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  1. FDA audits of clinical studies : policy and procedure.

    Article - En anglais

    The Food and Drug Administration has been conducting audits of the work of clinical investigators since 1962, and has done so on routine basis since 1977.

    The required information included, in addition to protocols, the identification and qualifications of proposed investigators and data on preclinical and previous clinical studies of the drug in question.

    Thus the FDA could modify or reject proposed studies deemed to present unacceptable risk.

    Mots-clés Pascal : Amérique du Nord, Amérique, Essai clinique, Contrôle qualité, Organisation santé, Etats Unis, Médicament, Réglementation, Audit

    Mots-clés Pascal anglais : North America, America, Clinical trial, Quality control, Public health organization, United States, Drug, Regulation, Audit

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 91-0020881

    Code Inist : 002B30D. Création : 199406.