Header image for the post titled 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