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  1. Inspection of clinical investigations by the German health authorities.

    Article - En anglais

    Based on the regulations of the German Drug Law of 1976 (Arzneimittelgesetz, AMG) the inspections of clinical investigations by the competent health authorities focus on the protection of the human being taking part in the trial.

    Standards for the planning, methodology, conduct, report and documentation of clinical trials are laid down in a guideline (Grundsätze fur die ordnungsgemässeDurrhführung der klinischen Prüffung, Dec, 1987), a kind of national GCP standard which has to be respected by sponsors, physicians and authorities, not only for inspection but also for drug registration.

    Mots-clés Pascal : Législation, Recommandation, Essai clinique, Exploration clinique, Allemagne, Europe

    Mots-clés Pascal anglais : Legislation, Recommendation, Clinical trial, Clinical investigation, Germany, Europe

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

    Cote : 93-0478590

    Code Inist : 002B02A. Création : 199406.