Clinical ACRONYMS Every Clinical Programmer (CDISC/CDASH)Should Know
Whether you’re new to the clinical world, or an experienced in clinical field, here is a combined list of general abbreviations you may come across.
ADaM: Analysis Data Model
ADME: Absorption, Distribution, Metabolism, and Elimination
ADR: Adverse Drug Reaction
AE: Adverse Event
API: Active Pharmaceutical Ingredient
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
BA/BE: Bioavailability/Bioequivalence
BLA: Biological Licensing Application
CAPA: Corrective and Preventive Action
CCEA: Complete, Consistent, Enduring, Available
CE: Clinical Events
CDASH: Clinical Data Acquisition Standards Harmonization
CDM: Clinical Data Management
CBER: Center for Biologics Evaluation and Research
CCR: Center for Cancer Research
CDISC: The Clinical Data Interchange Standards Consortium
CDER: Center for Drug Evaluation and Research
CCTO or CTO: Centralized Clinical Trials Office or Clinical Trials Office
CDP: Clinical Development Plan
CDS: Clinical Data System
CDUS: Clinical Data Update System
CFR: Code of Federal Regulations
CMO: Contract Manufacturing Organization
COA: Clinical Outcome Assessment / eCOA: Electronic Clinical Outcome Assessment
CRA: Clinical Research Associate
CRC: Clinical Research Coordinator
CRF: Case Report Form / eCRF: Electronic Case Report Form
CRMS: Clinical Research Management System
CRO: Contract Research Organization
CSR: Clinical Study Report
CTA: Clinical Trial Authorization
CTMS: Clinical Trial Management System
CTCAE: Common Terminology Criteria for Adverse Events
CTRP: Clinical Trials Reporting Program
DDI: Drug-Drug Interaction
DM: Data Manager
DM: Demographics
DS: Disposition
DMC: Data Monitoring Committee
DSMB: Data and Safety Monitoring Board
DLT: Dose Limiting Toxicity
DV: Protocol Deviations
EC: Ethics Committee
EDC: Electronic Data Capture
EHR: Electronic Health Record
EMR: Electronic Medical Record
ePRO: Electronic Patient-Reported Outcomes
eTMF: Electronic Trial Master File
FAIR: Findable, Accessible, Interoperable, Reusable
FDA: Food and Drug Administration
FE: Food Effect
FIH: First In Human
FPI: First Patient In
GCP: Good Clinical Practices
GDPR: General Data Protection Regulation
IND: Investigational New Drug Application
IC: Informed Consent
ICD: Informed Consent Document
ICF: Informed Consent Form
ICH: International Council for Harmonization
IEC: Independent Ethics Committee
IP: Investigational Product
IRB: Institutional Review Board
ITT: Intent to Treat
IVRS: Interactive Voice Response System
IWRS: Interactive Web Response System
LB: Laboratory Data
LTFU: Long Term Follow Up
MAD: Multiple Ascending Dose
MedDRA: Medical Dictionary for Regulatory Activities
MCS: Multi Centre Study
MTD: Maximum Tolerated Dose
MSS: Multi-Site Study
MSG: Metadata Submission Guideline
NCI: National Cancer Institute
NDA: New Drug Application
NHV: Normal Healthy Volunteer
NIH: National Institutes of Health
OSR: Outside Safety Report
ODM: Operational Data Model Team
PHI: Protected Health Information
PI: Principal Investigator
PII: Personally Identifiable Information
PD: Pharmacodynamics
PFS: Progression-Free Survival
RECIST: Response Evaluation Criteria in Solid Tumors (Oncology )
RCT: Randomized Controlled Trial
PC/PP: Pharmacokinetics Concentrations/Parameters
PK/PD: Pharmacokinetic/Pharmacodynamic
PRMC: Protocol Review and Monitoring Committee
QC: Quality Control
QCT: Qualifying Clinical Trial
SAD: Single Ascending Dose
SAE: Serious Adverse Event
SC: Study Coordinator
SDR: Source Data Review
SDS: Submission Data Standards Team
SDTM: Study Data Tabulation Model
SDV: Source Document Verification
SIF: Site Investigator File
SLA: Service Level Agreement
SMO: Site Management Organization
SMM: Submission Metadata Model
SOC: Standard of Care
SOE: Schedule of Events
SOP: Standard Operating Procedure
SRB/C: Scientific Review Board/Committee
SUSAR: Suspected Unexpected Serious Adverse Reaction
SV: Subject Visits
SVT: Subject Visit Template
TR: Tumor Results
TU: Tumor Identification
TTE: Time-to-Event Analysis
TMO: Trial Management Organization
UADE: Unanticipated Adverse Device Effect
UADR: Unexpected Adverse Drug Reaction
VS: Vital Signs
General Software Terms
API: Application Program Interface (also: Active Pharmaceutical Ingredient)
CSV: Comma-Separated Values
EDC: Electronic Data Capture
GUI: Graphical User Interface
HTML: Hyper Text Markup Language
IRT: Interactive Response Technology
IVR: Interactive Voice Response
SaaS: Software as a Service
SAS: Statistical Analysis System
SPSS: Statistical Package for the Social Sciences
TFS: Team Foundation Server
UAT: User Acceptance Testing
Other Terminologies
REFERENCES:
Clinical Trials Terminology
Introduction to Clinical Trials
An Introduction to the Standard Data Tabulation Model (SDTM)
Link between Clinical Research and SDTM
Legacy clinical data for CDISC SDTM compliance and Data Unification
AMALGAMATION OF BIG DATA ANALYTICS, SDTM, LEGACY CLINICAL DATA
Analysis DataModel Implementation Guide(ADaMIG)