The inspection by the Danish Medical Products Agency of drug clinical trials

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 tog...

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Bibliographic Details
Published inUgeskrift for læger Vol. 165; no. 16; p. 1656
Main Authors Jacobsen, Erik, Stilbo, Irene
Format Journal Article
LanguageDanish
Published Denmark 14.04.2003
Subjects
Adverse Drug Reaction Reporting Systems - legislation & jurisprudence
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - standards
Denmark
Drug and Narcotic Control - legislation & jurisprudence
Drug Approval - legislation & jurisprudence
Drug Approval - methods
Drug Approval - organization & administration
Drug Monitoring - methods
Drug Monitoring - standards
Government Agencies
Guidelines as Topic
Humans
Informed Consent - legislation & jurisprudence
Research Subjects - legislation & jurisprudence
Denmark
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Summary: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.
ISSN:0041-5782