Short List of Commonly Used Acronyms in Clinical Research


Short List of Commonly Used Acronyms in Clinical Research

700U  Statement of Economic Interest

ACRP  Association of Clinical Research Professionals

AE  Adverse Event

ADR  Adverse Drug Reaction

AMA  American Medical Association

BID  Twice Daily

BIND  BiologicalIND

CAP Collegeof American Pathologists

CBCTN Community Based Clinical Trials Network

CBER Centerfor Biologics Evaluation and Research (FDA)

CCRA  Certified Clinical Research Associate (ACRP)

CCRC  Certified Clinical Research Coordinator (ACRP)

CCRC  CTSC ClinicalResearchCenter

CCRP  Certified Clinical Research Professional (SoCRA)

CDA  Confidential Disclosure Agreement

CDC Centerfor Disease Control

CDER Centerfor Drug Evaluation and Research (FDA)

CDRH Centerfor Devices and Radiological Health (FDA)

CF  Consent Form

CFR  Code of Federal Regulations

CLIA  Clinical Laboratory Improvement Amendments

CME  Continuing Medical Education

CP  Compliance Program (FDA)

COI  Conflict of Interest

CRA  Clinical Research Associate CTSC Clinical Research Training Program

CRC  Clinical Research Coordinator

CRF  Case Report Form

CRO  Clinical Research Organization

CT  Clinical Trial

CTA  Clinical Trial Agreement

CS  Clinically Significant

CSA  Clinical Service Agreement

CTSC  Clinical and TranslationalScienceCenter

CV   Curriculum Vitae

DCF  Data Correction Form / Data Clarification Form

DEA  Drug Enforcement Agency (law enforcement division of FDA)

DHHS  Department of Health & Human Services

DOS  Description of Study

EAB  Ethical Advisory Board (similar to IRB, used by other nations)

EDC  Electronic Data Capture

FDA  Food and Drug Administration

FDA-482 Notice of Inspection

FDA-483 Notice of Adverse Findings in an Inspection

FDA-1572 FDA Form for New Drug Application

FDA-1572 FDA Form for Statement of Investigator

FDA-SRS Spontaneous Reporting System of the FDA

FDCA  Food, Drug, and Cosmetic Act

FOIA  Freedom of Information Act

FTC Federal Trade Commission

GCP  Good Clinical Practice

GDA  Global Disclosure Agreement

GLP  Good Laboratory Practice CTSC Clinical Research Training Program


GMP  Good Manufacturing Practice

HIPAA  Health Insurance Portability and Accountability Act

HHS  Health and Human Services (Department of)

HMO  Health Maintenance Organization

IACUC  Institutional Animal Care and Use Committee (IRB for animal use)

IB  Investigator’s Brochure


ICF Informed Consent Form

ICH International Conference on Harmonisation

IDB Investigational Drug Brochure

IDE Investigational Device Exemption

IDS Investigational Drug Service (pharmacy)

INAD Investigational New Animal Drug (FDA)

INDInvestigational New Drug

IRB Institutional Review Board

JCAHO Joint Commission of Accreditation of Health Care Organizations

LOA Letter of Agreement

MDR Medical Device Reporting

MOU Memoranda of Understanding

MRA Medical Research Associate

NAI No Action Indication (most favorable post-FDA inspection classification)

NCI National Cancer Institute

NCS Not Clinically Significant

NDA New Drug Application

NHLBI National Heart, Lung, and Blood Institute

NIAID National Institute of Allergy and Infectious Diseases CTSC Clinical Research Training Program


NIH National Institutes of Health

NIMH National Institute of Mental Health

NKA No Known Allergies

OAI Official Action Indicated (serious post-FDA inspection classification)

OHRP Office for Human Research Protection

OSHA Occupational Safety and Health Administration

OTC Over-the-counter (non-prescription drugs)

OVCR Office of the Vice Chancellor for Research


PD Pharmacodynamics

PDQ Physician’s Data Query (NCI sponsored cancer trial registry)

PDR Physician’s Desk Reference

PE Physical Examination

PHI Protected Health Information

PI Package Insert

PI Principal Investigator

PK Pharmacokinetics

PLA Product License Application (when seeking commercialization of a biologic)

PMA Pre-Market Approval (when seeking commercialization of a device)

POBy Mouth

PPE Personal Protective Equipment

PPI Patient Package Inserts

PPO Preferred Provider Organization

PRN As Needed

QA Quality Assurance

QC Quality Control

QD Every day CTSC Clinical Research Training Program


QID Four Times a Day

QOL Quality of Life

R&D Research and Development

RDE Remote Data Entry

RL Regulatory Letter (post-FDA audit letter)

Rx. Prescription

SAE Serious Adverse Event

SC Study Coordinator

SD Source Document

SMO Site Management Organization

SoCRA Society of Clinical Research Associates

SOMSchoolof Medicine

SOP Standard Operating Procedure

SRA Staff Research Associate

TID Three Times a Day

UNK Unknown


VAUnited StatesDepartment of Veterans Affairs

VAI Voluntary Action Indicated (post-FDA audit inspection classification)

VS Vital Signs

WHO World Health Organization

WL Warning Letter

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