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					                                      ABBREVIATIONS


            Following is a brief list of common abbreviations used in the conduct of clinical trials.


            ACP                Association of Clinical Pharmacology (now ACRP)
            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




© 2002 by CRC Press LLC
            330      Clinical Research Coordinator Handbook



            DHHS               Department of Health and Human Services
            DIA                Drug Information Association
            DOD                Department of Defense
            DRG                 diagnosis-related groups
                               Division of Research Grants (NIH)
            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 Harmonisation
            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
            NA1                 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)
            OIG                 Office of the Inspector General
            OPRR                Office of Protection from Research Risks
            OSHA                Occupational Safety and Health Administration
            OTC                 over-the-counter




© 2002 by CRC Press LLC
                                                                                 Abbreviations 33 1



            PD                 pharmacodynamics
            PER1               Pharmaceutical Education and Research Institute
            PhRMA              Pharmaceutical Research and Manufacturers of America
            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. 4 (12),
            pp. 22-28, December 1995.


            The PF (Pitfalls) of B (Brevity). A. Papke, Jourrzal of Clinical Research ancl Drug
            Development, Vol. 7 (2), pp. 77-86, 1993.


            Medical Ahhreliatiorzs: 5500 Converziences at the Esperzse of Comrnunicatiorzs ancl Safety,
            4th ed. Neil M. Davis, Neil M. Davis Associates, Huntingdon Valley, Penn.




© 2002 by CRC Press LLC

				
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