ACRP: Association of Clinical Research Professional

ADR: Adverse Drug Reaction

AE: Adverse Events/Adverse Experience

CDM: Clinical Data Management

CFR: Code of Federal Regulations

CGMP: Current Good Manufacturing Practice

CLIA: Clinical Laboratory Improvements Amendments

CRA: Clinical Research Associate

CRC: Clinical Research Coordinator

CRF: Case Report Forms

CRO: Contract Research Organization

CSO: Consumer Safety Officer

CSR: Clinical Study Report

CV:    Curriculum Vitae

DB:    Double Blind

DE:    Data Entry

DEA: Drug Enforcement Administration

DHHS: Department of Health and Human Services

DIA: Drug Information Association

DMF: Drug Master File

DRG: Data Review Guidelines

DV:    Data Verification

EC:    Ethical Committee

ECG: Electrocardiogram

ED: Effective Data

FDA: Food & Drug Administration

FD&C: Federal Food, Drug, and Cosmetic Act of 1938

FPL: Final Product/Printed Labeling

GCP: Good Clinical Practice

GLP: Good Laboratory Practice

HIV: Human Immunodeficiency Virus

IB:   Investigator Brochure

IC:   Informed Consent

ICD-9: International Classification of Diseases 9th Edition

ICF: Informed Consent Form

ICH: International Conference on Harmonization

IDDM: Insulin Dependent Diabetes

IDE: Investigational Device Exemption

IDR: Idiosyncratic Drug Reaction

IEC: Independent Ethical Committee

IND: Investigational New Drug Application

IPRO: Independent Pharmaceutical Research Organization

IRB: Institutional Review Board

ISO: International Standards Organization

IVD: In Vitro Device/Diagnostics

LD:    Lethal Dose

LOA: Letter of Agreement

LOI: Letter of Intent

MOU: Memorandum of Understanding

MRA: Medical Research Association

MTD: Maximum Tolerated Dose

NAF: Notice of Adverse Findings (FDA post-audit letter)

NAI: No Action Indicated

NCE: New Chemical Entity

NCI: National Cancer Institute

NCR: No Carbon (paper) Required

NDA: New Drug Application

NDC: National Drug Code

NDS: New Drug Study (Canada)

NF:    National Formulary

NHS: National Health Service (UK)

NIH: National Institute of Health

NME: New Molecular Entity

NTP: National Toxicology Program

OAI: Official Action Indicated

OGD: Office of Health Affair

OSHA: Occupational Safety Health Administration

OTC: Over the Counter

PD:    Pharmacodynamics

PDR: Physician’s Desk Reference

PI:   Principle Investigator

PK:   Pharmacokinetics

PMA: Pharmaceutical Manufacturer’s Association

PMS: Post-marketing Surveillance

PPI: Patient Package Insert

PRC: Protocol Review Committee

PRN: As needed

QA: Quality Assurance

QAU: Quality Assurance Unit

QC: Quality Control

QD: Two Times Daily

QID: Four Times Daily

QOL: Quality of Life

R&D: Research and Development

RDE: Remote Data Entry

RL: Regulatory Letter

SAE: Serious Adverse Events

SAS: Statistical Analysis Software

SC: Study Coordinator

SMDA: Safe Medical Device Act of 1990

SNDA: Supplementary New Drug Application

SOP: Standard Operation Procedures

SUD: Sudden Unexpected Death

WHO: World Health Organization