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