title: [The inspection by the Danish Medical Products Agency of drug clinical trials].
abstract: An official review by the regulatory authorities of the conduct of a clinical trial is called a GCP-inspection and is an important element of Good Clinical Practice. The Danish Medicines Agency initiated GCP-inspections in Denmark in 1992. The article gives a short description of the inspections together with a few examples of findings during the inspections.
authors.forename: Erik
authors.initials: E
authors.lastname: Jacobsen
authors.forename: Irene
authors.initials: I
authors.lastname: Stilbo
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D003718:Denmark; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods / Q000458:organization & administration*; D016903:Drug Monitoring / Q000379:methods / Q000592:standards; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D006077:Government Agencies; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000331:legislation & jurisprudence