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Clinical Trial Acronyms and Abbreviations

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When we talk to people who are new to our industry, one of the toughest things for them to wrap their heads around is the clinical trial acronyms we use. Life science professionals use a multitude of clinical trial abbreviations, and we often rattle off a sentence packed with esoteric acronyms that we assume our listeners will be familiar with. Here is a question that came up on a call recently:

“Does GDPR contradict the FDA’s stance on remote SDV and CRFs stored in the cloud?”

Now, most people could probably tell you who the FDA is, but if you ask a layperson about SDV and CRFs and how they fit into ICH-GCP under GDPR jurisdictions, you might as well be speaking Klingon. To help, we’ve developed a list of clinical trial acronyms that we use frequently in order to make sure new hires are able to decipher the letters we throw around. If you’re new to the industry or just need to lookup an obscure clinical acronym, we hope this helps.

Clinical Trials and Medical Terminology

ACA: Affordable Care Act

ADaM: Analysis Data Model

ADR: Adverse Drug Reaction

AE: Adverse Event

ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate

AMC: Academic Medical Center

ARO: Academic Research Organization

CCEA: Complete, Consistent, Enduring, Available

CDASH: Clinical Data Acquisition Standards Harmonization

CDISC: The Clinical Data Interchange Standards Consortium

CDS: Clinical Data System

CMO: Contract Manufacturing Organization

COA: Clinical Outcome Assessments

CRA: Clinical Research Associate

CRC: Clinical Research Coordinator

CRF: Case Report Form (less frequently: Change Request Form)

CRO: Contract Research Organization

CSDD: Center for the Study of Drug Development

CSO: Contract Safety Organization

CTMS: Clinical Trial Management System

CVM: Center for Veterinary Medicine 

DDC: Direct Data Capture

DM: Data Manager

DSMB: Data and Safety Monitoring Board

eCOA: Electronic Clinical Outcome Assessments 

eCRF: Electronic Case Report Form

ePRO: Electronic Patient-Reported Outcome

EDC: Electronic Data Capture

EHR: Electronic Health Record

eICD: Electronic Consent Document

EMR: Electronic Medical Record

eSource: Electronic Source Data

eTMF: Electronic Trial Master File

FDA: Food and Drug Administration

FIH: First in Human

FPI: First Patient In

GCP: Good Clinical Practice 

GDP: Good Documentation Practices

GDPR: General Data Protection Regulation

HHS: Department of Health and Human Services

HIPAA: The Health Insurance Portability and Accountability Act

IC: Informed Consent

ICD: Informed Consent Document

ICF: Informed Consent Form

ICH: International Council for Harmonization

IEC: Independent Ethics Committee

IIT: Investigator-Initiated Trial

IND: Investigational New Drug

IRB: Institutional Review Board

MD: Doctor of Medicine

MDR: Medical Devices Regulation (EMA)

NBE: New Biopharmaceutical Entity

NCE: New Chemical Entities

NDA: New Drug Application

NIH: National Institutes of Health

OCT: Office of Clinical Trials

OHRP: Office for Human Research Protections (Overseen by the Department of Health and Human Services)

PCR: Pending Changes Report

PDUFA: Prescription Drug User Fee Act

PHI: Protected Health Information

PII: Personally Identifiable Information

Pl: Principal Investigator

PRO: Patient-Reported Outcome

RTSM: Randomization and Trial Supply Management

SAE: Serious Adverse Event

SDTM: Study Data Tabulation Model

SDV: Source Document Verification

SOP: Standard Operating Procedure

tSDV: Targeted Source Document Verification

TMF: Trial Master File

General Software Terms

API: Application Program Interface (also: Active Pharmaceutical Ingredient)

CSV:Comma-Separated Values

EDC: Electronic Data Capture

GUI: Graphical User Interface

IRT: Interactive Response Technology 

IVR: Interactive Voice Response

ODM: Operational Data Model

SaaS: Software as a Service

SAS: Statistical Analysis System

SPSS: Statistical Package for the Social Sciences

TFS: Team Foundation Server

UAT: User Acceptance Testing

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