Upload glossary_clean.txt

persistent/glossary_clean.txt

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+AABB
+AADA
+AAMC
+AAPS
+AAS
+abbreviation
+ABPI
+absorption
+accelerated approval
+ACCP
+accrual
+ACDM
+ACE
+ACIL
+ACPU
+ACRA
+acronym
+ACRP
+ACT
+ACTG
+action letter
+activation (EDC)
+active ingredient
+active ingredient dose
+active substance
+ACTU
+ADaM
+adaptive design
+additive effect
+ADE
+adequate and well-controlled studies
+adherence
+adjuvant therapy
+ADME
+administrable dosage form
+administration (substance)
+administrative claims data
+admission criteria
+ADR
+adverse drug reaction (ADR)
+adverse event
+adverse event of special interest
+adverse reaction
+AE
+AEGIS
+AERS
+AFMR
+AHA
+AHCPR
+AHIC
+AI
+AI prompt
+AICRC
+AIDS
+ALCOA
+ALCOA+
+ALCOA++
+alert
+algorithm
+alpha error
+AMA
+AMC
+amendment
+American National Standards Institute (ANSI)
+AmFAR
+AMG
+AMP
+AMWA
+analysis
+analysis dataset
+analysis set
+analysis variables
+analyze
+anchor
+ANDA
+anonymization
+anonymize
+ANOVA
+ANSI
+antagonistic effect
+antibody
+anticipated adverse event
+antigen
+AOAC
+APB
+APhA
+API
+APPI
+applet
+applicable regulatory requirement(s)
+approvable letter
+approval (in relation to Institutional Review Boards)
+approval letter
+ARCS
+arm
+ARO
+artificial intelligence (AI)
+ASAP
+ASCII
+ASCPT
+ASP
+ASQ
+assent
+assent form
+assessment
+ATC
+attributable
+attribute (n)
+AUC
+audit
+audit certificate
+audit report
+audit trail
+authorised auxiliary medicinal product
+authorised investigational medicinal product
+authorization
+autoimmunity
+auxiliary medicinal product
+AxMP
+back translation (natural language)
+background material
+background treatment
+balanced study
+bandwidth
+BARQA
+baseline assessment
+baseline characteristics
+baseline imbalance
+basket trial
+basket trial design
+Bayesian approaches
+Bayesian statistics
+BCE
+BDPA
+benefit summary
+benefits of a research study
+BEST
+beta error
+BEUC
+BfArM
+BGA
+BGVV
+bias
+BID
+BIO
+bioanalytical assays
+bioavailability
+biobanking
+bioequivalence
+biological product
+Biologics licensing application (BLA)
+biomarker
+biometric signature
+biorepository
+biosimilar
+biospecimen
+biostatistics
+BIRA
+birth control
+blind review
+blinded (masked) medications
+blinded study
+blinding
+blood draw
+branch
+BrAP
+BRIDG
+browser
+BSA
+C3C
+CA
+caBIG
+cache
+caCORE
+caDSR
+carry-over effect
+CAS
+case history
+case report form (CRF)
+case report tabulations (CRT)
+case-control study
+categorical data
+causal effect
+causal inference
+causality assessment
+CBER
+CBIIT
+CCPPRB
+CCRA
+CCRC
+CCRP
+CCSI
+CDA
+CDASH
+CDC
+CDE
+CDER
+CDISC
+CDISC Library
+CDISC standards
+CDM
+CDMS
+CDRH
+cell therapy
+CEN
+certified copy
+certified IRB professional (CIP)
+CEU
+CF
+CFR
+cGMP
+challenge agent
+CHI
+CHR
+CIC
+CIOMS
+CIP
+CIS
+class
+clean database
+clean file
+CLIA
+client
+clinical benefit
+clinical clarification
+clinical data
+clinical development plan
+clinical document
+clinical document architecture
+clinical efficacy
+clinical encounter
+clinical hold (of a clinical trial)
+clinical investigation
+clinical outcome assessment (COA)
+clinical pharmacology
+clinical research
+clinical research and development
+clinical research associate (CRA)
+Clinical Research Coordinator (CRC)
+clinical research subject
+clinical significance
+clinical study
+clinical study data element
+clinical study report
+clinical trial
+clinical trial authorization
+clinical trial data
+clinical trial exemption (CTX)
+clinical trial information
+clinical trial materials
+clinical trial registry
+clinical trial results registry
+clinician
+clinician-reported outcome (ClinRO)
+cluster randomized trial
+Cmax
+CMC
+CME
+CMS
+CNS
+co-packaged product
+COA
+codelist
+coding
+cognitive debriefing
+cohort
+cohort study
+combination product
+commercially confidential information (CCI)
+common data element
+common data model (CDM)
+Common Technical Document
+Comparative Effectiveness Research (CER)
+comparative study
+comparator
+compendial name
+compensation
+Competent Authority (CA)
+compliance
+computable phenotype
+computer application
+Computerized Tomography (CT) scan
+concept
+concept of interest
+concerned member state (CMS)
+concomitant medication
+conduct
+confidence interval
+confidentiality
+confirmatory trial
+conformity assessment
+confounding
+consent form
+CONSORT
+construct validation (COA)
+content validation (COA)
+context of use
+contingent subject trial contact
+continuity of coverage
+contract
+Contract Research Organization (CRO)
+contraindicated
+control
+control group
+controlled study
+controlled vocabulary
+coordinating committee
+coordinating investigator
+correlation
+COSTART
+COU
+covariate (prognostic)
+COVID-19
+CPHS
+CPMP
+CPSC
+CR
+CRA
+CRADA
+CRB
+CRC
+CRF
+CRF data
+criterion validation (COA)
+CRIX
+cross-sectional study
+crossover trial
+CRT
+CSDD
+CSF
+CSM
+CSO
+CSR
+CT
+CTA
+CTC
+CTCAE
+CTD
+CTEP
+CTM
+CTX
+CUI
+curriculum vitae (CV)
+CVM
+cybersecurity
+data
+data acquisition
+data capture
+data clarification
+data coding
+data collection
+data controller
+data curation
+data element
+data entry
+data harmonization
+data imputation
+data integrity
+data interchange
+data item
+data lake
+data listing
+data management
+data minimization
+data model
+data monitoring
+data origin
+data processor
+data quality
+data security
+data sharing
+data standards
+data storage
+data subject
+data transformation
+data type
+data validation
+data warehouse
+database
+database lock
+dataset
+date of first enrollment
+DAWN
+DCGI
+decision rule
+Declaration of Helsinki
+deep learning
+Define-XML
+demographic data
+dependent variable
+derived variable
+design configuration
+development plan
+DHTML
+diagnose
+diagnostic device
+direct access
+discontinuation
+disease
+disease progression
+dissemination
+distributed data network
+DLT
+DNA
+document (HL7)
+documentation
+domain
+dosage
+dosage form
+dosage regimen
+dose
+dose escalation
+double-blind study
+double-dummy
+dropout
+drug
+drug development process
+drug distribution
+drug holiday
+drug interaction
+drug product
+drug therapy
+DSMB
+DSUR
+DTC
+dynamic HTML
+e-consent
+E3C
+Early Phase I
+early termination of trial
+EC
+EC50
+eCertified copy
+ECG
+ECJ
+eClinical trial
+eCOA
+ECOG
+eConsent form
+eCRF
+ECRIN
+eCRT
+eCTD
+EDC
+EDI
+edit check
+eDMS
+EDR
+effect size
+effectiveness
+efficacy
+EFGCP
+EFPIA
+EFTA
+EHR
+EIR
+electronic data transfer
+electronic health record (EHR)
+electronic personal health record (ePHR)
+electronic record
+electronic signature
+eligibility criteria
+EMA
+Emergency Use Authorization (EUA)
+EMR
+endemic disease
+endpoint
+enroll
+enrolled
+enrollment
+epoch
+ePRO
+equivalence
+equivalent effect
+ER
+ERSR
+eRX
+eSource
+essential documents
+estimand
+ethics committee
+ethnicity
+EU
+EU CTR
+EudraCT
+evaluate
+exclusion criteria
+expanded access
+experimental unit
+exploratory IND study
+exposure
+extraction transformation load (ETL)
+FAERS
+FAQ
+FD&C Act
+FDA
+FDAMA
+feels
+field
+final report
+finding
+first subject in - date
+first subject screened - date
+first subject treated - date
+first-in-humans study
+follow-up (clinical study)
+Food and Drug Administration (FDA)
+Form
+frequency
+frozen
+FTP
+functional roles (in a study)
+functions
+FWA
+GBP
+GCP
+GDPR
+gender
+gene therapy
+general observation class
+generalizability
+Generative AI (GenAI)
+generic name
+genetic testing
+global assessment variable
+glossary
+GLP
+GMP
+GMT
+Good Clinical Practice (GCP)
+granularity
+group sequential design
+GXP
+handwritten signature
+hazard ratio
+Health Level 7 (HL7)
+health literacy
+healthcare facility
+healthcare provider
+healthy volunteer
+HEOR
+hereditary
+HHS
+HIE
+HIMA
+HL7
+HRQoL
+HTML
+HTTP
+human subject
+hypertext
+hypothesis
+I3C
+IB
+IBD
+IC
+ICD
+ICF
+ICH
+ICMJE
+ICR
+ICSR
+IDE
+IEC
+IFPMA
+immune response
+IMP
+IMPD
+incentive
+incidence
+inclusion criteria
+IND
+independent ethics committee (IEC)
+independent variable
+indication
+informed consent
+infusion
+ingredient
+INN
+inspection
+Institutional Review Board (IRB)
+instrument
+intended use
+intention-to-treat
+intercurrent event
+interim analysis
+internal consistency
+interventional study
+investigational device
+Investigational New Drug (IND)
+investigational product
+investigator
+investigator brochure
+IRB
+ISO
+item
+IVD
+IVRS
+Janus study data repository
+JCAHO
+JPMA
+KASA
+KFDA
+label
+laboratory (clinical)
+LAN
+Large Language Model (LLM)
+last subject last visit - date
+legally acceptable representative
+life-threatening adverse event
+LLM
+LOA
+LOINC
+longitudinal study
+low-interventional clinical trial
+MA
+machine learning
+Magnetic Resonance Imaging (MRI)
+MAH
+manufacturer (drug)
+mapping
+marketing authorization
+masking
+master protocol
+maximum
+Mbps
+mean
+MedDRA
+median
+medical device
+medical monitor
+medicinal product
+Medicines and Healthcare products Regulatory Agency (MHRA)
+mega-trials
+meta-analysis
+metadata
+migration
+minimum
+missing data
+model
+monitor
+monitoring
+monitoring plan
+morbidity
+mortality rate
+MOU
+multicenter trial
+N of 1 trial
+NCE
+NCI
+negative test result
+negligible
+neoadjuvant therapy
+neural network
+new chemical entity (NCE)
+New Drug Application (NDA)
+new molecular entity (NME)
+new safety information
+NHIN
+NHLBI
+NIH
+non-compliance
+non-inferiority trial
+non-interventional study
+nonclinical study
+Notified Body (NB)
+NSCLC
+null hypothesis
+Nuremberg Code
+objective
+observation
+observer-reported outcome (ObsRO)
+ODAC
+odds ratio
+ODM
+off-label
+official protocol title
+OHRP
+open-label study
+operational definition
+opinion (IEC)
+original data
+OTC
+outcome
+outcomes research
+outliers
+overdose
+p-value
+packaging
+palliative therapy
+parallel trial
+parameter
+participant
+patient
+patient file
+Patient Reported Outcomes (PROs)
+PBRER
+PD
+PDF
+peer review
+per-protocol analysis set
+performance outcome (PerfO)
+performed activity
+period effect
+permanent data
+personal data retention
+PI
+pilot study
+placebo
+placebo-controlled study
+plain language writing
+platform trial
+PMDA
+PMS
+population
+positive test result
+post-market surveillance
+post-trial access
+postmarketing requirement (PMR)
+PPD
+PPI
+pragmatic clinical trial
+preclinical study
+prevalence
+primary endpoint
+primary objective
+principal investigator
+privacy breach
+PRO
+probability
+procedures (participants)
+processing (personal data)
+product dose
+progression-free survival
+PROMIS
+propensity score
+protocol
+protocol deviation
+protocol title
+proxy respondent
+pseudonymization
+PSUR
+psychometrics
+public protocol title
+QA
+QOL
+query
+questionnaire
+R&D
+radiopharmaceutical medicinal product
+random allocation
+random sample
+randomization
+randomized controlled trial
+RAPS
+rationale
+raw data
+RBM
+RCT
+record
+record retention
+recruitment (subjects)
+Reference Information Model (RIM)
+regenerative medicine
+registry
+regulatory authorities
+relative risk
+REMS
+replacement
+report
+repository
+rescue medications
+research hypothesis
+residual confounding
+response option
+result synopsis
+results (study)
+retrospective study
+risk
+risk-based monitoring
+risk-benefit ratio
+risks of a research study
+RNA
+route of administration (ROA)
+RR
+RWE
+SADR
+SAE
+safety
+SaMD
+sample size
+SARS-CoV-2
+SAS
+schedule of activities
+screen failure
+screening
+script
+SD
+SDTM
+SDV
+secondary endpoint
+secondary objective
+secondary sponsor
+selection bias
+self-evident change
+semantic interoperability
+SEND
+sensitivity
+sequential
+Serious Adverse Event (SAE)
+serious breach
+sex
+side effect
+sign
+single-blind study
+site investigator
+SLA
+SMART
+SmPC
+SNOMED
+SOAP
+SOC
+software
+software validation
+SOP
+source
+source data
+source data verification
+source documents
+special populations
+specificity
+SPIRIT
+sponsor
+sponsor-investigator
+SQA
+standard
+standard deviation
+standard operating procedures (SOPs)
+standard treatment
+statistical analysis plan
+statistical method
+statistical power
+statistical significance
+stem
+STF
+stochastic
+stratification
+structured product label (SPL)
+study arm
+study completion date
+Study Data Standardization Plan (SDSP)
+study design
+study feasibility
+study intervention
+study monitoring
+study participant
+study population
+study publication date
+study reimbursement
+study results
+study start date
+study statistician
+study variable
+subject completion
+subject data event
+subject identification code
+subject-reported outcome (SRO)
+submission model
+superiority trial
+surrogate endpoint
+survey
+SUSAR
+suspension (clinical trial)
+symptom
+syntactic
+synthetic data
+system
+t-test
+table of roles and responsibilities
+target enrollment
+target population
+target trial emulation
+temporary halt (clinical trial)
+term
+termination (clinical trial)
+terminology
+therapeutic area
+therapeutic effect
+therapeutic index
+time
+Tmax
+token
+tolerability
+traceability (data)
+transcription
+transition rule
+translation
+transmit
+treatment
+treatment benefit
+treatment effect
+treatment-emergent adverse event
+trial design element
+Trial Design Model
+trial site
+trial statistician
+triple-blind study
+type 1 error
+type 2 error
+UAT
+UCUM
+umbrella trial
+unblinding
+unexpected adverse drug reaction
+URL
+USDA
+use case
+user site testing (UST)
+USP
+UUID
+vaccine
+vaccine efficacy
+VAERS
+valid
+validate
+validation
+variable
+verification
+virtual
+visit
+vocabulary
+voluntary participation
+volunteer
+vulnerable subjects
+WAN
+Warning Letter
+washout period
+web browser
+web scraping
+WHO
+withdraw
+withdrawal
+WHOART
+well-being (trial subjects)
+XML
+zoonosis
+
+
+
+
+
+
+
+
+