ABSTRACT
ACRP Association of Clinical Research Professionals ADE Adverse Drug Experience ADME absorption, distribution, metabolism, excretion ADR Adverse Drug Reaction AE Adverse Event, Adverse Experience ANDA Abbreviated New Drug Application BSA body surface area CANDA Computer-Assisted New Drug Application CBER Center for Biologics Evaluation and Research CCRA Certified Clinical Research Associate CCRC Certified Clinical Research Coordinator CDC Centers for Disease Control CDER Center for Drug Evaluation and Research CFR Code of Federal Regulations CLIA Clinical Laboratory Improvements Amendments COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms CRA Clinical Research Associate CRC Clinical Research Coordinator CRF Case Report Form, Case Record Form CRO Contract Research Organization CTA Clinical Trial Agreement CTX Clinical Trial Exemption CV curriculum vitae DHHS Department of Health and Human Services
DIA
DSMB Data and Safety Monitoring Board EC European Commission EIR Establishment Inspection Report FDA Food and Drug Administration FDLI Food and Drug Law Institute GCP Good Clinical Practice GLP Good Laboratory Practice GMP Good Manufacturing Practice HHS (U.S. Department of) Health and Human Services ICH International Conference on Harmonization IDE Investigational Device Exemption IDMC Independent Data Monitoring Committee IND Investigational New Drug (Application) IRB Institutional Review Board JCAH Joint Commission for the Accreditation of Hospitals MTD maximum tolerated dose NAF notice of adverse findings NAI no action indicated NCE New Chemical Entity NDA New Drug Application NIH National Institutes of Health NME New Molecular Entity OAI official action indicated OHRP Office of Human Research Protection (formerly OPRR) OHRT Office for Human Research Trials OHSP Office for Human Subject Protection OIG Office of the Inspector General OPRR Office of Protection from Research Risks OSHA Occupational Safety and Health Administration
PD PHS Public Health Service PI Principal Investigator
package insert PK pharmacokinetics PLA Product License Application PMA Premarket Approval (Application) PPI patient package insert RDE remote data entry SMO site management organization SOP Standard Operating Procedure SUD sudden unexpected death TIND Treatment Investigational New Drug TMO trial management organization VAI voluntary action indicated WHO World Health Organization WHOART 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.
