ABSTRACT

Drug Information Association Department of Defense diagnosis-related groups Division of Research Grants (NIH) Data and Safety Monitoring Board European Commission Establishment Inspection Report Food and Drug Administration Food and Drug Law Institute Good Clinical Practice Good Laboratory Practice Good Manufacturing Practice (U.S. Department of) Health and Human Services International Conference on Harmonization Investigational Device Exemption Independent Data Monitoring Committee Investigational New Drug (Application) Institutional Review Board Joint Commission for the Accreditation of Hospitals maximum tolerated dose notice of adverse findings no action indicated New Chemical Entity New Drug Application National Institutes of Health New Molecular Entity official action indicated Office of Human Research Protection (formerly OPRR) Office of Human Research Trials Office of Human Subject Protection Office of the Inspector General Office of Protection from Research Risks Occupational Safety and Health Administration

OTC PD PER1 PhRMA PHS PI

PK PLA PMA PP1 RDE SMO SOP SUD TIND TMO VAI WHO WHOART

over-the-counter pharmacodynamics Pharmaceutical Education and Research Institute Pharmaceutical Research and Manufacturers of America Public Health Service Principal Investigator package insert pharmacokinetics Product License Application Premarket Approval (application) patient package insert remote data entry site management organization Standard Operating Procedure sudden unexpected death Treatment Investigational New Drug trial management organization voluntary action indicated World Health Organization World Health Organization Adverse Reaction Terminology

Resources for additional abbreviations:

Glossary: Acronyms, Abbreviations, and Initials. Applied Clinical Trials, Vol. 9 (12), pp. 24-28, December 2000.