title: Inspection of clinical investigations by the German health authorities.
abstract: 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 für die ordnungsgemässe Durchführung der klinischen Prüfung, 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.
authors.affiliation: Regierungspräsidium Tübingen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Schmidt
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005858:Germany; D006805:Human Experimentation; D006801:Humans