id stringlengths 36 36 | text stringlengths 95 399 | source stringclasses 1
value |
|---|---|---|
f6b94a2c-6285-49b8-b740-f2830a602237 | • Recovered and the patient returned to baseline status
• Recovered with permanent sequelae
• Symptoms persist
10.2.3 Time Period for Adverse Events
Adverse events will be recorded from the time of randomization and will continue through
28 days after randomization, hospital discharge, or death, whichever occurs earlie... | protocol.txt |
bfc71952-593d-4fc3-8aca-4a15452dadb8 | events will not be recorded for subjects who are in the observational cohorts, since there is no
study intervention nor randomization event.
10.2.4 Data Collection Procedures for Adverse Events
Subjects who have been randomized to study drug will undergo daily screening for adverse
events from the first day of study dr... | protocol.txt |
f9e4412b-a281-4e51-9337-370eff5a782f | discharge, or death, whichever happens first. This screening will include review of all vital
signs, all clinically-ordered laboratory data and imaging studies, physical exam findings (as
documented in the medical record by the clinical team), and clinical progress and procedure
notes since the time of the prior day’s ... | protocol.txt |
3bd95b6e-4266-4a77-b390-e84e5081a9f4 | that documents clinical, laboratory, and radiographic abnormalities that are present prior to the
start of study drug. Any medical condition or laboratory abnormality that is present prior to
randomization, which remains unchanged or improves (unless the clinician feels it is clinically
relevant), will not be recorded ... | protocol.txt |
6f52e725-ab25-4933-8018-48600ed4c025 | ing of a medical condition that was present at the time of randomization will be considered a
new adverse event and reported.
After patient randomization all adverse events (including serious adverse events) will be
recorded according to relatedness, severity, and expectedness, as well as their duration and | protocol.txt |
d06e1ab7-d5e9-4570-9e5f-ea63c224dd37 | any treatment prescribed. Abnormal laboratory values that are clinically significant will be
recorded as adverse events and the site investigator will assess the relationship to the study and
expectedness.
Adverse events will be coded using the MedDRA coding vocabulary. Coding will be done
centrally at the Data Coordin... | protocol.txt |
762aabd7-7a95-4053-9029-629d20f56e5b | Common Terminology for Criteria for Adverse Events (CTCAE) scoring system.
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10.2.5 Unanticipated Problems (UP)
Unanticipated problems (UP) are d... | protocol.txt |
fd6561f9-e268-486b-8937-b0c6820da96d | pected, related or possibly related to participation in the study, and suggest that the research
places subjects at a greater risk of harm than was previously known or recognized. The site
investigator will report unanticipated problems to the Data Coordinating Center within 24 hours
of becoming aware of the event. A d... | protocol.txt |
2c5e9c16-ecad-4121-ad18-8ca14b85b900 | Data Coordinating Center within 3 working days of the event. After receipt of the complete
report, the Data Coordinating Center will report these unanticipated problems to the NICHD
Project Officer in an expedited manner (as close to 24 hours as possible). The medical monitor
(Section 10.2.6) for the study will assess ... | protocol.txt |
02693a57-9fc9-4d4f-aab9-5a471bed36c0 | acting as the single IRB for the study, may be required. In addition, dependent on the nature of
the unanticipated problem, all participating institutions may require notification. In the event
that the medical monitor believes that such an event warrants emergent suspension of enrollment
in the trial, and NICHD staff ... | protocol.txt |
60592feb-39b2-48aa-8993-38902117c328 | will notify the study investigators (Drs. Hall, Zuppa and Mourani) and all site investigators to
cease enrollment in the trial. Resumption of enrollment will not occur without consent of the
NICHD staff after discussion with the DSMB.
10.2.6 Monitoring Serious Adverse Events
A qualified physician will be designated to ... | protocol.txt |
3eabc37d-7918-4960-9937-516eba126c6c | study. Site investigators and/or research coordinators will report serious adverse events to the
Data Coordinating Center within 24 hours of becoming aware of the event. A detailed completed
report will be required to be sent to the Data Coordinating Center within 3 working days of
the event, and the medical monitor wi... | protocol.txt |
b23602ac-bea6-4124-9e33-2864a2e4239c | For each of these serious adverse events, the site investigator will provide sufficient medical
history and clinical details for a safety assessment to be made with regard to continuation of the
trial. The medical monitor will sign off on each SAE report after review. All SAE reports will
be retained at the Data Coordi... | protocol.txt |
19e1994d-40c2-4f95-9290-ac31d5a1135e | DSMB members and NICHD staff. The SAE reporting process may be incorporated into the
Electronic Data Capture (EDC) System in use for the study.
In the unlikely event that the medical monitor believes an unexpected and study-related SAE
warrants emergent cessation of enrollment in the trial, NICHD staff and the DSMB cha... | protocol.txt |
9e34edf5-dff3-478c-b07d-1c532b7d016e | will be immediately consulted. If these individuals concur with the judgment of the medical
monitor, or if the NICHD staff and the DSMB chairperson cannot be reached expeditiously, the
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796fb092-cb7f-4f35-9a98-22f421ba53de | Data Coordinating Center will notify the study investigators (Drs. Hall, Zuppa and Mourani) and
all site investigators to cease enrollment in the trial. Resumption of enrollment will not occur
without consent of the NICHD staff after discussion with the DSMB. The IRB in Utah will be
notified, and each site investigator... | protocol.txt |
b1131a35-e373-46e9-9381-cb5de6f71897 | program of the trial suspension.
Criteria for halting enrollment in the TRIPS trial pending a formal safety review include:
• The death of a randomized subject in whom the cause of death is judged to be probably or
definitely related to the study drug.
• The occurrence, in any subject, of a life-threatening SAE whose c... | protocol.txt |
606b9d0d-6053-4865-b3f8-47470220eb37 | • Two (2) occurrences of Grade 3 or higher toxicities that are judged to be probably or
definitely related to the study drug.
• Two (2) occurrences of a clinically significant Grade 3 or higher laboratory abnormality
that are judged to be probably or definitely related to study drug.
After notification of the NICHD Pro... | protocol.txt |
9b55c060-7ece-4427-9689-7e01954c034d | son, of serious, unexpected, and study-related adverse events or unanticipated problems (UP),
decisions will be made whether to continue the study without change, and whether to convene
the entire DSMB for an emergent meeting. If a decision is made to suspend enrollment in the
trial, this will be reported to the study ... | protocol.txt |
39398f19-d813-4b11-8306-8b5fbe3d7362 | clinical investigators, who will be instructed to report this to their local IRB.
The DSMB will review all adverse events (not necessarily serious, unexpected, and study-
related) during scheduled DSMB meetings which will occur at least twice annually. The Data
Coordinating Center will prepare a Summary Report of Adver... | protocol.txt |
decb55c7-dbd8-49b8-97c5-c2833a928338 | DRA coding system, for the DSMB meetings, including the proportion of subjects experiencing
treatment-emergent adverse events. The occurrence of any adverse event will be considered
as a dichotomous outcome and compared between arms using a chi-squared test. Cumulative
data on treatment-emergent adverse events will be ... | protocol.txt |
dcddf2cf-fc2a-496f-a7dd-102b725a867f | manuscript at the conclusion of the trial.
10.2.7 Individual Subject Stopping Rules for TRIPS Trial
The administration of study drug will be discontinued in individual subjects if they develop:
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0fe20597-a704-4d14-9b72-f90050109c5c | • A new, unexpected, serious adverse event that is determined to be probably related to
study drug.
• A new reduction in absolute neutrophil count to <1,000 cells/mm3 on two consecutive
days while receiving study drug.
10.2.8 Follow-up of Serious, Unexpected and Related Adverse Events
All serious, unexpected and relate... | protocol.txt |
97094798-e3bc-4adf-ba8d-1228b53ee52f | patient’s termination from the study or discharge from the hospital, will be followed by the
site investigators until the events are resolved, subject is lost to follow-up, the adverse event is
otherwise explained or has stabilized, and continuity of care with a responsible clinical team
has been assured.
10.2.9 Report... | protocol.txt |
0155bf60-809f-44d4-9684-afa5ba7eda1d | Serious, unexpected and related adverse events will be reported to the FDA in an expedited
manner consistent with FDA requirements. The Data Coordinating Center will prepare the
report for submission by the principal investigator, Dr. Hall, who holds the IND.
11 Study Training
A formal training program for investigator... | protocol.txt |
01db6da4-68e3-443a-b7f1-9402867daf0c | of enrollment. The training program will cover regulatory topics and Good Clinical Practice.
The training will also provide in depth explanations regarding study procedures, clinical care,
adverse event reporting, data entry procedures, quality assurance, site monitoring, and the
informed consent process. No site will ... | protocol.txt |
185d5f47-7c10-4165-96b8-21ab583d3133 | fulfilled by the site investigators and research staff.
A manual of operations will be provided to each investigator prior to the start of enrollment.
The manual will detail specific information about the study procedures, regulatory informa-
tion, safety reporting, and other necessary information. Updates and revision... | protocol.txt |
cdbf002f-9845-4c18-acd9-e08737ddaf97 | will be made available electronically. The Data Coordinating Center, in collaboration with the
study investigators (Drs. Hall, Zuppa and Mourani), will be the main contact for study questions.
Each participating clinical site that has not previously participated in CPCCRN studies
using the TNFαresponse assay will under... | protocol.txt |
43b2cbbf-efeb-42e5-bd02-7bce8ceb69ba | familiarity with clinical and laboratory procedures required for immune phenotyping. In the
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event that this is not possible (e.g., due to COVID... | protocol.txt |
9d050378-3e1a-4ac2-ab0f-1dd4ea1a4f57 | virtually, including video documentation of pharmacy and laboratory capabilities.
12 Regulatory Considerations
12.1 Food and Drug Administration
This trial is being conducted under an Investigational New Drug application approved by the
Food and Drug Administration. The clinical investigator at each participating site ... | protocol.txt |
73bdf767-2c59-4c82-b513-804a582e38b6 | 12.2 Health Insurance Portability and Accountability Act
Data elements collected include the date of birth and date of admission. Prior to statistical
analyses, dates will be used to calculate patient age at the time of the study events.
Data elements for race, ethnicity, and gender are also being collected. These demo... | protocol.txt |
2cac3de6-5723-4669-9402-f411ac97d596 | data are required for Federal reporting purposes to delineate subject accrual by race, ethnicity,
and gender.
For purposes of the DCC handling potential protected health information (PHI) and pro-
ducing the de–identified research data sets that will be used for analyses, all study sites have
been offered a Business As... | protocol.txt |
e12a6877-3a90-4088-9ffe-063c707bc66c | Business Associate Agreements are maintained at the DCC.
12.3 Inclusion of Women and Minorities
There will be no exclusion of patients based on gender, race, or ethnicity.
12.4 Clinical Trial Registration Requirements
The GRACE-2 and TRIPS trials will be separately registered at https://clinicaltrials.
gov in accordanc... | protocol.txt |
8a05e0a3-7e33-427e-a1bd-2bb4b33986ad | For federally funded studies subject to the Common Rule, records relating to the research
conducted shall be retained for at least 3 years after completion of the research. Completion of
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68531e6a-c296-4d7f-969b-020e822220cd | the research for this protocol should be anticipated to include planned primary and secondary
analyses, as well as subsequent derivative analyses. Completion of the research also entails
completion of all publications relating to the research. All records shall be accessible for
inspection and copying by authorized rep... | protocol.txt |
23987f41-aa73-48bc-b3db-91abe40125f8 | times and in a reasonable manner [45 CFR §46.115(b)].
12.6 Public Use Data Set
After subject enrollment and follow up have been completed, the DCC will prepare a final study
database for analysis. A releasable database will be produced and completely de-identified in
accordance with the definitions provided in the Heal... | protocol.txt |
e4264574-5593-454e-8ff4-b462a6b2e31c | Act (HIPAA). Namely, all identifiers specified in HIPAA will be recoded in a manner that will
make it impossible to deduce or impute the specific identity of any patient. The database will
not contain any institutional identifiers.
The DCC will also prepare a data dictionary that provides a concise definition of every ... | protocol.txt |
b3142ee8-5407-4cc0-b27a-64bd4f28f6b4 | element included in the database. If specific data elements have idiosyncrasies that might affect
interpretation or analysis, this will be discussed in the dictionary document. In accordance with
policies determined by the investigators and funding sponsors, the releasable database will be
provided to users in electron... | protocol.txt |
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