Clinical Research Abbreviations: The Cheatsheet
When you step into the labyrinth of clinical research, you find yourself surrounded by hedge walls made of acronyms and abbreviations. The clinical world is laden with shorthand that can seem like a secret language to the uninitiated. Yet, behind these cryptic codes lie vital information crucial for patient care. This living note is my personal attempt to keep the alphabet soup of healthcare terminology under control and to unlock the secrets hidden within.
ADME: Absorption, Distribution, Metabolism, and Elimination
ADR: Adverse Drug Reaction
AE: Adverse Event
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
API: Active Pharmaceutical Ingredient
ARO: Academic Research Organization
BA/BE: Bioavailability/Bioequivalance
BLA: Biologics License Application
BSM: Biospecimen Management
CAPA: Corrective and Preventive Action
CCEA: Complete, Consistent, Enduring, Available
CCTO or CTO: Centralized Clinical Trials Office or Clinical Trials Office
CDASH: Clinical Data Acquisition Standards Harmonization
CDM: Clinical Data Management
CDP: Clinical Development Plan
CDUS: Clinical Data Update System
CFR: Code of Federal Regulations
CMO: Contract Manufacturing Organization
CRA: Clinical Research Associate
CRC: Clinical Research Coordinator
CRF: Case Report Form
CRMS: Clinical Research Management System
CRO: Contract Research Organization
CRPC: Clinical Research Process Content
CRS: Cytokine Release Syndrome
CSO: Contract Safety Organization
CSR: Clinical Study Report
CTA: Clinical Trial Authorization
CTMS: Clinical Trial Management System
CTRP: Clinical Trials Reporting Program
DDI: Drug-Drug Interaction
DLT: Dose-Limiting Toxicity
DM: Data Manager
DMC: Data Monitoring Committee
DSMB: Data and Safety Monitoring Board
EC: Ethics Committee
eCOA: Electronic Clinical Outcome Assessment
eCRF: Electronic Case Report Form
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
FIH: First In Human
GCP: Good Clinical Practice
GDP: Good Documentation Practice
GLP: Good Laboratory Practice
GMP: Good Manufacturing Practice
GVP: Good Pharmacovigilance Practice
HIPAA: Health Insurance Portability and Accountability Act
HRPP: Human Research Protection Program
IBC: Institutional Biosafety Committee
ICANS: Immune Effector Cell Associated Neurotoxicity
ICF: Informed Consent Form
ICH: International Council for Harmonization
IDE: Investigational Device Exemptions
IEC: Independent Ethics Committee
IHCRA: In House Clinical Research Associate
IIT: Investigator Initiated Trial
IND: Investigational New Drug application
IP: Investigational Product
IRB: Institutional Review Board
IRR: Infusion Related Reaction
ITT: Intent to Treat
LTFU: Long Term Follow Up
MAD: Multiple Ascending Dose
MRN: Medical Record Number
MTD: Maximum Tolerated Dose
NDA: New Drug Application
NHV: Normal Healthy Volunteer
PAC: Post Approval Commitments
PC: Protocol Coordinator
PD: Protocol Director
PHI: Protected Health Information
PI: Principal Investigator
PK/PD: Pharmacokinetic/Pharmacodynamic
PRE: Prompt Reporting Event
PRMC: Protocol Review and Monitoring Committee
PRMS: Protocol Review and Monitoring System
QC: Quality Control
QCT: Qualifying Clinical Trial
QMS: Quality Management System
RCT: Randomized Controlled Trial
RP2D: Recommended Phase 2 Dose
SAD: Single Ascending Dose
SAE: Serious Adverse Event
SC: Study Coordinator
SDR: Source Document Review (Also Source Data Review)
SDTM: Study Data Tabulation Model
SDV: Source Document Verification
SIF: Site Investigator File
SMO: Site Management Organization
SOC: Standard of Care
SOE: Schedule of Events
SOP: Standard Operating Procedure
SRB: Scientific Review Board
SRC: Scientific Review Committee
SVT: Subject Visit Template
TMF: Trial Master File (also eTMF)
TMO: Trial Management Organization
UAP: Unanticipated Problem