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 ACRONYMS Every Clinical Programmer (CDISC/CDASH)Should Know
