For example, a study may be researching participants' immune responses to certain things or how different investigational products may affect a person's immune response.\n\nIf you have questions about a study that is looking at immune response, be sure to ask your study team for more information.\nRelated Terms: Immune system, antigen, antibody\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/immune-response/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C17930\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "incentive", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: incentive\nGlossary Definition: Something that supports or encourages research participation.\nUse in Context: An incentive to join research might be to help researchers learn more about a condition or find a new treatment. \nMore Info: Incentives for research participation can be feeling good personally, receiving a gift card or payment, or getting entered into a raffle. \n\nIncentives can also include payment beyond the costs of participating or access to free medication. Incentives often help enrollment. \n\nA participant should never feel that an incentive pressures them to join the study or remain in the study.\n\n\nOther Info to Think About When Joining a Study: You may hear the term \"incentive\" before you enroll in a study. The study team may provide incentives for you showing up to study visits or when you complete the study. \n\nYou may want to ask if study incentives could impact your eligibility for any social benefits if you are using things like SNAP or are on disability. Incentives can be in the form of money and may need to be reported on your taxes.\n\nYou should feel free to discuss with the study team whether any kind of incentive will be offered and in what form.\nRelated Terms: offer, motivation\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/incentive/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C53277\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "incidence", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: incidence\nGlossary Definition: Number of new cases or events during a period of time.\nUse in Context: The incidence rate tells us how many new cases of a specific disease or condition develop during a certain period of time.\nMore Info: Measuring the incidence is a way to keep track of how many new cases or events happen in a population at risk during a given time period.\n\nThe incidence is generally reported as a rate. \n\nFor example, in a study with 10 participants, if 3 people report headaches after taking the study medication and 7 do not, the incidence of headaches is 30% (3/10 = .3 or 30%)\nOther Info to Think About When Joining a Study: You might see the word \"incidence\" used to describe the frequency of a disease or condition. \n\nThe word can also be used to describe the expected or actual number of adverse events in a study.\nRelated Terms: frequency, rate, prevalence\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/incidence/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16726\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "inclusion criteria", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: inclusion criteria\nGlossary Definition: A list of requirements a person must meet to take part in a study.\nUse in Context: If someone wants to join a study, they must meet all the inclusion criteria.\nMore Info: For example, if a study is for adults only, a person can only consider joining if they are 18 years of age or older.\nOther Info to Think About When Joining a Study: You may hear the term \"inclusion criteria\" when researchers talk about who can join a study. \n\nThere may be reasons why a person cannot be included in a research study. \n\nBefore you join a study, the study team will ask you some questions and possibly do some medical tests. This is for your safety and for scientific reasons to confirm that you meet the requirements of the study.\nRelated Terms: eligibility criteria, exclusion criteria\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/inclusion-criteria/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25532\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "informed consent", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: informed consent\nGlossary Definition: The process of learning and discussing the details of a research study before deciding whether to take part.\nUse in Context: Informed consent is required for most research studies before a person can join as a participant.\nMore Info: Informed consent is an ongoing conversation that occurs before someone can participate in a study and whenever information about the study changes.\n \nA consent form is used as part of the informed consent process.\nOther Info to Think About When Joining a Study: You may hear about \"informed consent\" often before you join a research study, and throughout your participation. A member of the study team will explain the research and answer any questions you have.\n\nBefore you agree to join a study, you should understand what the research is about and what you will need to do if you enroll. \n\nDo not be afraid to ask as many questions as you need to. Someone from the study team should answer and clarify anything that is confusing. You can also take time to think about whether you want to join a study or not.\nRelated Terms: consent, consent form\nOther Resources: \n\nhttps://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials\nTerm URL: https://mrctcenter.org/glossaryterm/informed-consent/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16735\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "infusion", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: infusion\nGlossary Definition: A way to give a fluid to the study participant, usually through a vein.\nUse in Context: A study treatment given to a participant through their vein is an infusion.\nMore Info: In an infusion, the fluid could be a study treatment or other liquids, like ones that are given for hydration.\nOther Info to Think About When Joining a Study: The term \"infusion\" will be used if there is a study treatment that is given through an infusion. If you are thinking about joining a study that has one or more infusions, you can ask what the infusion is for and what it contains. \n\nYou can always ask the study team to clarify any study procedures. \nRelated Terms: intravenous infusion, intervention, intravenous injection \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/infusion/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C15388\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Institutional Review Board (IRB)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Institutional Review Board (IRB)\nGlossary Definition: A team of people who review studies to protect the rights and welfare of study participants.\nUse in Context: Participants can only enroll in a study after an IRB reviews and approves the study protocol.\nMore Info: A research study must be approved by an IRB before it starts.\n \n The IRB members are not part of the study team. IRB members come from many different backgrounds and can be medical, scientific or non-scientific experts.\nOther Info to Think About When Joining a Study: You may see the term \"institutional review board\" in the consent form in a section about which group approved the study.\n\nYou may also hear members of the study team talk about the IRB and getting the IRB's approval before any study activities can take place.\n\nThe contact information of the IRB that is overseeing a study should be included in the consent form. You can reach out to the study's IRB if you have any concerns or complaints about your experience being in a research study.\nRelated Terms: committee for the protection of human subjects, independent ethics committee, independent review board, research ethics committee, ethics committee\nOther Resources: https://www.youtube.com/watch?v=U8fme1boEbE\nTerm URL: https://mrctcenter.org/glossaryterm/institutional-review-board-irb/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16741\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "intermittent", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: intermittent\nGlossary Definition: Not regular or predictable.\nUse in Context: The participant reported intermittent dizzy spells since the last study visit.\nMore Info: When something is intermittent, it means that it happens more than once, but does not happen on a schedule, is not planned, and is not predictable.\nOther Info to Think About When Joining a Study: The term \"intermittent\" may come up when discussing adverse events that could happen during a research study. You can always discuss with the study team any questions you have about the possible adverse events in a study. \nRelated Terms: time to time, randomly, occasionally, on and off, every so often, Infrequently\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/intermittent/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C71325\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "investigational medicine", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: investigational medicine\nGlossary Definition: A treatment or drug that is not yet approved for the condition being studied.\nUse in Context: Being in a research study is one way a patient might have access to an investigational medicine.\nMore Info: Every country has health authorities or government agencies that review and approve studies of investigational medicines. They then use the study data on risks and benefits to decide whether the investigational medicine is safe and effective and whether it can be approved for the condition or purpose.\nOther Info to Think About When Joining a Study: You may learn about an \"investigational medicine\" if you are thinking about joining a study that is looking at a treatment that is not yet approved. Your doctor or the study team may mention the investigational medicine in discussions or in the consent form. \n\nYou could ask the study team to explain more about why the investigational medicine is being studied. You may also want to ask about how the investigational medicine has been studied before and what the study objectves are.\nRelated Terms: investigational use, experimental drug/medicine, study treatment, intervention, investigational product, investigational drug, study medication, study medicine, drug candidate\nOther Resources: \n\nhttps://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-investigational-drugs\n\nhttps://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=34&ContentID=22702-1\nTerm URL: https://mrctcenter.org/glossaryterm/investigational-medicine/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C202579\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Investigational New Drug (IND) application", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Investigational New Drug (IND) application\nGlossary Definition: An application to the United States Food & Drug Administration (FDA) to get permission to use a drug in a research study that enrolls people.\nUse in Context: Researchers submit an Investigational New Drug application to the FDA to get permission to study a new use for a drug.\nMore Info: The Investigational New Drug (IND) application is specific to the United States (US). Researchers testing a new drug, or an approved drug for a new use, must get approval of an IND from the US Food and Drug Administration (FDA). The FDA is a government agency that regulates drugs and devices that are used in patients. Once approval is obtained, the research is often said to be conducted \"under an IND.\"\n\nSimilar processes exist elsewhere in the world. For example, in Europe approval is obtained via a Clinical Trial Application (CTA).\nOther Info to Think About When Joining a Study: If you join a study that is testing a medicine under an Investigational New Drug (IND) application you should feel free to ask about what safety information about the study treatment is already known, and why this particular medicine is being tested. You can also find out more about the risks and what kind of care you can expect to receive if there are any adverse events.\nRelated Terms: investigational medicine\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/investigational-new-drug-ind-application/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C96090\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "investigational product", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: investigational product\nGlossary Definition: A drug, device, vaccine, or other treatment being tested in a study.\nUse in Context: The investigational product is what is studied in a clinical trial.\nMore Info: The Investigational New Drug (IND) application is specific to the United States (US). Researchers testing a new drug, or an approved drug for a new use, must get approval of an IND from the US Food and Drug Administration (FDA). The FDA is a government agency that regulates drugs and devices that are used in patients. Once approval is obtained, the research is often said to be conducted \"under an IND.\"\n\nSimilar processes exist elsewhere in the world. For example, in Europe approval is obtained via a Clinical Trial Application (CTA).\nOther Info to Think About When Joining a Study: If you join a study that is testing a medicine under an Investigational New Drug (IND) application you should feel free to ask about what safety information about the study treatment is already known, and why this particular medicine is being tested. You can also find out more about the risks and what kind of care you can expect to receive if there are any adverse events.\nRelated Terms: investigational treatment, study treatment, intervention\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/investigational-product/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C41161\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "investigator", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: investigator\nGlossary Definition: A person who leads a research study.\nUse in Context: The investigator is responsible for making sure the study is carried out as planned.\nMore Info: A study can have many investigators. An investigator could be a doctor, scientist, or other health professional. \n\nA principal investigator is in charge of making sure the whole research study is being conducted correctly. \nOther Info to Think About When Joining a Study: You may hear the term \"investigator\" when you learn about the different people involved in doing a study. The investigator who is running the study may be listed in the consent form.. \n\nYou can ask for the investigator's name and also find out who you should contact in case you have any problems or questions during the study. It may be someone other than the investigator. \nRelated Terms: researcher, study doctor, principal investigator, sub-investigator, co-investigator, coordinating investigator, site investigator\nOther Resources: https://catalyst.harvard.edu/publications-documents/meet-the-research-team/?ref=true\nTerm URL: https://mrctcenter.org/glossaryterm/investigator/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25936\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "longitudinal study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: longitudinal study\nGlossary Definition: Research that collects data from the same participants over a long time.\nUse in Context: A longitudinal study collects information from a group of participants over a given period of time.\nMore Info: Longitudinal studies help researchers see how specific factors about participants change over time.\n\nLongitudinal studies can be many weeks, months or years, depending on the topic being studied. \n\nFor example, enrolling 3 year old children to see whether a specific early childhood education program affects later learning is a longitudinal study. Another example is finding out whether a study treatment prevents a disease from getting worse over time.\nOther Info to Think About When Joining a Study: If you are considering joining a longitudinal study you should ask questions about how long the commitment is and what will be expected. A research study may have the term \"longitudinal\" in its title or used to describe follow-up study visits.\n\nIf you have questions about how this term is used, ask the study team before deciding to join this study. \nRelated Terms: \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/longitudinal-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C15273\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Magnetic Resonance Imaging (MRI)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Magnetic Resonance Imaging (MRI)\nGlossary Definition: A way to take pictures of the inside of a person\u2019s body with a machine that uses strong magnets and radio waves.\nUse in Context: Magnetic Resonance Imaging (MRI)I is most often used to take pictures of bones, tissues, organs or the brain.\nMore Info: During an MRI, powerful magnets and radio waves are used to create very detailed pictures of the inside of a person's body. MRIs do not involve radiation.\n\nAn MRI may be done as part of screening, or as a way to collect data about a participant throughout the study.\nOther Info to Think About When Joining a Study: You may have heard the term \"MRI\" when talking to your regular doctor. Some research studies may involve getting an MRI. If you have an MRI you will not be exposed to any radiation.\n\nYou can ask why a study is using MRIs. You may also want to know if the study team will share your MRI pictures with you or your regular doctors. In general, MRI research scans are done for the research and not to identify specific health problems. If you have concerns about your health, please discuss them with your regular doctor.\nRelated Terms: imaging study, CT scan, X-ray\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/magnetic-resonance-imaging-mri/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16809\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "master protocol", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: master protocol\nGlossary Definition: An overall research plan that guides sub-studies that have their own research questions\nUse in Context: A master protocol includes information about more than one study and allows the research to happen more quickly.\nMore Info: A Master Protocol is the main protocol that guides sub-studies that can each be done at the same time.\n\nMaster Protocols are used because they can help get answers more quickly and efficiently. They generally need fewer participants and offer more study options. \n\nBasket Trials, Umbrella Trials, and Platform Trials are all types of Master Protocols.\n\nOther Info to Think About When Joining a Study: You may see studies refer to a \"Master Protocol.\"\n\nThese studies will have sub-studies that participants join. You can ask all about how the studies are designed, whether you can choose which sub-study you will be in, and how your experience in one sub-study may be different from other sub-studies.\nRelated Terms: basket trial, umbrella trial, platform trial\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/master-protocol/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C165770\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "maximum", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: maximum\nGlossary Definition: The most or largest amount.\nUse in Context: A study treatment should have the maximum benefit without causing serious side effects.\nMore Info: The word \"maximum\" can refer to anything that is measured. In a study, it may be the \"maximum age\" of participants eligible for the study, or the \"maximum dose\" permitted, or the \"maximum amount of blood\" that may be taken at any one time.\nOther Info to Think About When Joining a Study: You may see the term \"maximum\" used in a variety of different ways. For example, the study team may talk about the maximum dose of a medication you can take. Or they may talk about the maximum number in a range of results from some type of research test.\n\nIf you are unclear about how the study team is using the word, please ask them to explain more.\nRelated Terms: most, largest, greatest\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/maximum/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25564\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "mean", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: mean\nGlossary Definition: The average.\nUse in Context: In math, the mean is the average value of a set of numbers.\nMore Info: The mean is calculated by adding all the numbers in a set together, and dividing by the number of values. \n\nFor example, in a group of four people who are aged 10, 20, 30, and 40, the mean (or average) age of the group members is 25. \n\nThis is calculated by first adding all four numbers together, and then dividing by 4. \n\nSo, 10 + 20 + 30 + 40 = 100. And 100/4 = 25. Thus, the mean, or average age, is 25.\nOther Info to Think About When Joining a Study: You may see the term \"mean\" used to describe an average of all the study data using numbers. You may see this term used in study results reports. \n\nIf you receive study results that report the mean of any data and you have questions about that information, you can reach out to the study team to learn more.\nRelated Terms: average, median\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/mean/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C53319\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "median", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: median\nGlossary Definition: The middle number in a set of numbers when listed in order from lowest to highest.\nUse in Context: In math, the median is the middle number in a set of numbers. \nMore Info: The median is the middle, and it is not the same as the mean or average.\n\nFor example, 5 is the median in the set of numbers 2, 3, 5, 30, and 50, because 5 is in the middle when the numbers are ordered from lowest to highest.\n\nFinding out the median can be useful if there are data that are outside the expected range. In the example above, 5 is the median, and that is far lower than the mean of 18 (that is, 2+3+5+30+50= 90; 90/5=18), showing that the data are not evenly spread out.\nOther Info to Think About When Joining a Study: You might see the term \"median\" used to describe the the middle number in a set of data. You may see this term used in study results reports. \n\nIf you receive study results that report the median of a data set and you have questions about that information, you can reach out to the study team to learn more.\nRelated Terms: middle\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/median/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C28007\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "minimal", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: minimal\nGlossary Definition: Very small. \nUse in Context: A participant must report every adverse reaction even if the impact on their lives seems minimal.\nMore Info: The risks of a study are minimal or very small if they are about the same as the risks of daily living. Adverse events may be described as minimal if they don't last very long or are mild.\n\nSome research is considered to be minimal risk, meaning the risk to participants should not be very high.\nOther Info to Think About When Joining a Study: You may hear the term \"minimal\" when discussing whether a study is minimal risk or not. \n\nIf you have any questions about the risk of the study or otherwise how the word \"minimal\" is being used, you should feel free to discuss it with the study team.\nRelated Terms: limited, negligible\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/minimal/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25570\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "minimum", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: minimum\nGlossary Definition: The smallest or least amount.\nUse in Context: A research study needs a minimum number of participants so enough data can be collected to answer the study questions.\nMore Info: The word \"minimum\" can refer to anything that can be measured. \n\nFor example, in a research study the \"minimum age\" in eligibility criteria is the youngest age that is allowed for a person to be enrolled. \nOther Info to Think About When Joining a Study: The term \"minimum\" may be used in a variety of contexts. For example, the study team share information about the minimum amount of time you have to do a study task. They might also talk about the minimum age for study participants. \n\nIf you are unclear about how the study team is using the word, please ask them to explain more.\nRelated Terms: least, lowest\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/minimum/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25570\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "minor", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: minor\nGlossary Definition: Someone considered too young to give legal consent.\nUse in Context: A minor is a person who is under the legal age of majority in a specific place. \nMore Info: Studies that enroll children need to have processes in place to ensure a parent or a guardian gives consent. The minor, when appropriate, is asked for their agreement before they are enrolled in the study. This is called assent.\nOther Info to Think About When Joining a Study: \u201cMinor\u201d is another word for child or pediatric participant. If you are a parent or guardian with a child who may join a research study, you can ask any questions, such as whether if there is a separate assent process for the child and whether there are additional protections for children.\nRelated Terms: assent, child, young person\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/minor/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C156663\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "monitor", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: monitor\nGlossary Definition: To observe, check or evaluate something in a study over time.\nUse in Context: In ongoing studies, researchers have a responsibility to monitor the study participants.\nMore Info: Participants might have their health and safety monitored depending on what type of study they are in.\n\nData can be monitored as well to make sure they are being collected and stored correctly.\nOther Info to Think About When Joining a Study: The word \"monitor\" is often used to describe the steps and processes that will be followed to make sure participant safety is being protected and the study is being conducted properly.\n\nYou can always ask the study team about how your safety and well-being will be monitored and how the study team will monitor the overall study.\nRelated Terms: audit, investigate, assess, watch, oversee, observe, evaluate\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/monitor/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C61256\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "morbidity (rate)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: morbidity (rate)\nGlossary Definition: The number of people who develop a disease or illness in a group over time.\nUse in Context: The morbidity rate in a study refers to how many people have or develop a condition.\nMore Info: The morbidity rate is calculated by counting how many new cases or illnesses occur in a given number of people in a certain amount of time.\n\nMorbidity can also refer to medical problems caused by a treatment. \n\n For example, if 100 people get a rash from a new medication in a study of 1000 people, the morbidity rate of rash is 10% (e.g., 100/1000=1/10 or 10%).\nOther Info to Think About When Joining a Study: In the clinical research context, the term \"morbidity rate\" can be found in study descriptions. A study could be looking at ways to decrease the number of people developing a disease or illness.\n\nSometimes you might see the term \"morbidity rate\" used in study results as well to describe how many participants develop new diseases or illnesses, or even how the morbidity rate of the study compares with the general public or other groups.\n\nIf you see this term when you are reviewing a research document, you can always ask the study team about how it might be important for your participation in the study.\nRelated Terms: illness rate, mortality\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/morbidity-rate/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C184382\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "mortality (rate)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: mortality (rate)\nGlossary Definition: The number of deaths in a group of people over time.\nUse in Context: The mortality rate in a study refers to how many people died over the course of the study.\nMore Info: The mortality rate is calculated by counting how many deaths occur in a group of people during an amount of time.\n\nFor example, if 6 people died in a study of 200 people, the mortality rate would be 3% (e.g., 6/200=3/100=3%)\nOther Info to Think About When Joining a Study: In the clinical research context, the term \"mortality rate\" can be found in study descriptions. A study may look at ways to decrease the number of deaths (\"mortality rate\") in a group of people or from a specific cause. The term may also be used to describe how many participants died over the course of the study.\n\nIf you see this term when you are reviewing a research document, you can always ask the study team about how it might be important for your participation in the study.\nRelated Terms: death rate, morbidity\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/mortality-rate/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16880\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "multicenter trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: multicenter trial\nGlossary Definition: A study that takes place at more than one research center.\nUse in Context: A multicenter trial can be done in many locations in a country or even around the world.\nMore Info: A multicenter study is a way to conduct research at more than one research center or site to make sure there are enough participants and people from many different backgrounds. A research center can be hospital, clinic, or research institution.\nOther Info to Think About When Joining a Study: You may hear the term \"multicenter study\" when the study team describes what kind of research study you could join or when you are reading the consent form. \n\nIf a study is multi-center, you could ask what the other study locations there are. You may want to clarify who the investigator is at your research center and who to contact if you have questions. \nRelated Terms: multi-site study, investigator\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/multicenter-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16104\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "negative test result", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: negative test result\nGlossary Definition: A test result that shows a person does not have what was tested for.\nUse in Context: A negative COVID test means that the person most likely does not have COVID.\nMore Info: A negative test result for a disease, condition, genetic marker, or biomarker means that a person likely does not have the condition being tested for. \n\nA \"false negative\" means that the test incorrectly found someone to be negative when they are actually positive. Tests try to reduce the number of false negatives. \nOther Info to Think About When Joining a Study: You may see the term \"negative test result\" in the context of study screening or a study procedure. You may want to ask if you will get the test result and if yes, how long it will take for the results to be ready. If you have any questions about this test result you should discuss with the study team.\nRelated Terms: sensitivity, specificity, false negative\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/negative-test-result/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C35681\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "negligible", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: negligible\nGlossary Definition: So small that it has little to no impact.\nUse in Context: Some research results are negligible in terms of what they mean for patient care.\nMore Info: If an event, effect, or result is negligible, it is not considered important or impactful.\nOther Info to Think About When Joining a Study: The word \"negligible\" could be seen in the context of clinical research study results to describe that a difference between data or outcomes is so small that it is unlikely to have an impact on patient care.\nRelated Terms: unimportant, insignificant, inconsequential, minor, minimal\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/negligible/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203922\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "non-compliance", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: non-compliance\nGlossary Definition: Not following research requirements.\nUse in Context: Non-compliance with the research protocol can impact the outcomes of the research.\nMore Info: Non-compliance can apply to either researchers or participants not following the study requirements. Researchers must comply with the laws and regulations of research and the protocol as written. Participants must comply with study procedures. \n\nParticipant non-compliance could result in the principal investigator removing a participant from the study for not following the study instructions.\n\nRegulators, sponsors or the IRB could check a research team for non-compliance with research laws and regulations.\nOther Info to Think About When Joining a Study: You might hear the term \"non-compliance\" when study team tells you about things you should do while in the study in order for the data to be complete. If you do not do these things, non-compliance could be an issue. For example, the study team may say you have to take an investigational medicine 3 times a day. If you only take it twice a day, it would be considered non-compliance with the study procedures. There may also be things you cannot do while you are in the study and if you do them, that is also considered non-compliance. \n\nBefore signing up for a study, be sure to ask for clarification if you are unsure about what you need to do while you are in the study and what you cannot do. You may also want to ask what will happen if you are non-compliant. For example, if you have to take the investigational medicine once a day but you forget to, you can ask the study team what you should do in that situation.\nRelated Terms: \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/non-compliance/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C201294\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "non-inferiority trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: non-inferiority trial\nGlossary Definition: A study to test if a study treatment works about as well as another treatment for the same condition.\nUse in Context: One example of a non-inferiority trial would be to test whether a new medicine for asthma works as well as one that some patients already use.\nMore Info: Non-inferiority trials are done to find more treatment options that work as well as ones that are already approved for a specific disease or condition.\nOther Info to Think About When Joining a Study: If you are considering joining a non-inferiority trial this means that the study will be looking at whether one treatment is as good as another. You should ask the study team any questions you have about the treatments being studied or how you will be assigned to a study arm. \nRelated Terms: non-inferiority study, superiority trial, equivalence trial, control\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/non-inferiority-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C184386\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "objective", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: objective\nGlossary Definition: A purpose or goal of a study.\nUse in Context: The research objective is the scientific question to be answered by the study. \nMore Info: The study protocol always includes the objective(s) of the research. \n\nFor example, an objective could be to find out whether a study treatment causes a certain symptom to get better.\nOther Info to Think About When Joining a Study: You might see the word \"objective\" in the consent form or study protocol. You could also hear about the objectives when speaking with the study team. \n\n The objective of the study refers to what the study is trying to find out. If you participate in a study you should undertsand the objective and ask the study team any questions you might have.\nRelated Terms: study objective aim, goal, purpose\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/objective/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142450\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "observational study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: observational study\nGlossary Definition: A study that collects health information about study participants without giving a treatment. \nUse in Context: In an observational study, data will be collected about each participant but no one will be assigned to get a study treatment.\nMore Info: For example, a study to see whether those who smoke cigarettes report higher rates of lung cancer than those that do not would be an observational study.\n\nData are collected using methods like surveys and lab tests, as well as from other sources like medical records and historical datasets.\nOther Info to Think About When Joining a Study: If you enroll in an observational study this means data will be collected about you but no study treatment will be assigned.\n\nYou may want to ask how the research team will collect data from you during your time in the observational study.\nRelated Terms: natural history study, cohort study, case control study, empirical study\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/observational-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16084\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "observe", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: observe\nGlossary Definition: To watch or see how participants are doing in a study.\nUse in Context: Participants may be observed for a few minutes after taking the study treatment to check for any early adverse reactions.\nMore Info: To observe participants is one way to collect and document data for a study in a planned way.\nOther Info to Think About When Joining a Study: The study consent form or any information the study team gives you about the study you are participating in may mention that you will be observed. This could happen the first time you take an investigational medicine or after you take part in some type of research test. \n\nYou can ask how long you will need to be observed if that is something that will happen to you. For example, after getting a vaccine, you may have to be monitored for some time to make sure you have no reactions.\nRelated Terms: \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/observe/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25599\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "occasionally", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: occasionally\nGlossary Definition: Once in a while.\nUse in Context: Occasionally there are changes in the study that require participants to re-consent to continue.\nMore Info: The protocol and consent form will discuss how often certain procedures or possble harms will happen. If the frequency is described as being ocassionally, it means an event won't happen that often or predictably.\nOther Info to Think About When Joining a Study: The word \"occasionally\" can be used to describe how often an adverse event occurred in a research study.\n\nYou might want to know more about what that frequency could mean if you take a particular study treatment. \nRelated Terms: Sometimes, infrequent, rare\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/occasionally/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C151974\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "odds ratio", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: odds ratio\nGlossary Definition: The chance of a health event happening in one group compared with the chance of the same event happening in another group.\nUse in Context: An odds ratio is a measure of the link between an exposure and an event. \nMore Info: An odds ratio compares the odds of two different groups. It is used to describe the association of exposure to one variable of interest (e.g. health characteristic, aspect of medical history) to a disease or disorder, compared with the lack of the variable with the disease or disorder. It also looks at the strength of that association. \n\nThe odds ratio can also be used to determine whether a specific exposure is a risk factor for a particular outcome. For instance, the ratio of the odds of lung cancer in smokers divided by the odds of lung cancer in non-smokers is 14.\n\nTwo events are not related if the odds ratio equals 1, i.e., the odds of event are the same in either the presence or absence of the other event.\n\nIf the odds ratio is greater than 1, thentwo events are positively associated (correlated) i.e. The presence of one event increases the chance of the other one being present.\nOther Info to Think About When Joining a Study: You may see the term \"odds ratio\" when reading results information of a research study. The results section of a publication will talk about the data and statistics. \"Odds Ratio\" is a technical math term and will not usually be used in materials designed especially for patients and participants. \n\nIf you see this word in a study document for a study you are thinking about joining, enrolled in, or completed, you can ask the researcher or study team any questions you might have.\nRelated Terms: relatedness, relationship\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/odds-ratio/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16932\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "off-label", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: off-label\nGlossary Definition: The use of a treatment in a different way or for a condition other than what it is approved for.\nUse in Context: Doctors can prescribe a medicine or other treatments off-label. \nMore Info: The \"label\" in \"off-label\"refers to the specific, intended use that the medicine or product has been approved for. This approval is given by regulators, health authorities or government agencies. This applies to drugs and devices.\n\nA doctor may prescribe a drug off-label when there is reason to believe that the drug could be helpful when used in a new or different way or for a different condition, as in a different age group, dosage, way to take it, or condition.\nOther Info to Think About When Joining a Study: Some research studies are investigating a treatment that is being given as an \"off-label\" use.\n\nYou can ask the study team what the treatment is approved for and what its intended use is. You may also want to ask why they want to use this treatment off-label and what information they may have that could suggest it would work off-label.\nRelated Terms: off-label use, unapproved, unapproved use, intended use\nOther Resources: \n\nhttps://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label\nTerm URL: https://mrctcenter.org/glossaryterm/off-label/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C125600\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "open-label", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: open-label\nGlossary Definition: A type of study where participants and research staff know which treatment participants are being given.\nUse in Context: When a study treatment is open-label, participants know what they are taking.\nMore Info: Open-label studies are used in a number of settings, including to learn about the long-term effects of study treatments. Sometimes it is impossible to mask which treatment a person will receive. Sometimes participants who have finished the treatment part of the stud keep sharing data so researchers can see how long the effects of treatment last.\nOther Info to Think About When Joining a Study: Some research studies are investigating a treatment that is being given open-label, without masking what the participant is receiving.\n\nIf you are participating in a research study that is testing a study treatment, you can ask the study team whether you will be able to continue taking the treatment as an open-label use.\nRelated Terms: unblinded, unmasked\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/open-label/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C49659\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "outcome (of study)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: outcome (of study)\nGlossary Definition: A description of the overall results of the study.\nUse in Context: The study outcome describes what the researchers learned from the research.\nMore Info: The study outcome will report the study results, such as whether or not a study treatment helped participants.\nOther Info to Think About When Joining a Study: You might see the word \"outcome\" when you read about a research study's results and the overall conclusions that researchers came to based on the study data.\n\nIf you have any questions about the outcome of the study and what a study's results mean for you, you can ask the study team or discuss with your regular doctor.\nRelated Terms: result, endpoint, primary endpoint, surrogate, secondary endpoint, clinical endpoint\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/outcome-of-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C204098\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "outcome measure", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: outcome measure\nGlossary Definition: The way that a study endpoint is measured.\nUse in Context: An outcome measure is used to collect data for the study.\nMore Info: A study will use one or more outcome measures to collect the data that is needed to answer the research questions. For example, an outcome measure could be a blood test to find out how well the study treatment works to lower cholesterol.\nOther Info to Think About When Joining a Study: An outcome measure can be a questionnaire, survey, or any kind of assessment that is done to see any changes over the course of the study. Example of assessments include blood test, blood pressure reading, MRI, etc.\n\n If you have any questions about the outcome measures being used in a study, feel free to ask the study team.\nRelated Terms: questionnaire, assessment, survey, data, endpoint\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/outcome-measure/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C93407\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "p-value (probability value)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: p-value (probability value)\nGlossary Definition: A number that researchers use to show that a result did not occur by chance.\nUse in Context: The p-value is used in research to show whether a difference in effect between treatments is due to chance.\nMore Info: The p-value is part of the scientific process. It is a number used when analyzing research data and reporting research results. \n\nThe p-value shows whether the results could have occurred by chance.\n\nWhen a p-value is very small, it means that it is less likely to have occurred by chance.\n\nFor example, if a study has a p-value of 0.05, this means that if you did the study 100 times, the results would likely be the same 95 times. \n\nIt is important to note that even if something has a small p-value and is statistically significant, the result may not make a big difference to patients. For example, a drug may shrink a tumor but not extend a person's life.\nOther Info to Think About When Joining a Study: You might see the term \"p value\" in a publication about research where the study results and statistics are reported.\n\nThe article may include a results section that has more information about what the p-value for the study is and what that means for the results.\n\nThe p-value could also come up in Plain Language Summaries of a study's results\n\nIf you have any questions about how the p-value is being reported, feel free to talk to the study team.\nRelated Terms: statistically significant\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/p-value-probability-value/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C44185\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "participate", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: participate\nGlossary Definition: To take part in a study.\nUse in Context: By signing the consent form, a person agrees to participate in the study.\nMore Info: To participate in a study is voluntary. \n\nBefore agreeing to participate in a study, a person should know what the study procedures will be. \n\nA person can always withdraw from a study if they decide that they no longer want to participate. \n\nBefore doing so, the participant should have a conversation with the study team. \nOther Info to Think About When Joining a Study: Your doctor may ask you if you want to participate in a study. Additionally, during the consent process, a person from the study team will make sure you want to participate in the study before joining. \n\nYou could ask about the benefits and risks if you participate in the study. It will also be important for you to know what the study procedures are when you participate in this study.\nRelated Terms: join, be a part of, volunteer\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/participate/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203923\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Patient Reported Outcomes (PROs)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Patient Reported Outcomes (PROs)\nGlossary Definition: The information that patients share about their own health or well-being to answer questions in a study.\nUse in Context: Patient Reported Outcomes are a way to hear directly from patients about their health or study experience.\nMore Info: Measures to collect Patient Reported Outcomes (PROs) includes how a participant feels during the study, such as mood, sleepiness, amount of pain, and adverse events. Participants can explain how the disease or the study treatment is affecting their ability to do things like exercising, sleeping, going to work, etc.\n\nPROs might be collected with surveys, questionnaires, diaries, or interviews. \n\nPROs are important because they allow patients to report directly how they feel, and not as observed by the doctor, researcher, or someone else. \n\nPROs can often measure what is important to participants. Analyzing the data allows researchers to draw some conclusions about the outcome.\nOther Info to Think About When Joining a Study: A study you decide to participate in may involve collecting patient reported outcomes (PROs). This may be listed in the consent form as something you need to do if you enroll in a study. \n\nYou may wish to ask how PROs will be collected because it could be from surveys, interviews, diary entries or another way not mentioned here. You may also want to clarify how much detail they want when you provide these answers. \n\nMost PROs are not reviewed in real time so participants should not expect to hear back from the study staff about what was entered.\nRelated Terms: Patient Reported Outcome Measure (PROM)\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/patient-reported-outcomes-pros/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C95401\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "peer review", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: peer review\nGlossary Definition: Evaluation by independent experts.\nUse in Context: Medical journal articles and grant applications often go through a peer review process.\nMore Info: Peer review involves a critical assessment of the ethics, methods, conduct, analysis, and reporting of research by other experts in the field. Peer review is done by people who are independent and not involved in the research study conduct.\n\nA peer review process helps maintain rigor, independence, validity, standards and integrity of research studies. \n\nA peer review process asks \"Does the content we are reviewing meet the expected quality and standard?\"\nOther Info to Think About When Joining a Study: You could hear about scientific journal articles going through a \"peer review\" process before they can be published. Many scientific journals that report research results include a peer review step to make sure the information is shared publicly.\nRelated Terms: \nOther Resources: \n\nhttps://www.nlm.nih.gov/nichsr/stats_tutorial/section3/mod6_peer.html\nTerm URL: https://mrctcenter.org/glossaryterm/peer-review/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C16963\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "periodically", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: periodically\nGlossary Definition: At regular or expected times.\nUse in Context: The study staff checks in with participants periodically to see how they are feeling.\nMore Info: When something happens periodically, it usually means that it happens on a schedule and is expected.\nOther Info to Think About When Joining a Study: The word \"periodically\" could be used to describe how the study is monitored or how often some sort of event could happen.\n\nIf something in the study materials is described as \"periodically,\" you may want to ask the study team what that timing will mean for you as a participant in the study.\nRelated Terms: scheduled, regularly, repeatedly\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/periodically/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203924\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Pharmacodynamic (PD) study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Pharmacodynamic (PD) study\nGlossary Definition: A study that measures the effects of a drug on the human body.\nUse in Context: During a pharmacodynamic study a participant will have their blood and other body fluids collected a few times over a few hours to see how the dose of the study treatment affects their body.\nMore Info: A pharmacodynamic (PD) study is the study of the effects of the drug on the human body. A PD study helps researchers learn whether the study treatment is having the desired effect on the body, and how the dose of the drug affects the response. For example, a PD study could try to find out if a drug for cancer will attach to a cancer cell and lead to the cell's death.\nOther Info to Think About When Joining a Study: You might see the term \"pharmacodynamic study\", when researchers want to find out what effect the drug has on participants' bodies and how their bodies react. This is different from a pharmacokinetic study where the effect of the body on the drug is measured. Researchers use this information to design clinical trials, for example, what doses to give to participants. Because of this, pharmacodynamic studies are usually conducted early in the research process to help guide what is the best dosage for humans to take and to also look at safety in general. \n\nIf you are considering participating in a pharmacodynamic study you can ask the researchers about what is already known about the drug, and how the study team will be monitoring the safety of the participants.\nRelated Terms: Pharmacokinetic (PK) study\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/pharmacodynamic-pd-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C49662\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Pharmacokinetic (PK) study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Pharmacokinetic (PK) study\nGlossary Definition: A study that measures what happens to a drug in a person\u2019s body over time.\nUse in Context: A pharmacokinetic study often enrolls healthy volunteers first before other participants.\nMore Info: A pharmacokinetic study means that a participant will have a blood draw and possibly other body fluids taken a few times over a few hours to see how the study treatment was used by the body. \n \nThe PK study is done to find out how a drug is absorbed, moves through, is broken down, and exits the body.\nOther Info to Think About When Joining a Study: If you enroll in a pharmacokinetic study a drug or medicine will be given to you and then blood samples will be taken several times over several hours to see how the study treatment was processed by your body. \n\nIf you have any questions about the drug or medicine being tested or how long the pharmacokinetic study will take, you could discuss them with the study team.\nRelated Terms: Pharmacodynamic (PD) studies\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/pharmacokinetic-pk-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C15299\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "pharmacovigilance", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: pharmacovigilance\nGlossary Definition: A process to detect, review, and make decisions about drug safety to protect patients.\nUse in Context: Scientific drug safety monitoring is called pharmacovigilance.\nMore Info: \n\nPharmacovigilance is the science of monitoring the effects of drugs and vaccines. It involves detecting, understanding, and preventing adverse events and determining whether observed events are caused by the drug or vaccine.\n\nPharmacovigilance happens during and after a research study, and after a drug is approved\nOther Info to Think About When Joining a Study: The word \"pharmacovigilance\" is sometimes used in conversations about the risk and safety monitoring of a drug.\n\nIf you see this word and have any questions about how it is being used, you should ask the study team.\nRelated Terms: drug safety\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/pharmacovigilance/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142637\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "phase", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: phase\nGlossary Definition: A step in the overall clinical research process to test a new drug, device, or treatment.\nUse in Context: Research is done in phases to make sure a study treatment is safe and then whether it works before it is approved.\nMore Info: A phase is a step in the research process. Phases of research studies build on each other and each phase has a separate goal. \n \nPhase 1 studies are usually the first to enroll humans and test for safety. \n \n Phase 2 studies test if the drug, device or treatment works. \n \n Phase 3 studies compare the study treatment to the usual, standard treatment. \n \nPhase 4 studies continue to collect data after a study treatment is approved. These are sometimes called post-marketing studies.\nOther Info to Think About When Joining a Study: You may see the term \"phase\" when you are reading about clinical trials. \n\nBefore you enroll in a clinical trial you may want to ask about what phase the study is in. You may also want to know more about the information the study team already has about the risks and benefits of the study treatment that is being tested.\nRelated Terms: clinical research, clinical trial, preclinical study\nOther Resources: \n\nhttps://www.fda.gov/patients/drug-development-process/step-3-clinical-research\nTerm URL: https://mrctcenter.org/glossaryterm/phase/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C48281\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "pilot study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: pilot study\nGlossary Definition: A small study that is done to test a process before starting a larger study.\nUse in Context: A pilot study is a way to detect and fix problems in the study process or to test a specific idea.\nMore Info: A pilot study enrolls a limited number of participants to discover the best ways to conduct a larger study.\nOther Info to Think About When Joining a Study: A \"pilot study\" may test whether an intervention works well enough to continue studying it. Other times, a pilot study could be testing how the study treatment works in the body or the safety and participant experience of a product. You may want to ask if other studies have been done and their results, and about the risks and safety of the study treatment.\n\nRelated Terms: Proof of principle; Proof of concept; Exploratory; First-in-Human\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/pilot-study/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C15303\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "placebo", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: placebo\nGlossary Definition: Something that looks like the treatment being studied, but doesn't contain any medicine \nUse in Context: Using a placebo in a research study keeps the participant and study doctor from knowing who is receiving the active treatment.\nMore Info: A placebo is made to look, taste and smell like the active treatment being studied. Depending on the study, a placebo can also refer to a device or sham surgery. A placebo helps the researcher see whether the active study treatment really works. Using a placebo reduces bias. \n\nUsing a placebo in a research study is accepted when the risk of not treating a condition is small or when there is no effective standard of care to compare to. \nOther Info to Think About When Joining a Study: When describing the plan of the study, the study team or consent form will say whether or not therea placebo is being used in the study. When a placebo is included in a study, the participants will usually be assigned the placebo through \"randomization.\" This means that whether or not you get the placebo will happen by chance, like flipping a coin. \n\nYou should feel free to ask if there is a chance you could be taking a placebo in the study. You can also ask if you will find out if you are on the placebo at the end of the study. It may also be important for you to ask how they will notify your regular doctors if you are on the placebo or taking an active study treatment if there is a medical need to know.\nRelated Terms: sham substance, sham surgery, control group, sugar pill\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/placebo/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C753\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "placebo-controlled study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: placebo-controlled study\nGlossary Definition: A study with two or more groups where one group is given a placebo.\nUse in Context: Placebo-controlled trials are done to show how the study treatment performs compared to those not receiving the study treatment\nMore Info: A placebo-controlled study compares an active treatment to something that made to look, taste and smell like the active treatment. Using a placebo helps the researcher see whether the active study treatment really works. \n\nPlacebo-controlled trials are usually only done when the risk of not offering an active treatment for a condition is small or when there is no effective standard of care to use as the comparison. \n\n\n\nOther Info to Think About When Joining a Study: You will see the term \"placebo-controlled study\" if the research is using a placebo as a control group.\n\nIf you are considering joining a study that has a placebo, you can ask how the researchers decide who gets the placebo. You can also ask if the study team will tell you what you were taking at the end of the study. You can also ask how the researchers will notify your own doctor about what you are taking in the study if there is a medical reason to know.\nRelated Terms: \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/placebo-controlled-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203925\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "platform trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: platform trial\nGlossary Definition: A research study that tests and compares two or more study treatments for a disease or condition, with study treatment groups being added or removed during the study period.\nUse in Context: A platform trial is an efficient way to compare many study treatments at the same time.\nMore Info: A platform trial is a type of randomized controlled trial (RCT). It is sometimes called a Master Protocol. This is because a platform trial uses Master Protocol to test the different study treatments in the same way, using the same design. \n\nA platform trial is done to compare multiple treatments or interventions by comparing them against each other and a control.\n\nThis is a way to do research more efficiently with fewer patients to find an answer. As a platform trial progresses, the research team may add new study treatments to compare and remove ones that are not working or have too many adverse events. \nOther Info to Think About When Joining a Study: \nYou may hear about platform trials when you are learning about different types of study designs.\n\nIf you are unsure about what it means for a research study to be a platform trial, you should ask a member of the study team to clarify any of your questions.\n\nRelated Terms: master protocol, basket trial, umbrella trial\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/platform-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C209468\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "positive test result", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: positive test result\nGlossary Definition: A test result that shows a person has what was tested for.\nUse in Context: A positive COVID test means that the person most likely has COVID.\nMore Info: A positive test result for a disease, condition, genetic marker, or biomarker means that a person is likely to have or to have had the condition.\n\nA \"false positive\" means that the test incorrectly found someone to be positive when they are actually negative. Tests try to reduce the number of false positives.\nOther Info to Think About When Joining a Study: You may see the term \"positive test result\" in the context of study screening or a study procedure. You may want to ask if you will get the test result and if yes, how long it will take for the results to be ready. If you have any questions about the test result you should discuss with the study team.\nRelated Terms: sensitivity, specificity, false positive\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/positive-test-result/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C38758\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "post-market surveillance", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: post-market surveillance\nGlossary Definition: Continuing to collect and analyze information about the risks and benefits of medicine and devices after they have been approved for patient use.\nUse in Context: Post-market surveillance means that the risks and benefits of medicines and devices are being reviewed after the product has been approved for use.\nMore Info: Post-market surveillance happens after a drug or device has received approval by a goverment health authority.\n\nIt can be done by safety reporting, regular monitoring, or a research study.\n\nOther Info to Think About When Joining a Study: All prescribed and marketed drugs and devices are monitored for safety, termed \"post-market surveillance.\" If you have questions about their safety, you should speak with a member of your usual healthcare team. You may also want to ask how you will be notified if any issues are identified in a drug or device you are using.\nRelated Terms: pharmacovigilance, monitoring, phase 4 studies, post-marketing studies\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/post-market-surveillance/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C142640\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "post-trial access", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: post-trial access\nGlossary Definition: When participants can still receive a study treatment after their participation has ended.\nUse in Context: Participants should find out if they will have post-trial access to the study treatment.\nMore Info: Post-trial access applies to drugs and devices.\n\nWhether and how participants will be able to receive a study treatment usually comes up when the treatment has not yet been approved/certified and there are few or no alternatives.\nOther Info to Think About When Joining a Study: You might see the term \"post-trial access\" while reading a research consent form. It could be helpful to know whether or not you will be able to still take the study treatment after your time in the study is over.\n\nIf you are confused about what is being offered post-trial, be sure to ask the study team. If there is no mention of post-trial access, you should still ask the study team if there are plans to give you the investigational product after your participation in the study has ended.\nRelated Terms: continued access\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/post-trial-access/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C187706\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "preclinical study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: preclinical study\nGlossary Definition: A study to test a treatment in the lab or in animals before testing it in people.\nUse in Context: A preclinical study is done to make sure the study treatment is safe enough to give to people.\nMore Info: If a study treatment has gone through preclinical studies, it means there was lab or animal testing before it was found to be safe enough to give to humans in a clinical trial.\nOther Info to Think About When Joining a Study: Most studies involving investigational products are designed based on data from other studies, including preclinical studies.\n\nIf you are thinking about joining a clinical trial, you can ask about the results of the preclinical studies and why the research team thinks this investigational product can be used in humans.\nRelated Terms: \nOther Resources: \n\nhttps://www.fda.gov/patients/drug-development-process/step-2-preclinical-research \nTerm URL: https://mrctcenter.org/glossaryterm/preclinical-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142642\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "prevalence", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: prevalence\nGlossary Definition: Number of known cases or events in a group.\nUse in Context: The prevalence tells us how many people in a population have a specific disease or condition.\nMore Info: Measuring the prevalence of a health issue is a way to understand how many people are affected in a given time period. It measures how common the condition or disease is, regardless of when the person developed the condition or disease.\n\nFor example, in 2021, the prevalence of diabetes in the US was 11.6% of the population, and 14.7% of all adults (i.e., people aged 18 and older).\nOther Info to Think About When Joining a Study: The term \"prevalence\" is used to describe how many people are known to have a particular disease or condition. \n\nYou may want to ask the study team what the prevalence of adverse events in past studies was. \nRelated Terms: frequency, rate, see also incidence\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/prevalence/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C17010\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "primary endpoint", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: primary endpoint\nGlossary Definition: A study measure that is used to answer the main research question.\nUse in Context: The primary endpoint is the main purpose of the study.\nMore Info: A primary endpoint is how the main research question will be answered. A study is designed to assess the primary endpoint. A study may also have secondary endpoints.\nOther Info to Think About When Joining a Study: \n\nYou may see the concept of the \"primary endpoint\" written about in the consent form or hear about it from the study team. Additionally, if you visit a research study registry (like www.clinicaltrials.gov) you may see studies describe primary and secondary endpoints. The primary endpoint is the main thing the study is measuring. \n\nIf you are enrolling in a study and have any questions about what the main goal of the study is, please ask the study team.\n\nAfter a research study is done and publications are released, you may also read about different types of endpoints. \nRelated Terms: primary aim, outcome, outcome measure\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/primary-endpoint/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C94496\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "probability", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: probability\nGlossary Definition: The likelihood or chance that something might happen.\nUse in Context: The informed consent process should include information about the probability of adverse events.\nMore Info: Probability is also used to describe the likelihood of a risk factor or exposure leading to a condition or disease, for example, what the probability of developing lung cancer is after smoking cigarettes.\nOther Info to Think About When Joining a Study: You may see the term \"probability\" used to describe the chance that you will be assigned into one group or another in the study (randomization). You may also see this term when discussing how likely a risk or adverse event might happen.\n\nWhen you see this term, it might be helpful to ask what the probability means for you as a participant in the study or if you are taking a particular treatment. For example: What is the probability that you will get one study treatment over another? What is the probability of a particular risk happening to you?\nRelated Terms: chance, odds, likelihood, possibility\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/probability/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C54154\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "procedures (for participants)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: procedures (for participants)\nGlossary Definition: The activities that participants will be asked to do during the research study.\nUse in Context: The procedures listed in the consent form include all of the activities that participants will do while they are in the study.\nMore Info: Study procedures are all the ways that the researchers collect data and samples from participants. \n\nCommon procedures include interviews, surveys, blood draws, X-rays and scans, and taking a study treatment. \n\nThe procedures that impact participants will all be listed in the consent form (for example, study visits, blood draws, filling out questionnaires, etc). Other study procedures that the study team has to do are listed in the protocol (for example, data collection and entry).\nOther Info to Think About When Joining a Study: The consent form will list the \"procedures required for a study.\" The procedures describes how many visits there are and what study activities will happen at each visit. The study team should review these with you and answer any questions you have. \nRelated Terms: schedule of assessments, schedule of activities\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/procedures-for-participants/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C98769\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "progression-free survival", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: progression-free survival\nGlossary Definition: The length of time without a person's illness getting worse. \nUse in Context: Some studies look at progression-free survival to see whether a drug helps keep the disease from getting worse.\nMore Info: Progression-free survival is often used to assess the treatment of diseases that are slow-growing and difficult to cure.\n\nWhether a disease is getting worse is measured via procedures such as scans, test results, biomarkers, self-report, etc.\nOther Info to Think About When Joining a Study: Depending on the kind of study you are considering or reading about, you may see or hear references to \"progression-free survival\" during the informed consent process or other informational study materials. \n\n\"Progression-free survival\" may be used to explain the purpose of a study or explain the reason for particular procedures and tests. For example, a study could be collecting data on how long a person lives without the illness getting worse.\n\nIf you have any questions about what it means for a study to look at progression-free survival, you should ask the study team.\nRelated Terms: disease-free survival\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/progression-free-survival/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C28234\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "prospective study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: prospective study\nGlossary Definition: Research that uses new data collected from participants.\nUse in Context: Prospective studies actively collect new data from participants.\nMore Info: A prospective study collects new data over time. \n\nFor example, a lung cancer study might compare two treatments to see if one works better than the other to shrink a tumor.\nOther Info to Think About When Joining a Study: The word \"prospective\" is often used to describe the timing of when a study's data are being collected. A prospective study collects data moving forward. It can be helpful to confirm the schedule with the study team.\nRelated Terms: forward-looking study, real time study\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/prospective-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142646\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "protocol", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: protocol\nGlossary Definition: A complete description of the research plan and procedures.\nUse in Context: The protocol is like a recipe to make sure the research study is done in the same way by all of the study team members.\nMore Info: A protocol is shared among study team members and approved by an institutional review board (IRB) to ensure that the study procedures are conducted consistently. Participants do not usually get to review the complete protocol but its content will be discussed during the informed consent conversation and at study visits.\nOther Info to Think About When Joining a Study: You may learn about the term \"protocol\" from the study team or in the consent form. \n\nThe protocol could be discussed when the study team talks about the instructions they have to to follow to run the study. \n\nAlthough the protocol is not always shared direvtly with participants, may the study protocol on trial registration sites like www.clinicaltrials.gov. \n\n Feel free to ask the study team any questions you have about the study protocol.\nRelated Terms: study protocol, research protocol, consent form, informed consent\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/protocol/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142451\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "proxy", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: proxy\nGlossary Definition: A person who is legally allowed to make research decisions for someone else.\nUse in Context: A proxy has legal permission to choose whether someone who cannot give informed consent on their own should be in a study.\nMore Info: A proxy can be a legal guardian or legally authorized representative (LAR). \n\nA proxy can make decisions based on the wishes or best interests of the potential participant.\n\nA proxy is permitted to sign a consent form on behalf of the study participant.\nOther Info to Think About When Joining a Study: You may see or hear the word \"proxy\" used in cases when participants who are legally not able to make research decisions for themselves are being recruited into a study. For example, a proxy might be needed in a situation where someone has a head injury or is so sick that that they are not able to talk or sign the consent form.\n\nIf you are a proxy for someone else, feel free to ask the study team any questions you have about the research study.\n\n\nRelated Terms: guardian, legally authorized representative\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/proxy/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C119264\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "pseudonymized", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: pseudonymized\nGlossary Definition: Replace personal details with a code so that data are protected.\nUse in Context: To pseudonymize data means that all direct identifiers such as name, birthdate, or address have been replaced with a code. \nMore Info: Researchers pseudonymize data to mask the identify of a specific participant. This also protects participants' personal information from anyone who does not have a research-related reason to know. \n\nWhen data are pseudonymized, identifiable information is replaced with a code to protect their identity. For example, a person's name might be changed to a code like 14252. \n\nIn some cases, researchers keep the code linking back to the participant for returning results or seeking additional information, but they do not share that code.\nOther Info to Think About When Joining a Study: You may see the word \u201cpseudonymize\u201d used in the consent form to describe how data collected in the study will be protected. Researchers are required to make sure that no personally identifiable information is ever released outside of the study to people who should not have access. If you have any questions about how your data will be protected, please feel free to ask the study team.\nRelated Terms: coded, anonymized\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/pseudonymized/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142654\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "purpose", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: purpose\nGlossary Definition: What the study is testing.\nUse in Context: The purpose of research is to answer a scientific question.\nMore Info: The consent form always includes a description of the purpose of the study.\n\nThe purpose is also described in the protocol.\nOther Info to Think About When Joining a Study: If you are a proxy for someone else, you should consider what would be in their best interest and what they would do if they were able to make the decision on their own.\nRelated Terms: study purpose, objective, aim, goal, rationale, hypothesis, intention\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/purpose/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25634\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Quality of Life (QOL)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Quality of Life (QOL)\nGlossary Definition: How someone feels and functions day to day.\nUse in Context: The goal of measuring participant Quality of Life is to understand how they feel and their mental, physical, and social well-being.\nMore Info: Quality of Life (QOL) questions look at how someone feels about their life in the context of their culture and values, QOL is also measured in relation to their own goals, expectations, standards, and concerns.\n\nQuality of Life is often based on the person's ability to do or enjoy daily living activities. \n\nFor example, if a person used to take daily walks but no longer is able to, this person's Quality of Life might be impacted negatively. \nOther Info to Think About When Joining a Study: The study team may collect information about your Quality of Life during the study. They may want to compare your Quality of Life before the study and your Quality of Life after you start the study treatment. \n\nQuality of Life may be something you write down yourself using study surveys. This information could also be collected through interviews. \n\nYou could ask the study team to list out specific things that you may want to consider when thinking about your own Quality of Life. \nRelated Terms: assessment of daily living, Patient Reported Outcome (PRO), Quality Adjusted Life Year (QALY)\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/quality-of-life-qol/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C17047\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "questionnaire", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: questionnaire\nGlossary Definition: A list of questions for study participants to answer as part of the study.\nUse in Context: A questionnaire is one way researchers can collect data.\nMore Info: A questionnaire could be used to find out if a person is eligible to take part in the study, to see how someone is feeling, or to measure the effects of an intervention. \n \n A questionnaire could be online or on paper.\nOther Info to Think About When Joining a Study: A questionnaire or multiple questionnaires may need to be completed over the course of your participation in the study. This may be something you do by yourself or someone on the research team may do it with you. \n\nAs with any study procedure, you can ask what the purpose of the questionnaire is and if it has to be completed all at once.\nRelated Terms: survey, assessment, data\nOther Resources: \n\nhttps://www.youtube.com/watch?v=0LklWXCOawE \nTerm URL: https://mrctcenter.org/glossaryterm/questionnaire/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C17048\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "randomization", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: randomization\nGlossary Definition: A way to use chance to place study participants into different study treatment groups.\nUse in Context: Study randomization is often done using a computer program to decide which group a participant is put into.\nMore Info: Randomization helps make sure the study groups are similar so they can be compared against each other at the end of the study. This is a way to avoid bias.\n \nEvery participant has a chance to be put into one of the study groups. No one can choose which group a participant is placed in, because it is done by a computer program.\nOther Info to Think About When Joining a Study: Randomization is a common way that is used for participants to be assigned to different treatment groups. You might see the term \"randomization\" in the consent form or other study materials. Randomization means that you can't chooses which study treatment you will get. The study treatment is chosen by chance, like pulling names out of a hat.\n\nIf you are unsure, you should ask if randomization will happen in your study. You can also ask for more information about how the randomization will be completed. \nRelated Terms: random assignment, randomize, randomly assigned, blinded, study arm, bias\nOther Resources: https://www.youtube.com/watch?v=MmpF1zxfQZ8&t=6s\n \nhttps://www.cancer.gov/research/participate/clinical-trials/how-trials-work#randomization-and-bias-in-cancer-clinical-trials\nTerm URL: https://mrctcenter.org/glossaryterm/randomization/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25196\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "randomized controlled trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: randomized controlled trial\nGlossary Definition: Research that uses chance to assign participants into study groups.\nUse in Context: A randomized controlled trial is used to compare two or more groups.\nMore Info: In a randomized controlled trial (RCT), the researchers use a computer program to randomly assign which study treatment each participant receives. The computer program sometimes also randomly chooses the order of the study treatment, depending on the study. \n\nThe process of being randomized is sometimes described like \"flipping a coin\" or \"pulling name out of a hat.\" Randomization ensures that participants are put into different study groups fairly and without bias.\nOther Info to Think About When Joining a Study: \n\nA randomized controlled trial is considered one of the best study designs to find out how well a study treatment works against one or more comparison groups.\n\nIf you are asked to participate in a randomized controlled trial, you may want to find out more about the different study groups, what the control group will be, and how participants will be randomized.\n\nRelated Terms: randomization, control, control group, research bias\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/randomized-controlled-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C46079\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "rationale", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: rationale\nGlossary Definition: The reason why a study, or something in a study, is being done.\nUse in Context: A well-planned research study includes a clear rationale for why the study is necessary and important.\nMore Info: The study rationale explains why the study is important and why the study question must be answered. It can include background information, study details, and relevant justifications. \n\nA study without a strong rationale might not be worth doing.\nOther Info to Think About When Joining a Study: You might see the rationale for why a research study is done a certain way being described in the study protocol or consent form. \n\nIt can be helpful to learn more about the rationale of the study before agreeing to participate. Feel free to ask the study team questions about the background of the study and why it is being conducted.\nRelated Terms: reason, explanation, purpose\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/rationale/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C80263\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Real World Data (RWD)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Real World Data (RWD)\nGlossary Definition: Information from many different sources used for health research purposes.\nUse in Context: Real World Data comes from sources like medical records, insurance claims, pharmacies, and wearables such as smart phones or heart monitors set up for that purpose. \nMore Info: Real World Data are routinely collected and not specifically for research. \n\nSome studies use Real World Data such as health information in electronic medical records or insurance claims to learn more about side effects of medicines.\nOther Info to Think About When Joining a Study: Some research studies use Real World Data. You may see the term \"Real World Data\" mentioned in a consent form or described in study results.\n\nIf a study uses Real World Data, you can also ask how these data are collected and protected.\nRelated Terms: data\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/real-world-data-rwd/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C165830\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Real World Evidence (RWE)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Real World Evidence (RWE)\nGlossary Definition: Findings from analyzing Real World Data.\nUse in Context: Real World Evidence comes from analyzing data that are collected from routine sources like medical records and health insurance claims.\nMore Info: Real World Evidence is often used to understand how medicines work in the real world, not in a clinical trial.\n\nReal World Evidence uses routinely collected Real World Data to answer a study question. For example, Real World Evidence can show whether a drug is effective for a given population or subgroup of people based on the number of doctor's visits they need after taking the drug.\nOther Info to Think About When Joining a Study: You may see the term \"real world evidence\" in research results or study summaries, to describe how the data collected from \"real world\" sources prove a particular point or supports a certain conclusion. For example, data taken from insurance claims may provide evidence that one kind of treatment reduces hospital readmissions more than a different treatment.\nRelated Terms: Real World Data (RWD)\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/real-world-evidence-rwe/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C165831\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "registry (study)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: registry (study)\nGlossary Definition: An organized list of research information.\nUse in Context: A clinical trial registry is a place to search for research studies.\nMore Info: Organized lists of information are valuable to research so many types of registries exist. \n\nA medicine or research registry has many different types of information for different uses. \n\nOne example is a clinical trial registry which can include information about research studies that are planned, enrolling, or completed. Some registries also include research results.\n\nA patient registry might be set up by a hospital or health system to allow their community members to express interest in volunteering for research so they can be contacted for participation when a new study is being offered. \n\nA disease registry, like a cancer registry, is a resource to hold specific information about people with a certain disease. Some disease registries allow those who are registered to indicate they are interested in research. Some disease registries just allow researchers to conduct research using the information in the registry.\nOther Info to Think About When Joining a Study: Before you consent to join a research-related registry, you may want to find out more about what information about you will be collected, how your information will be used, and how your privacy will be protected.\n\nThere are also other types of registries too that don't include any of your personal information \n\nFor example, some studies that are funded with money from the USA government are required to post information about the study and its results on a research registry called www.clinicaltrials.gov. You may see a reference to www.clinicaltrials.gov in the consent form if the study team plans to release the overall study results there. \nRelated Terms: clinical trial registry, Patient registry, Participant registry, disease registry\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/registry-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C93453\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "reimburse", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: reimburse\nGlossary Definition: Pay money back to participants for their out-of-pocket study costs.\nUse in Context: Some studies will reimburse for parking, transportation, and other costs of participation.\nMore Info: Participants in research should find out whether the study team will reimburse any personal costs that might arise because of being in the study. \nOther Info to Think About When Joining a Study: When the study team is providing information about what will happen if you participate in the study, they may say if they will reimburse you.\n\nYou can ask if the study team will reimburse you for out-of-pocket costs related to participating in the study. For example, if you have to pay for parking at the study site, you can ask if the study team pay you back for that cost. Find out what out-of-pocket costs will be reimbursed can be important when deciding whether or not to join a study.\nRelated Terms: repay, compensate, refund, remunerate, to pay someone back\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/reimburse/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C157173\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "relative risk", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: relative risk\nGlossary Definition: The chance of a harmful event happening in one study group compared with another.\nUse in Context: If a relative risk is 1 the chance of an adverse event happening is the same across study groups.\n\nMore Info: For example, if a study finds that 20% of smokers develop lung cancer and 5% of non-smokers develop lung cancer, then we can calculate the relative risk of lung cancer in smokers versus non-smokers as:\n\nRelative Risk = 20%/ 5% = 4\n\nThus, in this example, smokers are 4 times more likely to develop lung cancer than non-smokers.\n\n\nOther Info to Think About When Joining a Study: \nYou may see the term \"relative risk\" used in publications about the data and statistics of a research study. The results section of a publication will report the findings which will often include information about how many participants in one arm experienced a health event or problem versus particpants in a comparison group. In general, however, \"relative risk\" is a technical math term and will not usually be used in materials designed especially for patients and participants. \n\nIf you see this word in a study document for a study you are considering, enrolled in, or completed, you can ask the researcher or study team any questions you might have.\nRelated Terms: risk, absolute risk\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/relative-risk/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C93152\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "repository (research)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: repository (research)\nGlossary Definition: A collection of participant data and samples stored for future research.\nUse in Context: A research repository is a safe way for data and samples to be stored for future research studies.\nMore Info: A research repository stores both data and samples that have been collected with the purpose of being used in the future. Like a database, a research repository has strict rules for protecting and accessing the data and samples that are stored in it. \nOther Info to Think About When Joining a Study: A research study may collect data and/or samples to store in a repository for future use. \n\nIf data or samples will be stored for future use, the informed consent form will ask for your consent. You might want to ask the study team about your privacy is maintained, how the data and samples are protected, who can use them in the future, and for what purpose. It is unlikely you will be contacted in the future how they were used.\nRelated Terms: database, data bank, biobank, collection of information, sample repository\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/repository-research/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203936\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "results (study)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: results (study)\nGlossary Definition: Findings from the study.\nUse in Context: The final results of the study are only available after all data are analyzed.\nMore Info: Study results are based on the data that were collected, analyzed, and interpreted in the study.\n\nAn example of a study result is learning that yoga can decrease low back pain.\n\nStudy participants can ask for the research results. Results can be shared in several ways: In a journal article, in a study summary for participants, or in other types of communication.\nOther Info to Think About When Joining a Study: The term \"results\" may appear in publications after the trial is completed and the study team has used the data collected to come out with their findings.\n\nYou can ask if and how the study team will share results with you when the study ends. If they will share, you can ask if you will get your individual information or if it will be a summary of the overall findings. \n\nYou can also ask if this information will be shared with your regular doctor. \n\nIn general, because research studies can take a long time to complete, it may take a while for study results to be finalized and shared. Feel free to ask about when the study team thinks the final study results will be ready.\nRelated Terms: outcome, conclusions, findings, data\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/results-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203930\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "retrospective study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: retrospective study\nGlossary Definition: Research that uses already existing data.\nUse in Context: Retrospective studies use data that were collected in the past.\nMore Info: A retrospective study looks at the historical data of participants. \n\nFor example, a study of people with cancer might use existing medical records to learn more about possible causes and exposures. \n\nA retrospective study may also use stored specimens or tissue samples that were collected in the past.\nOther Info to Think About When Joining a Study: You may see the term \"retrospective study\" if you are asked to give informed consent for the study team will look through your past medical records. \n\nYou may want to ask them about what information they will be obtaining about you and why, and how your privacy will be protected.\n\n\nRelated Terms: backward-looking study\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/retrospective-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C53312\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "risk-benefit ratio", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: risk-benefit ratio\nGlossary Definition: A comparison of the possible bad and potential good things that could happen if a participant joins a research study.\nUse in Context: It is important to discuss and understand the risk-benefit ratio of a research study before agreeing to participate.\nMore Info: People look at the risk-benefit ratio in different ways. Some may be less willing to accept a risk. Others may decide that the possible benefits are greater than the risks. \n\nFeelings about a study's risk-benefit ratio can differ from person-to-person based on their own experiences, life situation, pre-existing conditions, and concerns.\n\nIt can be helpful for someone who is thinking about joining a study to discuss the risk-benefit ratio with the study team, trusted friends, and family members.\nOther Info to Think About When Joining a Study: The term \"risk-benefit ratio\" is sometimes part of consent forms and consent discussions. It is a way to try to describe how the risks and benefits of the study compare. Thinking about the risk-benefit ratio can help you decide whether the study has enough potential benefits to outweigh the risks of being in the study.\n\nYou can talk to the study team and other trusted people in your life to work through whether or not to join the study, based on the information that is known about the study treatment.\nRelated Terms: risk benefit assessment, risk benefit profile, therapeutic index\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/risk-benefit-ratio/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203928\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "risks of a research study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: risks of a research study\nGlossary Definition: The possible harms of being in a research study.\nUse in Context: Learning about the risks of a research study can help a person decide whether or not to join.\nMore Info: The risks of a research study depend on the study and study procedures. Both the serious and more common risks are listed in the consent form.\n\nA potential participant should talk about the study risks with the study team and others before deciding whether to participate.\n\nSome risks may not be known when a person signs the consent form. The study team will keep the participant updated if important new risks are identified.\n\nSometimes there are also risks to other people to consider so these should also be reviewed and understood. For example, if a study shares genetic information that could impact other family members.\n\nThe chance of a risk happening is sometimes called \"absolute risk.\" The absolute risk is a number that shows how many people might have a specific event happen. In general, \"\"absolute risk\"\" is a technical math term and will not usually be used in materials designed especially for patients and participants. A related word is \"relative risk.\"\nOther Info to Think About When Joining a Study: You might see the term \u201crisks of the research study\u201d when the study team gives you a consent form to review and tells you about the study. They will explain the risks that you may experience if you join the study.\n\nAsk questions about any of the risks you don\u2019t understand before agreeing to take part in a study. Risk may involve harm to the body but it may also include things like risk of stigma if sensitive information that is collected during the study is accidentally shared or accessed by others without permission. \n\nTo learn more about the risks of a research study, you can ask things like:\n\u2013 How much do the researchers know about the risks of the study treatment \u2013 especially if it is new or experimental?\n\u2013 Does the study treatment have FDA approval or oversight?\n\u2013What are the short- or long-term risks, discomforts, or unpleasant side effects? How likely are they to occur, and are any of them severe?\n-What are the researchers doing to decrease risks, discomforts, or unpleasant side effects?\n\u2013 Is there anything a participant could do to minimize their risks during the study?\n\n\nRelated Terms: disadvantages, cons, harms, negative impacts, downsides, adverse effects, side effects\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/risks-of-a-research-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142718\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "sample size", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: sample size\nGlossary Definition: The number of participants in a study or study group.\nUse in Context: A study's sample size should ensure there will be enough participants enrolled to answer the study question.\nMore Info: The sample size must be able to be reached so that the study question can be answered. A statistician helps to calculate the sample size to ensure it is large enough to answer the study question. Sample size is often reported as n = . For example, a study with 100 participants would have its sample size described at n=100.\nOther Info to Think About When Joining a Study: The study team may tell you about the sample size of the study. You may also read about the sample size of the study in the consent form. \n\nYou may want to ask how many people have already enrolled in the study before you agree to join. \n\n\nRelated Terms: population size, target population size, statistician, study population \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/sample-size/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C53190\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "schedule of assessments", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: schedule of assessments\nGlossary Definition: A chart that lists the study activities and when they will happen during a study.\nUse in Context: A schedule of assessments can help participants plan for their study visits.\nMore Info: A schedule of assessments is like a calendar or timeline. The schedule of assessments shows a detailed overview of all the study activities that involve participants and when they will happen. \n\nStudy activities can include blood draws, exams, questionnaires, and other medical tests.\nOther Info to Think About When Joining a Study: If you are thinking about joining a study,you may see a \"schedule of assessments\" in the consent form. Someone from the study team may also provide more details. The study team will want to know if you can make it to all the study visits and if you understand all the activities youhave to do while in the study.\n\nIf the schedule seems confusing, it can be helpful to ask the study team to help answer any questions. Additionally, putting all the activities that you need to do to participate in a study (like study visits or surveys) onto your personal calendar can help you plan.\nRelated Terms: schedule of activities, calendar, timetable, study schema\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/schedule-of-assessments/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142678\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "screening", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: screening\nGlossary Definition: Tests and questions to find out if a person can join a study.\nUse in Context: Screening is done before a person joins the study to see if they meet the study requirements.\nMore Info: Researchers review inclusion and exclusion criteria as part of the screening process to make sure the participants are eligible to join a study. \n\nScreening for research often includes an interview, reviewing a person's medical history, a physical examination, and laboratory tests to learn about the potential participant's health.\n\nThere is also screening that occurs outside of research like having a yearly breast cancer screening and colonoscopies.\nOther Info to Think About When Joining a Study: \n\"Screening\" is a word that is commonly seen in consent forms. There may be some screening questions and medical tests you will complete to see if you meet the study eligibility criteria. \n\nYou can ask what kind of screening the study team will have to do before you can join the study. \nRelated Terms: eligibility criteria, inclusion criteria, exclusion criteria, assessment, study screening, screen failure, medical screening, health screening\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/screening/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C48262\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "secondary endpoint", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: secondary endpoint\nGlossary Definition: A measure used to answer other important questions in the study that are not the main research question.\nUse in Context: A secondary endpoint can provide more information about the effect of the study treatment.\nMore Info: A secondary endpoint can help guide researchers to answer other questions related to the study treatment.\n\nA secondary endpoint can also be exploratory, for example, looking for information that might be useful for a future study.\nOther Info to Think About When Joining a Study: You may see the concept of the \"secondary endpoint\" written about in the consent form or hear about it from the study team. Additionally, if you visit www.clinicaltrials.gov you may see references to primary and secondary endpoints. \n\nSecondary endpoints are other aspects that the study is designed to measure. If you are unsure of what it means, please ask the study team for clarification. After the study is done and publications are released, you may also read about different types of endpoints. \n\nSome studies might only have a primary endpoint and you will not see anything about a secondary endpoint. This is normal.\nRelated Terms: Secondary aim\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/secondary-endpoint/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C139173\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "sensitivity (medical test)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: sensitivity (medical test)\nGlossary Definition: How well a medical test can accurately identify people who have a disease or trait.\nUse in Context: The sensitivity of a test refers to how well it detects a disease when the person actually has the disease.\nMore Info: A medical test that has high sensitivity means it is very good at detecting a disease. If it has low sensitivity it means it is not very good at detecting a disease.\n\nGreater sensitivity leads to a more precise diagnosis.\n\nFor example, a COVID test with high sensitivity means the test is able to detect the infection very well.\nOther Info to Think About When Joining a Study: In clinical research and medicine, the term \"sensitivity\" is used to describe how well a medical test works to find cases of an illness or condition. A test that works well to identify people with an illness or condition is said to be very sensitive.\n\nYou can always ask the study team if you have any questions about the way the term \"sensitivity\" is being used in the study information.\nRelated Terms: specificity, true positive, false negative, false positive\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/sensitivity-medical-test/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C41394\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "sequential", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: sequential\nGlossary Definition: Happening in a specific order.\nUse in Context: Events that occur one after the other are sequential.\nMore Info: Research studies have steps and procedures that must be followed in a specific, sequential order. \nOther Info to Think About When Joining a Study: The word \"sequential\" can be used to describe the order that study activities are conducted.\n\nIf you have any questions about sequential study activities you can ask the study team to better understand.\nRelated Terms: one after the other, consecutive, successive\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/sequential/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C49153\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "Serious Adverse Event (SAE)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: Serious Adverse Event (SAE)\nGlossary Definition: A health issue that happens during a study, and can lead to hospital care, lasting medical problems, life-threatening conditions, or death.\nUse in Context: A Serious Adverse Event in a study is usually something very concerning that was not expected. \nMore Info: Serious Adverse Events (SAEs) are health problems that may result in death, an inpatient hospital stay or longer hospitalization, a life-threatening event, a disability happening, or a birth defect in a baby. An SAE may or may not be related to the study treatment.\n\nThere are sometimes new SAEs that could occur that even the study team does not know about yet. The study staff will collect this information from participants to keep track and figure out if it needs to be included in future study informed consent forms.\n\nIn contrast to a Serious Adverse Event, an \"adverse reaction\" is determined to be related to a study treatment.\n\n\n\n\nOther Info to Think About When Joining a Study: You may learn about potential Serious Adverse Events during the consent process if they are known. You could also learn about them during or after the research study if they are discovered later. \n\nWhen you are in a research study, it is important to contact the study team if you have any new health problems whether or not they are serious. This is important for your safety and allows the study team to also monitor the other study participants. You can ask about adverse events, and Serious Adverse Events, before joining or during a study.\nRelated Terms: adverse event, adverse reaction, side effect, dangerous event, life-threatening event, unanticipated problem\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/serious-adverse-event-sae/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C41335\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "side effect", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: side effect\nGlossary Definition: A health change that is not the intended effect of the treatment and usually considered a problem.\nUse in Context: A side effect is not the main effect of the treatment.\nMore Info: Side effects are things that are known to be a possible effect of a treatment. \n\nFor example, a side effect of taking aspirin is excess bleeding. Often times, a side effect is unwanted, but in some cases a side effect could be considereda good thing.\nOther Info to Think About When Joining a Study: Known side effects are listed in the consent form. A member of the study team may also tell you about possible side effects. \n\nAsk any questions about the side effects and how likely they are. You can also ask what you should do if you think you are getting a side effect and who you should tell.\nRelated Terms: health effect, adverse reaction\nOther Resources: \n https://www.fda.gov/drugs/information-consumers-and-patients-drugs/finding-and-learning-about-side-effects-adverse-reactions \nTerm URL: https://mrctcenter.org/glossaryterm/side-effect/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C2861\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "single-blind study", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: single-blind study\nGlossary Definition: A study that is set up so that the study treatment each participant receives is not known by the participants but is known by the researchers.\nUse in Context: A participant in a single-blind study will not know which study group they are in, but the study doctor will.\nMore Info: Some studies are single-blind because participants knowing which treatment they are getting can affect the results of the study, through a concept called bias. \n\nBias can occur when participants know which study group they are in.\n \nParticipants can ask to find out which study treatment they received after the study ends.\nOther Info to Think About When Joining a Study: The term \"single-blind study\" refers to how a study was designed. This means that the researcher will know what study treatment each participant received but the participant won't.\n\nYou can always ask the researchers why the study is done as a single-blind study. You could also ask if and when you will find out what study treatment you were given.\nRelated Terms: masked/masking, bias, double-blind study, randomization\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/single-blind-study/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C28233\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "specificity (medical test)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: specificity (medical test)\nGlossary Definition: How well a medical test can accurately identify people who do not have a disease or trait.\nUse in Context: The specificity of a test refers to how well it identifies when an illness is not present.\nMore Info: A medical test that has high specificity means it is very good at detecting if a person does not have a disease. If it has low specificity it identifies people as having the disease when they actually do not.\n\nGreater specificity allows people who do not have a condition to be identified and screened out so resources can be put toward caring for people who do have the condition.\n\nFor example, a COVID test with high specificity means the test correctly identifies when people don't have the infection.\nOther Info to Think About When Joining a Study: In clinical research and medicine, the term \"specificity\" is used to describe how well a medical test works to show people who do not have an illness or condition. A test that works well to rule out people who do not have an illness or condition is said to be very specific.\n\nYou can always ask the study team if you have any questions about the way the term \"specificity\" is being used in the study information.\nRelated Terms: sensitivity, false positive, true negative, false negative.\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/specificity-medical-test/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C41395\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "sponsor", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: sponsor\nGlossary Definition: The group that is in charge of, or pays for, a research study.\nUse in Context: The study sponsor is often the drug or device company that makes and studies the product.\nMore Info: A sponsor in clinical research is a person or group that is responsible for the design, conduct, and oversight of a research study. \n\nThere can be different types of sponsors. A sponsor can be a drug or device company, governmental agency, academic institution, person, group, or private organization.\n\nA \"Funding Sponsor\" is a person or group that pays for the research study but does not conduct the study. \n\nA \"Regulatory Sponsor\" is a person or group that has to report to regulators (like the FDA) about the specific drug or device being tested in a study and may be conducting the study. \n\nA \"Sponsor Investigator\" is a person who designs, conducts, reports the study. The person is generally an academic researcher who is responsible to the regulatory agencies.\nOther Info to Think About When Joining a Study: The term \"sponsor\" may be in the consent form or mentioned when the study team discusses who is running the study. The sponsor is the person or group who is responsible for how the study is conducted.\n\nThe sponsor could be a drug company or a researcher. You can ask the study team who the sponsor is and if the sponsor of the study is the group that made the investigational product that will be used in the study. You may also ask if the investigators have any financial relationship with the sponsor outside of the study or have been paid by the sponsor for other services besides the study. In general, any financial relationships between researchers and companies should be described in the consent form and made clear to the study participants.\nRelated Terms: funder, sponsor investigator, pharmaceutical company\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/sponsor-3/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C70793\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "standard of care", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: standard of care\nGlossary Definition: The usual treatment given to patients for an illness.\nUse in Context: Some research studies compare the study treatment to the standard of care for a given condition.\nMore Info: Depending on the health issue, there could be many types of standard of care that are used by health care providers. \n \n For example, there are different medications used to treat high blood pressure.\nOther Info to Think About When Joining a Study: The term \"standard of care\" may come up in the consent form where it may explain that the study is comparing a new study intervention with the existing standard of care. \n\nIf you have any questions about the study treatment you are being given or the standard of care, you should feel free to ask the study team.\nRelated Terms: standard therapy, standard treatment, usual care\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/standard-of-care/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C94396\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "statistically significant", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: statistically significant\nGlossary Definition: Results that are very unlikely to have occurred by chance.\nUse in Context: Study results are analyzed to find out if they are statistically significant. \nMore Info: When a result is found to be statistically significant, it means that a study result probably did not happen by chance. It does not necessarily mean that the finding is clinically important.\n\nFor example - a study could show a new medicine lowers blood pressure (statistically significant) but the side effects are too great to make it a useful treatment (not clinically meaningful).\n\nSimilarly, a statistically significant result in a study may be different than a person's lived experience. For example, a study may show a statistically significant overall decrease in depression scores based on data collected from all participants in the study but an individual participant may still have feelings of depression. \nOther Info to Think About When Joining a Study: You might see the term \"statistically significant\" used in a research article when the authors discuss the results and statistics.\n\nThe results section may also provide more information about what it means for the data to be statistically significant.\n\nYou may also see this term in Plain Language Summaries of a study's results.\nRelated Terms: clinically meaningful\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/statistically-significant/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C61040\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "study design", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: study design\nGlossary Definition: The way a study is set up to answer the study question.\nUse in Context: It is very important for researchers to use a study design that will answer the study questions.\nMore Info: The study design determines how participants will be recruited and enrolled, whether participants will be randomized, what kinds of data will be collected, and how the data will be analyzed. \n \n There are many different types of study design.\nOther Info to Think About When Joining a Study: Researchers are careful about using the right study design to answer a specific question. You might learn about the study design from the study team or the consent form.\n\nYou may be able to find more information about the study you are thinking about joining at www.clinicaltrials.gov. There may be a section called \"How is the study designed?\"\n\n If there is anything you don't understand about the study design you should ask the study team. \nRelated Terms: design, single-blind study, double-blind study, randomization, observational study, clinical trial\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/study-design/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C15320\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "study feasibility", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: study feasibility\nGlossary Definition: How likely it is that a study can be completed.\nUse in Context: Research planning involves assessing study feasibility before starting to enroll participants.\nMore Info: In research, study feasibility means that: \n-the study procedures are all necessary and not overly burdensome, \n-the number of proposed participants should be possible to enroll in the locations chosen, and \n-the study will have enough participants to answer the study question.\n\nResearch teams should spend time looking at all the parts of the study to make sure they are \"doable.\"\n\nIf a study has low feasibility, it is less likely to generate enough data to answer the study questions.\n\nLow study feasibility is not a failure of participants. Low feasibility reflects a failure of the study planning process.\nOther Info to Think About When Joining a Study: Study feasibility is about checking whether a study can be done as proposed. This is not the same as a \"feasibilty study\" which is a study that is done to find out if an intervention is possible\n\nFeel free to ask questions about how the research team planned the study and how they are ensuring the study will be able to answer the planned research questions.\nRelated Terms: feasible, achievable, possible\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/study-feasibility/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C209473\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "study intervention", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: study intervention\nGlossary Definition: A treatment given to the participants in a study\nUse in Context: If a research study includes an intervention, it means participants will test something to see its effects. \nMore Info: A study intervention can be a treatment of a disease or condition or include ways to change behavior, attitudes, and maintain or improve health. For example, a study might test whether giving participants a step counter leads to weight loss.\nOther Info to Think About When Joining a Study: The study team or the consent form might mention the term \"study intervention.\" \n\nWhen you are learning about a clinical trial you should be given information about the study intervention which could be something you take (like a medicine) or do (like yoga) during the study to see if it has any effect.\n\nYou can always ask for more information about the study intervention the research is testing. You may also want to ask about the background of the study intervention and any prior research that was done that led to the researchers starting a new study. \nRelated Terms: study treatment, investigational product, investigational drug, investigational device\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/study-intervention/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C25218\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "study life cycle", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: study life cycle\nGlossary Definition: The steps of a research study from beginning to end.\nUse in Context: The study life cycle refers to all the steps that go into developing and running a research study.\nMore Info: The steps of the study life cycle include: developing the study protocol and procedures, participant recruitment, screening, and consent, ongoing study procedures, follow-up, end of study procedures, and study close-out.\nOther Info to Think About When Joining a Study: You might hear about the \"study life cycle\" when discussing the research process with a study team member. The term \"study life cycle\" is often used to describe the overall plan for the study. \n\nAs a participant, you are part of the study life cycle. If you join a study, your data are important for the study to be completed. Please feel free to ask the study team any questions you might have about the study. \nRelated Terms: clinical trial life cycle\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/study-life-cycle/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203929\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "study participant", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: study participant\nGlossary Definition: A person who joins a research study.\nUse in Context: A study participant volunteers to join research.\nMore Info: If you are a study participant in a research study, your data will help answer the research question.\nOther Info to Think About When Joining a Study: A person who joins a study is called a \"study participant.\" The consent form will describe the study, and what study participants will be asked to do.\n\nBefore you join a study you should understand what participating in the research will involve. Please ask any questions you have about being in the study.\nRelated Terms: participant, subject, research participant, research subject, study subject, healthy volunteer, data, clinical trial, observational study\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/study-participant/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142710\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "study population", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: study population\nGlossary Definition: All the participants in a study.\nUse in Context: A participant is a member of the study population.\nMore Info: The study population is described in the consent form and the protocol. \nOther Info to Think About When Joining a Study: You may hear the term \"study population\" from the study team or read it in the consent form. \n\nThere may be information about the number of individuals who are in the study population or what similarities the study population shares. The study population is also discussed in results and journal publications that describe what the study looked at. \n\nIf you have any questions about the study population, you should feel free to ask.\nRelated Terms: participant population, participant\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/study-population/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C70833\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "study statistician", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: study statistician\nGlossary Definition: A person who uses math to help design a study and interpret the data.\nUse in Context: The study statistician reviews and analyzes the data, and reports the results back to the study team.\nMore Info: Statisticians design studies to decrease bias and make the results as accurate as possible. \n\nBefore a study begins, a statistician can help the study team calculate how many participants should be enrolled so the research question can be answered.\n \nA study statistician can analyze study data and present the results using numbers, charts, and graphs. Study statisticians are trained to figure out whether a result happened by chance or not.\nOther Info to Think About When Joining a Study: You may hear that a study statistician is part of the research study and will work with the data collected during the study. \n\nIt is always fine to ask about who is working on the study and how your data are protected.\nRelated Terms: data, results, analysis\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/study-statistician/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142737\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "substudy", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: substudy\nGlossary Definition: A study with a smaller group of participants already enrolled in the main study.\nUse in Context: A substudy is a study to answer questions related to the main study.\nMore Info: A substudy asks a separate research question from the main study. It adds to the main study's objectives and uses all or a subset of participants or samples from the main study. \n\nA substudy is sometimes designed at the beginning of the main study. It is also possible that a substudy could happen later after some data have been analyzed.\nOther Info to Think About When Joining a Study: When you enroll in a study, there may be additional substudies you can choose to enroll in. For some substudies, you may need to go in for extra study visits or do some extra tests. The study team may want to collect more information from you to answer additional questions that the first study you enrolled in is not looking at. You will be consented for additional substudies.\n\nYou may want to ask if there are substudies in the study you join. Additionally, you can ask if you have to join any substudies and ask for more information about how the substudy is different from the first study you are enrolling in. It could also be helpful to ask if you have to do additional tests or go in for more study visits if you join a substudy. This could help you decide if you have the time to join.\nRelated Terms: basket trial, umbrella trial, cohort trial, master protocol\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/substudy/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C198230\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "superiority trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: superiority trial\nGlossary Definition: A study to test if a study treatment works better than another treatment for the same condition.\nUse in Context: One example of a superiority trial would be to test whether a new medicine is better for treating asthma than an existing one.\nMore Info: Superiority trials are done to find treatment options that work better than those that are already approved for a specific disease or condition.\nOther Info to Think About When Joining a Study: If you are thinking about joining a superiority trial, it will be a study that looks at whether one treatment works better than another. You should ask any questions you have about the treatments being tested before you consent.\nRelated Terms: superiority study, confirmatory trial, equivalence trial, control; non-inferiority trial\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/superiority-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C142722\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "synergistic effect", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: synergistic effect\nGlossary Definition: When two or more things combined have a greater effect than when their individual effects are added together.\nUse in Context: A synergistic effect means that the combined effects of two products is stronger than what was expected.\nMore Info: A combination of medications is synergistic if they work better together than if the individual component effects were added together.\n\nFor example, Drug A decreases cancer growth by 10% and Drug B by 20% when each are used alone. One would predict that used together, cancer growth might be decreased by 30% (additive). If Drug (A + B) used together decreases cancer growth by 35% or more, the effect is considered \"synergistic.\"\nOther Info to Think About When Joining a Study: The term \"synergistic\" is sometimes used to describe how two things that are used together actually have a greater effect than just one of them used alone. It's like the two things work in synergy with each other to have more of an effect.\n\nYou can ask the study team if you have any questions about the word \"synergistic\" is being used in study documents or conversations you are having.\nRelated Terms: additive effect\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/synergistic-effect/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203931\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "tolerability", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: tolerability\nGlossary Definition: How much a participant or group of participants can accept a study treatment's unwanted effects so they can keep taking it.\nUse in Context: Many drug studies look at the tolerability of the study treatment.\nMore Info: Tolerability is looked at to find out how easy it is for treatment is to be delivered. For example, researchers can learn whether a pill is too big to be swallowed. \n\nTolerability also tells us about the problems a treatment may cause, and how severe those problems are. If a person has to stop taking a study treatment because of related problems, then tolerability is low.\nOther Info to Think About When Joining a Study: Someone from the study team may ask you about the tolerability of the study treatment during follow-up visits or on questionnaires. \n\nYou may want to clarify what they mean by \"tolerability.\" For some people, nausea might be tolerable while for others its not, so you should let the study staff know what you are feeling while taking the study treatment. You could also ask the study staff what you should do if you are having trouble taking the study treatment, or wish to stop taking it.\nRelated Terms: safety, side effects, adverse effects\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/tolerability/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203932\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "treatment effect", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: treatment effect\nGlossary Definition: How much a study treatment changes a condition, symptom, or function.\nUse in Context: Some drug studies collect information from participants to measure the treatment effect.\nMore Info: The treatment effect shows how much the study intervention changes what the study is measuring when compared to not getting the study treatment or getting something different.\n\nFor example, a study might measure whether, and by how much, blood pressure is lowered when participants take a new medicine. \nOther Info to Think About When Joining a Study: For studies that are looking at what a study treatment does, researchers often measure the treatment effect which is connected to the main purpose of the study and the types of data being collected.\n\nYou should feel free to ask if you have any questions about how the treatment effect is being measured in the study.\nRelated Terms: study effect, intervention effect, efficacy\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/treatment-effect/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C209469\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "umbrella trial", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: umbrella trial\nGlossary Definition: A research study that tests and compares two or more study treatments for one disease or condition.\nUse in Context: In an umbrella trial, multiple study treatments are compared in a single disease or condition.\nMore Info: An umbrella trial is a type of randomized controlled trial (RCT). It is also a type of Master Protocol Study.\n\nAn umbrella trial uses a Master Protocol to compare different study treatments in the same way, using the same design, in a certain disease or condition.\n\nThe difference between a basket and an umbrella trial is that a basket trial uses one drug to test against multiple diseases while an umbrella trial studies different drugs in a single disease.\nOther Info to Think About When Joining a Study: \n\nYou may hear about umbrella trials when you are learning about different types of study designs.\n\nIf you are unsure about what it means for a research study to be an umbrella trial, you should ask a member of the study team to clarify any of your questions.\n\n\nRelated Terms: adaptive trial, master protocol, basket trial, platform trial\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/umbrella-trial/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C209470\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "validate", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: validate\nGlossary Definition: To confirm that a process or test works as planned, or results are true.\nUse in Context: In research, to validate something is to make sure that it works as expected.\nMore Info: Anything used to measure research data should be valid and precise. \n\nMedical tests and surveys are validated through a process to make sure that they are measure what they intend to measure. \n\nResults can also be validated, which means they go through a process to see if the findings are true.\nOther Info to Think About When Joining a Study: You may hear study teams talking about validating the data and information they collect. This could include checking measurements they take from you and comparing them to expected outcomes to see if the equipment is working correctly. \nRelated Terms: confirm, certify, substantiate, authenticate, replicate\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/validate/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C16237\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "voluntary participation", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: voluntary participation\nGlossary Definition: Choosing to participate in research without feeling pressured.\nUse in Context: Joining a research study is voluntary.\nMore Info: Research participation must be voluntary so no one feels pressured to join a study or that they must stay in a study. A participant can withdraw at any time.\nOther Info to Think About When Joining a Study: Before you join a study, the study team will want to be sure you know that participation is voluntary. The study team may tell you this verbally and it may also be in the consent form they give you to review. You should not feel forced into joining the study. \nRelated Terms: free will, freely chosen, independent choice, autonomy\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/voluntary-participation/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C203933\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "volunteer (to)", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: volunteer (to)\nGlossary Definition: To choose to join a study.\nUse in Context: A participant is someone who chooses to volunteer to join a research study.\nMore Info: Participants might be healthy volunteers or patients, but everyone is free to make their own decision about participation. Even if they volunteer, they are free to leave the study at any time.\nOther Info to Think About When Joining a Study: Your doctor may ask if you want to volunteer for a study during a visit. You may also see this when reviewing a consent form, letting you know you do not have to join this study if you do not want to.\n\nYou may want to ask your doctor about how to volunteer for a study. If you are considering volunteering for a study, you can ask about what the study procedures are and what will happen to participants in the study.\n\nYou should not feel pressured to join a research study.\nRelated Terms: agree, voluntary participation \nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/to-volunteer/\nCDISC/NCI URL: https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C203913\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "wash-out", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: wash-out\nGlossary Definition: A time before starting a study treatment when a person stops taking other medicines.\nUse in Context: A wash-out period removes certain current medications in the body so that they don't interfere with the study treatment.\nMore Info: In research, a wash-out is a time when medication is stopped so it can be cleared from a person's body before the study intervention is given. \n\nA wash-out period makes sure that the medication and the study intervention don't interact and increases the study's safety. it also helps to show that effects observed in a study are from the study medication and not previous, unrelated medications. \n\nNot every study has a wash-out period. When a study has a wash-out period it is a pre-set time that depends on the protocol and what medicines the person is taking.\nOther Info to Think About When Joining a Study: Whether a research study requires a wash-out will be described in the consent form and the study team will discuss this with you.\n\nIt will be important for you to ask if you will have to go through a wash-out period and how that might affect you if you have been taking medications regularly before starting the trial. It could be important to discuss this with your regular doctor to let them know you will be stopping your routine medications.\nRelated Terms: discontinue, remove\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/wash-out/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C42872\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "withdraw", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: withdraw\nGlossary Definition: To stop being a participant in a study.\nUse in Context: If a participant decides to withdraw from a study, they should discuss with the study team how to do so safely.\nMore Info: A participant can decide to withdraw from a study or an investigator can decide to withdraw the participant, usually for safety reasons. Reasons to withdraw from the study should be discussed.\nOther Info to Think About When Joining a Study: There may be information about how to withdraw from the study that you hear about when going through the consent process. \n\nIf you are thinking about stopping your participation in the study, ask the study team how to withdraw safely. You may also ask what may cause an investigator to withdraw you from the study. \n\nIf there are incentives for being part of the study, you may not get all of them if you leave the study early.\nRelated Terms: discontinue\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/withdraw/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C49634\nVersion: 2.0" }, { "source": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "sheet": "Clinical Research Glossary 0324", "term": "X-ray", "type": "Excel", "file": "2024-09-11-MRCT-Clinical-Research-Glossary-Excel-Download-alphabetized-1.xlsx", "text": "Glossary Term: X-ray\nGlossary Definition: A way of taking pictures of the inside of a person's body using X-ray radiation.\nUse in Context: An X-ray uses radiation to create images of bones, organs, and tissues. \nMore Info: An X-ray creates pictures of the inside of a person's body to view bone fractures and dislocations, certain tumors and other growths, pneumonias, fluid collections, and other problems.\nOther Info to Think About When Joining a Study: You may hear the term \"X-ray\" when the study team is talking about what happens in the esearch study. The study team could also say they are looking at your X-rays to get data for the study.\n\n If you do need an X-ray for the study, you can get more information about what kind of X-ray the study team will need and what part of the body they will scan. You can also find out if the X-ray results from the research will be put into your medical records for your regular doctor to see.\nRelated Terms: imaging study, CT scan, MRI\nOther Resources: \nTerm URL: https://mrctcenter.org/glossaryterm/x-ray/\nCDISC/NCI URL: https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C38101\nVersion: 2.0" }, { "source": "https://www.cdisc.org/", "type": "Website", "text": "Source URL: https://www.cdisc.org/. CDISC | Clear Data. Clear Impact. Skip to main content CDISC Roadmap See Where We Are Headed Read More Membership Join Our Member Community Learn More The Future is Connected: Standards and AI Powering Digital Transformation 2026 Europe Interchange Milan, ItalyMain Conference | 20 - 21 MayTraining and Workshops | 18, 19 & 22 May Learn More Celebrate Our 25th Anniversary With Us! Standards Access CDISC end-to-end Foundational and Therapeutic Area standards What's New Stay informed on the latest news, public reviews, and standards updates Education Expand your knowledge by attending a global public, private or online training Events Join us at one of our global events to discuss expertise, best practices and lessons learned in developing and implementing CDISC standards Membership Join over 450 organizations from around the world that support the CDISC vision and mission About Find out what we do and why we do it Working to amplify data's impactCDISC creates clarity in clinical research by bringing together a global community of experts to develop and advance data standards of the highest quality. Together, we enable the accessibility, interoperability, and reusability of data for more meaningful and efficient research that has greater impact on global health. Latest Updates Global Regulatory RequirementsCDISC Standards are required for regulatory submissions to FDA (U.S.) and PMDA (Japan).Learn More Use Cases for Clear DataLearn how organizations have applied CDISC Standards to bring clarity to data.Learn More Our Members" }, { "source": "https://www.scdm.org/", "type": "Website", "text": "Source URL: https://www.scdm.org/. Society for Clinical Data Management (SCDM) Skip to content 011 322 44 56Monday \u2013 Friday 10 AM \u2013 8 PMFacebook page opens in new windowX page opens in new windowInstagram page opens in new windowYouTube page opens in new window DiscoverSCDMOur Story Leadership Governance Get in Touch SCDM LiveAnnual Conference EMEA Conference India Conference China Conference Single Day Events SCDM KnowledgeCDM Competency Framework Thought Leadership & CDS elev8 at SCDM GCDMP\u00a9 Journal Podcasts SCDM CertificationCCDA CCDM CCDS SCDM CommunityMembership Volunteers SCDM Awards SCDM Bodies Partnerships Insights Careers Working together to create a healthier world. The Society for Clinical Data Management (SCDM) is an influential community that promotes industry best practices, education, and innovation. Our story Winter Issue 2025 Insights into Clinical Data Standards, automation of EHR to EDC, advances in NLP in the Oncology setting and an analysis of the Japan CDM core competencies. Explore the issue SCDM 2025 Annual Conference Festival of Opportunity Sept. 27-30, 2025 | Baltimore, Maryland. Register now WELCOME TO SCDMEmpowering the clinical data management profession, SCDM leads, educates, and influences. As the go-to resource for clinical data management professionals worldwide, we are at the forefront of the industry\u2019s transition to clinical data science. Join our vibrant community for peer-to-peer collaboration, knowledge-sharing, certification, and professional development. Our story CDM COMPETENCY FRAMEWORKEmpowering CDM professionals like never before. CDM Competency Framework Developed by industry experts, our game-changing CDM Competency Framework sets the gold standard for excellence, providing a roadmap to enhance your CDM skills and knowledge. Unlock your full potential as you develop your career with this essential guide, encompassing the skills, knowledge, and behaviors needed for mastery in the CDM profession. When coupled with SCDM\u2019s educational offering, our framework is set to equip you with the precise competencies required to stay ahead of the curve and advance in your career. SCDM ESSENTIALSFour work streams, one unique experience We have designed four distinct and complementary work streams to facilitate your journey through Clinical Data Management. Our comprehensive content ensures all you need is just a click away. The ultimate CDM knowledge bank, exclusively designed for you. GCDMP industry standards, JCSDM articles, SCDM White Papers, on-demand webinars, training courses, and much more. Join our global community and grow professionally. SCDM is a thriving community where members exchange experiences, collaborate together, gain new insights and expand their expertise. . Whether you are new to the industry or a seasoned professional, our inclusive community helps you get ahead. Unlock your potential with our industry-recognized professional certification Earn recognition for your expertise in Clinical Data Management with our tiered certific" }, { "source": "https://www.fda.gov/", "type": "Website", "text": "Source URL: https://www.fda.gov/. U.S. Food and Drug Administration Skip to main content Skip to FDA Search Skip to in this section menu Skip to footer links Topic Paragraphs See Complete List of FDA Reforms HHS Advances Women\u2019s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women\u2019s health. Read More Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood, and Biologics Animal and Veterinary Cosmetics Tobacco Products Report a Problem with an FDA Regulated Product Nov 19 FDA Pilots Faster Clarifications to Meeting Minutes Nov 14 FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury More Press Announcements Newsroom Meetings Testimony Speeches Nov 19 SHATA TRADERS INC RECALLS CHEF BRAND MILK PAN 24cm BECAUSE OF POSSIBLE HEALTH RISK Food & Beverages Nov 17 \u201cJeni\u2019s Splendid Ice Cream Voluntarily Recalls Passion Fruit Dreamsicle Ice Cream Bars Due to Undeclared Wheat and Soy.\u201d Food & Beverages Nov 14 Face Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk Food & Beverages More Recalls Market Withdrawals & Safety Alerts Subscribe to the Enforcement Report Mailing List Paragraph Header FDA Encourages Development of New, Reliable Alternatives to Animal Testing in Sunscreen FDA strongly encourages companies to continue to develop new, reliable ways to minimize animal testing. FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov. FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program ISTAND supports innovative, science-driven approaches that improve drug development and regulatory decision-making. View More FDA Voices Nov 17 Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use Drugs Nov 06 How to Prepare a Pre-Request for Designation (Pre-RFD) Biologics, Drugs, Medical Devices Oct 29 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Drugs FDA Guidance Search Jobs at FDA Inspections and Compliance MedWatch: Safety Alerts Science & Research FDA Organization Import Program Warning Letters Combination Products Criminal Investigations Disposal of Unused Medicines Emergency Preparedness Back to Top Feedback" }, { "source": "https://open.fda.gov/", "type": "Website", "text": "Source URL: https://open.fda.gov/. Open-source APIsLearn MoreView API Usage StatisticsThis site also offers an overview of the usage of API endpoints by the community.Download openFDA DataThe endpoints' data may be downloaded in zipped JSON format.View Community AppsopenFDA features an open user community for sharing open source code, examples, and ideas.Latest News & UpdatesVIEW ALL SEPTEMBER 13, 2025The dataset Cosmetic Adverse Events is now available.SEPTEMBER 5, 2025Complete Response Letters (CRL) issued in response to new drug applications (NDAs) and biologics license applications (BLAs) have been released. Currently, the database includes CRLs issued to sponsors as recently as 2025.MARCH 25, 2025The dataset Drug Shortages is now available." }, { "source": "https://www.ema.europa.eu/", "type": "Website", "text": "Source URL: https://www.ema.europa.eu/. European Medicines Agency (EMA) Skip to main content Homepage of the European Medicines Agency Public health threats Public health threatsSee overview Health threats Coronavirus disease (COVID-19) MpoxAntimicrobial resistanceMedicine shortages Previous NextEMA launches new podcast on European Antibiotic Awareness Day 2025Episode 1 of Inside EMA explores the fight against antimicrobial resistanceWatch podcastImproved scientific advice for medicines for public health threatsNew approach enables input on science and ethics at an early stageRead new guidanceHuman medicines committee meeting: November 2025 highlightsCHMP recommends ten new medicines for approval in the EURead highlightsKeeping medicines safeNew booklet on safety monitoring of medicines in the EURead about safety of medicines#ItTakesATeam \u2013 first campaign co-created with healthcare professional and patient organisationsCampaign highlights how different actors can help in case of a shortageRead about the campaign#HealthNotHype - EMA's first social media campaign with creatorsCampaign aims to raise awareness about safe and responsible use of GLP-1 receptor agonistsRead about campaign Find medicine Find information on centrally authorised medicines What's new Find all new and updated information published on our website in one place FAQs Find answers to the most frequent asked questions we receive Latest news First-in-class treatment to delay onset of type 1 diabetes Teizeild significantly delays onset of stage 3 diabetes and preserves functioning of cells producing insulin 20 November 2025 Improved scientific advice for medicines for public health threats including antimicrobial resistance New approach brings together clinical trial and ethics expertise to accelerate development of medicines for use ahead of or during emergencies 17 November 2025 First gene therapy to treat rare disease Wiskott-Aldrich syndrome Waskyra significantly reduces infections and bleeding episodes in people with life-threatening immunodeficiency 14 November 2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025 Ten new medicines recommended for approval; another four medicines recommended for extension of their therapeutic indications 14 November 2025 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 November 2025 Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting 7 November 2025 EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign Campaign highlights how different actors can help in case of a shortage 4 November 2025 SEE ALL NEWS Events 20 Nov 2025 Annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA) November 2025 OnlineEuropean Medicines Agency, Amsterdam, the Netherlands Start date: 20 November 2025, 09:00 (CET) End date: 20 November 2025, 16:45 (CET) 20 Nov 2025 Meeting of the Executive Steering Group on Shortages and Sa" }, { "source": "https://www.who.int/data/gho", "type": "Website", "text": "Source URL: https://www.who.int/data/gho. Global Health Observatory Skip to main content Global Health Observatory GHO Home Indicators Countries Data API GHO OData API Athena API Map Gallery Publications Data Search The Global Health ObservatoryExplore a world of health dataIndicators Countries Universal Health Coverage UHC enables everyone to access the services that address the most significant causes of disease and death, and ensures that the quality of those services is good enough to improve the health of the people who receive them. Health Emergencies Data about capacities required to rapidly detect, respond to and recover from any emergency health threat Health and Well-Being Data about mortality, diseases, substance and tobacco abuse/control and well-being Coronavirus disease (COVID-19) data Data on the Coronavirus disease (COVID-19) pandemic is currently available directly from these sources.Please note that the GHO APIs do not currently provide COVID-19 data. A data extract from the WHO Situation dashboard is available from UNOCHA's Humanitarian Data Exchange (HDX ) platform. This content is provided as set of regularly updated CSV files. Novel Coronavirus (COVID-19) Situation dashboard This interactive dashboard/map provides the latest global numbers and numbers by country of COVID-19 cases on a daily basis. Novel Coronavirus (COVID-19) Situation reports This report archive provides the latest available gobal data and an overview of the current situation. Search the theme you are interested in Air pollution Antimicrobial resistance (AMR) Assistive technology Child mortality Environment and health Food safety Global Dementia Observatory (GDO) Global Health Estimates: Life expectancy and leading causes of death and disability Global Information System on Alcohol and Health Global Patient Safety Observatory Health financing Health Inequality Monitor Health taxes Health workforce Hepatitis HIV Immunization coverage and vaccine-preventable diseases International Health Regulations (2005) monitoring framework Malaria Maternal and reproductive health Mental health Neglected tropical diseases Noncommunicable diseases Nutrition Oral Health Resources for Substance Use Disorders Road Safety SDG Target 3.8 | Achieve universal health coverage (UHC) Sexually Transmitted Infections Sustainable Development Goals Tobacco control Tuberculosis Vaccine-preventable communicable diseases Violence prevention Water, sanitation and hygiene (WASH) World Health Statistics Featured portals Maternal, Newborn, Child and Adolescent Health and Ageing In this portal you will find the most up to date global health data, including regional and country data organized separately in the areas of maternal, newborn, child and adolescent health. The data can be visualized on charts and maps which you can download. Global Strategy for Women's, Children's and Adolescents' Health (2016-2030) This data portal for the Every Woman Every Child (EWEC) Global Strategy is a collaborative product of the H6 agencies (UNAIDS, UNF" }, { "source": "https://opentrials.net/", "type": "Website", "text": "Source URL: https://opentrials.net/. OpenTrials \u2013 All the Data, on All the Trials, Linked This is an archived project from the Open Knowledge Foundation and it is no longer active. For any questions or to access the data please contact admin at okfn.org. OpenTrials is a collaboration between Open Knowledge International\u00c2 and Dr Ben Goldacre from the University of Oxford DataLab. It aims to locate, match, and share all publicly accessible data and documents, on all trials conducted, on all medicines and other treatments, globally. To find out more read this paper. Explore the public beta version of OpenTrials\u00c2 here. Intro video We are looking for: data partners, funding partners, community partners, individual partners & users. We are delighted to present the Open Trials advisory board. Statistics on reported #clinicaltrials data of the #FDA shows there is a lot of room for improvement! #transparency\u00e2\u0080\u00a6 https://t.co/x14oEnqQmA \"The best currently available evidence shows that about half of all #clinicaltrials don't report their results. Doc\u00e2\u0080\u00a6 https://t.co/kU63UY9YiX Follow @opentrials Discuss in our forum Subscribe to our mailing list First Name Last Name Email Address * Organisation" }, { "source": "https://www.rd-alliance.org/", "type": "Website", "text": "Source URL: https://www.rd-alliance.org/. Research Data Alliance (RDA) Global Community Priorities for Agentic AI in Research Nominations Open \u2013 2026 Sarah Jones Award Welcome to the RDA Knowledge Base The RDA Knowledge Base, developed via the RDA TIGER Project, officially launched on 6 October 2025. The RDA Knowledge Base consists of a number of specially developed tools, services, and usability improvements for RDA members. This suite of 4 services includes: \u2013 The RDA Graph: a comprehensive database of RDA-related data \u2013 RDA Discovery: a [\u2026] Call for Nominations for the RDA Technical Advisory Board (TAB) 2025 The RDA is seeking candidates for the annual TAB election, to be held in November-December 2025. TAB Terms are for three years. We encourage participation from RDA members at all stages of their careers. The Technical Advisory Board (TAB) is an essential and crucial governance board within the Research Data Alliance (RDA), providing the organization with [\u2026] Call for Sessions \u2013 RDA 26th Plenary Meeting (VP26), Fully Virtual The RDA 26th Plenary meeting (RDA VP26) will be held as a fully virtual event on the event platform Whova [hu:va] between 16-20 March 2026, under the theme \u2018Uniting scientists and researchers through global FAIR data\u2019. RDA Groups and RDA members are now invited to submit a session proposal indicating an interest in organising a meeting for VP26. Save the Date \u2013 RDA 27th Plenary Meeting (P27) The Research Data Alliance (RDA) is delighted to announce its 27th Plenary Meeting (P27), scheduled to take place from the 6-8 October 2026 in London, United Kingdom. View All RDA News Funders & Policy Makers Industry Infrastructures Libraries Research Performing Organisations Researchers & Scientists 100 Organisational & Affiliate Members 16214 Individual Members 116 Active Groups Become an RDA Member RDA Regions Africa and Europe The Americas Asia and Oceania RDA Europe RDA Europe is the European office of the RDA, supporting the regional communities, advocating for their unique and collective interests in the European data landscape, and facilitating the connection between national and global initiatives. Learn more about RDA Europe RDA Events Next Plenary RDA 26th Plenary Meeting Dates: 16 \u2013 20 March 2026Location: Online Join us for the RDA 26th Plenary Meeting as the global RDA community comes together to explore data continuity strategies that strengthen research resilience in times of change, crisis, and transformation. Read More Search All Plenaries Upcoming Plenary MeetingsSee All Plenaries Plenary RDA 27th Plenary Meeting (P27) Read More Plenary RDA 28th Plenary Meeting (VP28) The RDA 28th Plenary Meeting (RDA VP28) will be held virtually in the first part of\u2026 Read More Plenary RDA 29th Plenary Meeting [part of International Data Week 2027] Read More RDA Meetings & EventsView All Upcoming Events Event RDA Europe Train-the-Trainer Workshop on Research Data Management Are you looking to teach the fundamentals of Research Data Management (RDM) in your institution and" }, { "source": "https://pubmed.ncbi.nlm.nih.gov/", "type": "Website", "text": "Source URL: https://pubmed.ncbi.nlm.nih.gov/. PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Clipboard, Search History, and several other advanced features are temporarily unavailable. Skip to main page content The .gov means it\u2019s official. 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Learn About PubMed FAQs & User Guide Finding Full Text Find Advanced Search Clinical Queries Single Citation Matcher Download E-utilities API FTP Batch Citation Matcher Explore MeSH Database Journals Trending Articles PubMed records with recent increases in activity Global, regional, and national burden of headache disorders, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023. GBD 2023 Headache Collaborators. Lancet Neurol. 2025. PMID: 41240916 Cytosolic acetyl-coenzyme A is a signalling metabolite to control mitophagy. Zhang Y, et al. Nature. 2025. PMID: 41225001 Ms4a7 expression in cDC1s determines cross-presentation and antitumor immunity. Xie B, et al. Science. 2025. PMID: 41231994 Targeting formyl peptide receptor 1 reduces brain inflammation and neurodegeneration. Li Y, et al. Science. 2025. PMID: 41231983 Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China. Gao J, et al. Lancet. 2025. PMID: 41240964 See more trending articles PubMed Updates Feature updates and other PubMed highlights Recent Changes to References, Search Tools, Related Citations, and Sharing Features June 27, 2025 Key changes include improved rendering of reference lists, the addition of date stamps in search history downloads, streamlined sharing options, and other usability updates. FTP Improvements Available for Testing June 6, 2025 Starting with the annual baseline release in December 2025, the content of PubMed data distributed via FTP will be generated using the same technology as the PubMed website and E-utilities API; this update means the FTP data will match the PubMed website and API. Changes to Email Feature May 30, 2025 PubMed will soon reintroduce the ability to customize subject lines and body text when emailing search results or citations. With this update, the email feature will also require My NCBI login, and PubMed emails will only be sent to the email address associated with the My NCBI account. Phrase Searching in PubMed Tutorial Now Available March 3, 2025 With hands-on e" }, { "source": "https://www.ncbi.nlm.nih.gov/books/", "type": "Website", "text": "Source URL: https://www.ncbi.nlm.nih.gov/books/. Home - Books - NCBI The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation Bookshelf Search databaseAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRIdentical Protein GroupsMedGenMeSHNLM CatalogNucleotideOMIMPMCProteinProtein ClustersProtein Family ModelsPubChem BioAssayPubChem CompoundPubChem SubstancePubMedSNPSRAStructureTaxonomyToolKitToolKitAllToolKitBookghSearch termSearchBrowse TitlesAdvancedHelpDisclaimer Bookshelf Bookshelf provides free online access to books and documents in life science and healthcare. Search, read, and discover. Using BookshelfQuick Start GuideFAQTutorialsCopyright and PermissionsReadBrowse TitlesNew Releases PubReaderParticipateAuthors and PublishersHow to ApplyParticipation AgreementFile Submission Specifications New & Updated Everything you always wanted to know about European Union health policies but were afraid to ask: Fourth, revised edition [Internet]. Health Policy Series, No. 60.Greer SL, Rozenblum S, Fahy N, et al.Copenhagen (Denmark): European Observatory on Health Systems and Policies; 2024. Pediatric Quality Measures Program 3.0: An Evidence Map of Measures for Vision, Hearing, and Developmental Screening and Followup [Internet]. Technical Brief, No. 52.Kim JM, Han G, Wilson RF, et al.Rockville (MD): Agency for Healthcare Research and Quality (US); 2025 Apr. Screening for colorectal cancer in people with a familial risk: IQWiG Reports \u2013 Commission No. S23-01 [Internet]. Institute for Quality and Efficiency in Health Care (IQWiG).Cologne (Germany): Institute for Quality and Efficiency in Health Care (IQWiG); 2025 Sep 26. Pembrolizumab (breast cancer, triple-negative, neoadjuvant and adjuvant): Benefit assessment according to \u00a735a SGB V (expiry of the decision): IQWiG Reports \u2013 Commission No. A24-104 [Internet]. Institute for Quality and Efficiency in Health Care (IQWiG).Cologne (Germany): Institute for Quality and Efficiency in Health Care (IQWiG); 2024 Dec 20. How Do Patients Feel about Sharing and Linking Health Data for Research? [Internet]. O'Brien SM, O'Brien E, Lucas J, et al.Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2020 Jul. See more... Featured Titles Evaluation of an Enhanced Modified Kalman Filter Approach for Estimating Health Outcomes in Small Subpopulations [Internet]. Rossen LM, Talih M, Patel P, et al.Atlanta (GA): National Center for Health Statistics (NCHS); 2024 Sep. NCHS Data Briefs [Internet]. Hyattsville (MD): National Center for Health Statistics (US); 2024 Jul-. Planning, Development, Design, and Operation of the 2016 National Cu" }, { "source": "https://www.nih.gov/", "type": "Website", "text": "Source URL: https://www.nih.gov/. National Institutes of Health (NIH) | Skip to main content Official websites use .gov A .gov website belongs to an official government organization in the United States. Secure .gov websites use HTTPS A lock (LockA locked padlock) or https:// means you\u2019ve safely connected to the .gov website. Share sensitive information only on official, secure websites. Know Your Blood Pressure Numbers High blood pressure is a risk for heart disease. Knowing your numbers is the first step to controlling it. Learn more NIH Standardized Organoid Modeling (SOM) Center Image NIH will leverage the latest technologies to develop standardized organoid protocols, reducing the reliance on animal models. Autism Data Science Initiative Image Bringing together data resources to explore possible contributors to the causes of autism. NIH Loan Repayment Programs Image Researchers may be eligible for student loan repayment. Apply through November 20, 2025. NIH at a Glance Image The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation\u2019s medical research agency \u2014 making important discoveries that improve health and save lives. Take the Virtual Tour The NIH Director Funding for Research Labs at NIH Impact of NIH Research Jobs at NIH Featured Resources & Initiatives Image Explore NIH\u2019s groundbreaking initiatives and programs that are advancing biomedical research, accelerating scientific discovery, and improving health for all Americans. Clinical Trials Training at NIH RECOVER NIH HEAL Initiative Accelerating Medicines Partnership Medical Research Initiatives www.nih.gov An official website of the Department of Health and Human Services Looking for U.S. government information and services? Visit USA.gov Subir" }, { "source": "https://www.nih.gov/research-training/clinical-research-resources", "type": "Website", "text": "Source URL: https://www.nih.gov/research-training/clinical-research-resources. Clinical Research Resources | National Institutes of Health (NIH) Skip to main content Official websites use .gov A .gov website belongs to an official government organization in the United States. Secure .gov websites use HTTPS A lock (LockA locked padlock) or https:// means you\u2019ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 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Learn more about participating The Basics Answers to common questions about taking part in a clinical trial Finding a Clinical Trial How to search for clinical trials at NIH, around the nation, and worldwide Personal Stories Volunteers and researchers talk about their clinical research trial experiences For Parents and Children Resources for parents considering enrolling a child in a clinical study Help Get the Word Out! Image You can help raise public awareness of clinical trials with these promotional materials to connect individuals to ClinicalResearchTrials.nih.gov. Learn more Highlights Candidate malaria vaccine provides lasting protection in NIH-sponsored trials Immunotherapy approach shows potential in some people with metastatic solid tumors NIH-funded clinical trial links frequent anger to increased risk of heart disease View all highlights This page last reviewed on June 23, 2025 www.nih.gov An official website of the Department of Health and Human Services Looking for U.S. government information and services? Visit USA.gov Subir" }, { "source": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication", "type": "Website", "text": "Source URL: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication. Clinical data publication | European Medicines Agency (EMA) Skip to main content Clinical data publication As of October 2016, the European Medicines Agency (EMA) publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure. This is based on EMA's flagship policy on the publication of clinical data. Human Data on medicines By proactively publishing clinical data, EMA intends to help: avoid duplication of clinical trials, foster innovation and encourage development of new medicines; build public trust and confidence in EMA's scientific and decision-making processes; academics and researchers to re-assess clinical data. EMA has developed extensive guidance for industry to facilitate compliance with this policy. In this section Support for industry on clinical data publication Technical anonymisation group Background to clinical data publication policy Documents from advisory groups on clinical-trial data Resumption of clinical data publication for all medicines EMA has resumed clinical data publication for medicines with new active substances that received a CHMP opinion from September 2023 onwards, or were withdrawn before the opinion stage. EMA had temporarily suspended these activities for all except COVID-19 medicines in line with EMA's Final programming document 2023-2025 and its Management Board meeting of 14-15 December 2022. The clinical data packages for non-COVID-19 medicines published following the resumption are available in January 2024 via EMA's clinical data website. EMA now plans to expand activities (Step 2) related to Policy 0070 from April 2025. More information on the next steps in the resumption of these activities: Clinical Data Publication (Policy 0070) webinar - Step 2 | European Medicines Agency (EMA) (14/11/2024) Clinical Data Publication (Policy 0070) relaunch - EMA webinar (16/05/2023) Final programming document 2023-2025Reference Number: EMA/36710/2023 English (EN) (1.94 MB - PDF)First published: 31/01/2023 View How to access the clinical data Users need to visit EMA's clinical data website and log in with an EMA account. They can choose between an on-screen view only or a full download-and-print access. Terms of use apply - please see the clinical data website for details. What clinical data EMA publishes The Agency publishes the clinical data submitted by pharmaceutical companies to support their request for marketing authorisation, and which are assessed by the Committee for Human Medicinal Products (CHMP). Clinical data normally include: the clinical overview, providing a critical analysis of the clinical data in the submission package, including the conclusions and implications of the clinical data; the clinical summary, which provides a detailed factual summarisation of all the clinical information submitted; the study reports on the individual clinical studies; three appendices to the clinical study reports, namely the s" }, { "source": "https://report.nih.gov/", "type": "Website", "text": "Source URL: https://report.nih.gov/. Home | RePORT Skip Navigation Links RePORT RePORTER Search The RePORT Expenditures and Results (RePORTER) module allows users to search a repository of NIH-funded research projects and access publications and patents resulting from NIH funding. Enter just about anything in the RePORTER Quick Search box above (text, PI names, project numbers, fiscal year, agency) or launch the Advanced Search to precisely configure searches using separate search fields. RePORTER Home Advanced Search Matchmaker Enter abstracts or other scientific text and Matchmaker will return lists of similar projects from RePORTER or program officials associated with those projects. These matches are based on the terms and concepts used in the submitted text. Matchmaker summarizes the projects by the program official, institute or center, review panel, and activity code. Find a Match Awards by Location NIH Awards by Location - Explore year-by-year NIH funding by institution, state, congressional district, and more! See Report Categorical Spending Categorical Spending displays the annual support level for various research, condition, and disease categories based on grants, contracts, and other funding mechanisms used across the National Institutes of Health (NIH), as well as disease burden data. The NIH does not expressly budget by category. The annual estimates reflect amounts that change as a result of science, actual research projects funded, and the NIH budget. See Details NIH Data Book The NIH Data Book (NDB) provides basic summary statistics on extramural grants and contract awards, grant applications, the organizations that NIH supports, the trainees and fellows supported through NIH programs, and the national biomedical workforce. Launch Data Book RePORTER Matchmaker Awards by Location Categorical Spending NIH Data Book Welcome to Research Portfolio Online Reporting Tools (RePORT) In addition to carrying out its scientific mission, the NIH exemplifies and promotes the highest level of public accountability. To that end, the Research Portfolio Online Reporting Tools provides access to reports, data, and analyses of NIH research activities, including information on NIH expenditures and the results of NIH supported research. Spotlight Subscribe to the NIH RePORT ListServ to stay up to date on changes to these sites. RePORT Statistics Projects by Institute/Center Projects by State Trends in Major Fields of Study of NIH-Supported Ph.D. Recipients Research News News Highlights Implementation of New Initiatives and Policies Page Now Available - Mar 2025 How Can You Effectively Prepare NIH Research Project Grant Applications for Due Dates in 2025 and Beyond? - Mar 2025 Find NIH Funding Information More Quickly and Easily with RCDC\u2019s New Look and Feel - Mar 2025 Reviewer Guidance for the Simplified Review Framework - Mar 2025 Explore a Typical NIH Funding Opportunity - Mar 2025 NIH\u2026Turning Discovery Into Health\u00ae \u25b2 Back to Top" }, { "source": "https://www.who.int/observatories/global-observatory-on-health-research-and-development/resources/databases/databases-on-processes-for-r-d/clinical-trials", "type": "Website", "text": "Source URL: https://www.who.int/observatories/global-observatory-on-health-research-and-development/resources/databases/databases-on-processes-for-r-d/clinical-trials. Clinical trials Skip to main content Databases on processes for R&D Monitoring Benchmarking Indicators Analyses and syntheses Databases and resources Classifications and standards About Clinical trials databases WHO: International Clinical Trials Registry Platform (ICTRP) The WHO International Clinical Trials Registry Platform is \" a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others\". The platform has a searchable portal: International Clinical Trials Registry Platform (ICTRP) search portal clinicaltrials.govClinicalTrials.gov is a registry and results database of privately and publicly funded clinical studies conducted around the world. The resource is provided by the U.S. National Library of Medicine. Each study record includes a summary of the study protocol. Some study records include a summary of the results in a tabular format. Studies can be searched by status, condition or disease, country, or by other terms. The database is continually updated; it currently lists over 300,000 research studies located in all 50 states in the United States of America and over 200 other countries around the world.ISRCTN registryThe ISRCTN registry is a primary clinical trial registry. It is recognized by WHO and (International Committee of Medical Journal Editors) ICMJE and accepts all clinical research studies (whether proposed, ongoing or completed). Each study record includes a plain English summary as well as details of the study protocol. All study records can be searched using an advanced search function. Currently, the registry lists over 18,000 studies. EU Clinical Trials RegisterThe EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004. It also includes some clinical trials conducted outside the EU/EEA or some older trials that meet certain criteria. Study records indicate the trial protocol and provide results where available. Records can be searched using an advanced search function. Currently, the registry displays over 34,000 clinical trials.Pan African Clinical Trial Registry The PACTR is a regional register of clinical trials conducted in Africa. An open-access platform where clinical trials can be registered free of charge, providing an electronic database of planned trials and trials currently in progress. Databases and resources Databases with a focus on health R&D Databases on Inputs to R&D Databases on processes for R&D Databases on outputs for R&D Databases on cross-cutting information Methods with a focus on health R&D Priority setting methods Priority setting practices Priority setting evaluations Publications relating to health R&D Written or commissioned by the Observatory Relevant to the Observatory Wor" }, { "source": "https://www.cochranelibrary.com", "type": "Website", "text": "Source URL: https://www.cochranelibrary.com. Cochrane reviews | Cochrane Library Skip to Content Cookies Our site uses cookies to improve your experience. You can find out more about our use of cookies in About Cookies, including instructions on how to turn off cookies if you wish to do so. By continuing to browse this site you agree to us using cookies as described in About Cookies. I accept Colchicine for the secondary prevention of cardiovascular events Read review Semaglutide for obesity Read review Position statement on AI use in evidence synthesis Read editorial Independent, transparent, unbiased Read more Accessible evidence to support better decisions Read more Transforming global health and social care through evidence-based research Read more \u276e \u276f Scientific Strategy Climate change and sustainability Infectious diseases Maternal, newborn and child health Multiple chronic conditions View all \u25b6 Topics Blood and immune system conditions Cancer Cardiovascular conditions Cellular and gene therapies Complementary and alternative therapies Digestive system conditions Ear, nose and throat conditions Endocrinal, nutritional and metabolic disorders Eyes and vision Fertility, pregnancy and childbirth Gynaecological conditions Infections Injuries and wounds Lifestyle and wellbeing Liver conditions Mental health and behavioural conditions Musculoskeletal conditions Neurological conditions Public Health Radiotherapy Respiratory conditions Skin conditions Urological conditions Stay connected with us Set email alerts Search and Central sign up Follow us on Bluesky Latest news from Cochrane Call for proposals: AI tools to transform evidence synthesis 19 November 2025 Cochrane invites proposals from AI tool developers to participate in a pilot initiative aimed at transforming how we produce and share high-quality evidence syntheses. This is an exciting opportunity to collaborate with a globally trusted organization in health research and contribute to the future of systematic reviews. How can public health professionals overcome vaccine hesitation? 17 November 2025 Vaccination against human papillomavirus (HPV) is one of the most effective tools for preventing cervical cancer in women and other HPV-associated diseases in people of all genders. Yet many people worldwide remain reluctant to take the vaccine. Global evidence highlights social roots of HPV vaccine hesitancy 17 November 2025 Decisions about the HPV vaccine among adolescents and their families are influenced by a web of social, cultural and trust-related factors, beyond simple awareness or access View All Get involved Our evidence Our journal How to order Our products close Facebook X(Twitter) WhatsApp View more OK Cancel Close Review tools & navigation Cochrane Login Email Address Password Caps Lock is on. Remember Me Forgotten password? 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ClinicalTrials.gov PRS: Login Login Welcome to the ClinicalTrials.gov Protocol Registration and Results System (PRS). OMB NO: 0925-0586 EXPIRATION DATE: 03/31/2026 Burden Statement NOTICE The Modernized PRS is now the primary website for Protocol Registration and submission of Study Documents and Results. After logging in, you will be directed to the new website. The Classic PRS remains available for users who need to access features that have not yet been migrated to the Modernized PRS. Select the PRS version to open after logging in. Modernized PRS Classic PRS Organization: One-word organization name assigned by PRS (sent via email when account was created) Username: Password: Forgot password See How to Apply on ClinicalTrials.gov for information on how to apply for a PRS account. See PRS Guided Tutorials for assistance with entering registration and results information in the PRS. Send email to ClinicalTrials.gov PRS Administration. U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services | HHS Vulnerability Disclosure" }, { "source": "https://clinicalstudies.info.nih.gov/", "type": "Website", "text": "Source URL: https://clinicalstudies.info.nih.gov/. NIH Clinical Center: Search the Studies More Information About Clinical Center Clinical Trials and You Participate in a study Referring a Patient About Clinical Research Medical Information Disclaimer Emailed Inquires/Requests About Clinical Research \u00d7 Research participants are partners in discovery at the NIH Clinical Center, the largest research hospital in America. Clinical research is medical research involving people The Clinical Center provides hope through pioneering clinical research to improve human health. We rapidly translate scientific observations and laboratory discoveries into new ways to diagnose, treat and prevent disease. More than 500,000 people from around the world have participated in clinical research since the hospital opened in 1953. We do not charge patients for participation and treatment in clinical studies at NIH. In certain emergency circumstances, you may qualify for help with travel and other expenses Read more, to see if clinical studies are for you. Close Medical Information Disclaimer \u00d7 It is not the intention of NIH to provide specific medical advice, but rather to provide users with information to better understand their health and their diagnosed disorders. Specific medical advice will not be provided, and NIH urges you to consult with a qualified physician for diagnosis and for answers to your personal questions. Close Emailed Inquires/Requests \u00d7 Email sent to the National Institutes of Health Clinical Center may be forwarded to appropriate NIH or outside experts for response. 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Search Tip: Skip any items that are unknown or not applicable Keyword: Status: Select One Recruiting Enrolling by Invitation Recruitment has not started Active, not recruiting Clinical hold/Recruitment or Enrollment suspended Completed study/data analysis ongoing Study closed Age Group: Child (birth -17) Adult (18-65) Senior (66+) Sex: Select One Male Female Male & Female Institute/Center: All Institutes National Institutes of Health Clinical Center National Center for Complementary and Integrative Health National Cancer Institute National Eye Institute National Human Genome Research Institute National Heart, Lung and Blood Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Healt" }, { "source": "https://www.centerwatch.com/", "type": "Website", "text": "Source URL: https://www.centerwatch.com/. CenterWatch Homepage - Clinical Trial Listing Database & Insights | CenterWatch CenterWatch Homepage - Clinical Trial Listing Database & Insights | CenterWatch Skip to main content CenterWatch Research Hub Trusted thought leadership, transformative training, and essential clinical trial resources. Discover more than 40,000 clinical research opportunities that are updated daily. Browse Clinical Trials Artificial Intelligence WCG CenterWatch 2025 AI Benchmarking Report Reports Clinical Trial Operations and Efficiency WCG\u2019s 2025 Clinical Research Site Challenges Report Reports Patients, Participants, Caregivers and Advocates What Are Clinical Trials and How Do They Benefit Participants? Blog Posts Artificial Intelligence AI in Clinical Trials: Unlocking the Potential Podcasts Benchmark Reports See All Ethics, Compliance and Regulatory Guidance The 2025 Avoca State of the Industry Report: Understanding Adoption & Implementation of ICH E6(R3) Reports Ethics, Compliance and Regulatory Guidance ICH E6(R3) Guidance: Elevating Trials through Collaboration Articles Clinical Trial Operations and Efficiency WCG\u2019s 2025 CenterWatch Global Site Relationship Industry Report Reports In-Focus Topics Artificial Intelligence Data Science and Enabling Technology Ethics, Compliance, and Regulatory Guidance Patients, Participants, Caregivers, and Advocates Clinical Trial Operations and Efficiency Precision Medicine and Therapeutic Innovation Podcast series WCG Talks Trials Listen to the series Advancing Access: How SaaS is Transforming Clinical Trials Podcasts Advancing Imaging in Clinical Trials Using AI Podcasts Future-Ready Research: Optimizing Sites for Continued Success Podcasts Harnessing Generative AI in Clinical Research Podcasts Latest CenterWatch | Insights WCG CenterWatch 2025 AI Benchmarking Report Reports CenterWatch | Insights Beyond Binaries: Gender-Inclusive Language in Clinical Research Blog Posts CenterWatch | Insights WCG\u2019s 2025 Clinical Research Site Challenges Report Reports CenterWatch | Insights Advancing Access: How SaaS is Transforming Clinical Trials Podcasts CenterWatch | Insights Software-as-a-Service in Clinical Trials: Challenges and Opportunities Articles CenterWatch | Insights ICH E6(R3) Guidance: Elevating Trials through Collaboration Articles CenterWatch | Insights Advancing Imaging in Clinical Trials Using AI Podcasts CenterWatch | Insights Ensuring Representative US Enrollment in Oncology Clinical Trials: Navigating the Rising Tide of Regulatory Scrutiny Blog Posts CenterWatch | Insights Precision Matters: Elevating AI Excellence in MedTech and Pharma with WCG\u2019s Avoca Quality Consortium Articles CenterWatch | Insights Eyewash Stations & Gene Transfer Studies: NIH Guidelines Explained Blog Posts See All Insights Browse Insights By: Audience Biotech CROs Research Participants Research Sites & Institutions Research Sponsors Content Type Articles Blog Posts Podcasts Reports Research Resource Hub Videos Whitepapers" }, { "source": "https://www.antidote.me/", "type": "Website", "text": "Source URL: https://www.antidote.me/. Clinical Trial Patient Recruitment | Antidote Where patients meet research Sponsor? Accelerate your research with our precision recruitment services. Patient? Find the right clinical trials for you. Enter your condition below to start. There\u2019s a problem in medical research today. More than 80% of medical research is delayed due to a lack of participants. There\u2019s no good way for patients to find clinical trials that are right for them. The cost of these delays to patients and to researchers is too high. We\u2019re solving this problem in two ways: For sponsors We\u2019ve perfected precision recruitment to help sponsors fill clinical trials faster. For patients We\u2019ve made the process of finding trials easy with our smart Match search engine. Meet Eric Patients like Eric inspire us to continue our mission to accelerate medical research. Watch Eric's story Latest news Article Do You Need 'Patient' Recruitment? Article Bringing Patients Into View: Why Trial Recruitment ... Press AI TechPark: Antidote announced partnership with ... Blog Press Connect with Antidote We\u2019d love to hear from you! If you are a patient looking for clinical trial support, connect with us at patientsupport@antidote.me" }, { "source": "https://www.trialscope.com/", "type": "Website", "text": "Source URL: https://www.trialscope.com/. Regulatory & Compliance | Citeline Home / Our Products / Regulatory & Compliance Products Regulatory & Compliance Products & Services Regulatory & Compliance Citeline Regulatory & Compliance gives sponsors the information, tools and services they need to maintain clinical trial disclosure compliance, mitigate risk, increase transparency, and safeguard their brand reputation. Our Pink Sheet publication leads the industry in providing reliable insights and analysis of global regulatory policies and trends. TrialScope Disclose is the most widely trusted solution for clinical trial disclosure management. TrialScope Intelligence centralizes all the regulatory knowledge you need to ensure compliance in a user-friendly format, identifying and analyzing clinical trial disclosure requirements globally. Our Disclosure Services include protocol registration, results disclosure, plain language summaries and redaction. Understand more about how our solutions can help you gain a competitive advantage Our Regulatory & Compliance Products Pink Sheet The leader in pharmaceutical news and regulatory trend analysis Regulatory & Medical Writing Services Essential for regulatory approval and compliance, requiring adaptation to evolving guidelines, management of complex scientific data, and ensuring accuracy to avoid delays or rejections. TrialScope Disclose Manage the complexity of clinical trial disclosure and the risk of non-compliance by automating data entry and reporting to registries TrialScope Disclosure Services Hands-on clinical trial disclosure services, from regulatory writing to registration to results TrialScope Intelligence A centralized, interactive repository of the critical regulatory knowledge needed for global clinical trial disclosure compliance Trial Summaries This user-friendly portal aggregates clinical trial results summaries across sponsors Understand more about how our solutions can help you gain a competitive advantage Other solutions you may be interested in Study Management & Reporting Regulatory Planning & Strategy Consulting & Analytics Feasibility & Site Selection Speak to a specialist A specialist is ready to speak to you regarding your interests and find the solutions that are right for you. 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Don't have an account? Sign-up as a volunteer or researcher Make a positive impact by volunteering for research Join Now! What is ResearchMatch? ResearchMatch is a nonprofit program funded by the National Institutes of Health (NIH). It helps to connect people interested in research studies with researchers from top medical centers across the U.S. Get connected to research on many different health conditions - through ResearchMatch. Learn More How does ResearchMatch work? Volunteers 122,375 Researchers 18,011 Studies 1,412 Institutions 261 Publications 932 Our ResearchMatch Network ResearchMatch is a free and secure tool that researchers use to invite Volunteers to take part in their health research studies. See our network of 261 research institutions. Learn More Join as a Researcher ResearchMatch is making an impact. Here\u2019s what people are saying. Our Volunteers Read more We need proven treatments for ourselves, and our families and not only rely on research conducted on other demographic groups, however, this can only happen if we ourselves are volunteers in clinical research. Read less \u2014 Libia Duran \u2014 Read more I joined ResearchMatch as a volunteer because I believe that I need to contribute in the progress of medical knowledge which can help me, my family, my neighbor, and my community today and in the future. Read less \u2014 Martha Silva \u2014 Read more I was able to help contribute to health research by participating in research studies. It has been a great experience so far! Read less \u2014 Xiaoxin Kuang \u2014 Our Collaborators ResearchMatch proudly collaborates with 261 participating institutions and 68 community organizations to bring important research studies, health information, and resources to you. Previous Next See Organizations See Institutions Search for a health condition: Enter a health condition in the box below to learn more. Search Search Results Close External Site You are about to leave ResearchMatch Stay on ResearchMatch Leave ResearchMatch" }, { "source": "https://www.ncbi.nlm.nih.gov/pmc/", "type": "Website", "text": "Source URL: https://www.ncbi.nlm.nih.gov/pmc/. PMC Home Skip to main content Official websites use .gov A .gov website belongs to an official government organization in the United States. Secure .gov websites use HTTPS A lock ( Lock Locked padlock icon ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites. PubMed Central (PMC) Home Page Search PMC Full-Text Archive Search in PMC Journal List PubMed Central\u00ae (PMC) is a free full-text archive of biomedical and life sciences journal literature at the U.S. National Institutes of Health's National Library of Medicine (NIH/NLM) About PMC Discover a digital archive of scholarly articles, spanning centuries of scientific research. User Guide Learn how to find and read articles of interest to you. Collections Browse the PMC Journal List or learn about some of PMC's unique collections. For Authors Navigate the PMC submission methods to comply with a funder mandate, expand access, and ensure preservation. For Publishers Learn about deposit options for journals and publishers and the PMC selection process. For Developers Find tools for bulk download, text mining, and other machine analysis. 11.5 million articles are archived in PMC. Content provided in part by: 3011 Full Participation Journals Journals deposit the complete contents of each issue or volume. 257 NIH Portfolio Journals Journals deposit all NIH-funded articles as defined by the NIH Public Access Policy. 45 Selective Deposit Programs Publisher deposits a subset of articles from a collection of journals. New in PMC Sept. 9, 2025 Updated Full-Text Search Now Available As previously announced, NCBI has updated the PubMed Central (PMC) full-text search functionality and user experience. To prep\u2026 Sept. 2, 2025 PMC OAI-PMH API Updated The PMC OAI-PMH API, a tool that allows users to retrieve metadata in Dublin Core or JATS XML for all articles in PMC, has bee\u2026 highlights Updated Full-Text Search Now Available NCBI has updated the PubMed Central (PMC) full-text search functionality and user experience. Read More" } ]