[The inspection by the Danish Medical Products Agency of drug clinical trials]
[Article in
Danish]
- PMID: 12756822
Item in Clipboard
[The inspection by the Danish Medical Products Agency of drug clinical trials]
[Article in
Danish]
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.
Similar articles
-
[The role of the Danish Medical Products Agency in clinical trials].Ugeskr Laeger. 2003 Apr 14;165(16):1653-6. Ugeskr Laeger. 2003. PMID: 12756821 Danish.
-
[The GCP directive--consequences for clinical drug research].Ugeskr Laeger. 2003 Apr 14;165(16):1662-4. Ugeskr Laeger. 2003. PMID: 12756824 Danish.
-
[ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives].Ugeskr Laeger. 2003 Apr 14;165(16):1659-62. Ugeskr Laeger. 2003. PMID: 12756823 Review. Danish.
-
[How to establish GCP-units in Denmark?].Ugeskr Laeger. 2003 Apr 14;165(16):1665-7. Ugeskr Laeger. 2003. PMID: 12756825 Danish.
-
The impact of escalating regulatory requirements on the conduct of clinical research.Cytotherapy. 2003;5(4):309-13. doi: 10.1080/14653240310002225. Cytotherapy. 2003. PMID: 12944237 Review.
Publication types
MeSH terms
LinkOut - more resources
Medical