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. 2003 Apr 14;165(16):1656-8.

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

[Article in Danish]
Erik Jacobsen, Irene Stilbo
  • PMID: 12756822

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

[Article in Danish]
Erik Jacobsen et al. Ugeskr Laeger. .

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.

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