[Public GCP unit--experiences from the Aarhus University Hospital]
[Article in
Danish]
Affiliations
- PMID: 12756826
Item in Clipboard
[Public GCP unit--experiences from the Aarhus University Hospital]
[Article in
Danish]
Ugeskr Laeger.
.
Abstract
According to the EU GCP-directive, all clinical trials involving medical products must adhere to the GCP-standards by May 2004. This may entail difficulties for investigator-initiated trials not sponsored by the industry. A public GCP-unit was established at Aarhus University Hospital in 1995. The unit offers researchers a monitoring system including discussion of the protocol, check of formalities, and verification of data and protocol compliance. As a contribution to the future work with GCP, experience from the GCP-unit at Aarhus University Hospital is presented here.
Similar articles
-
[How to establish GCP-units in Denmark?].Ugeskr Laeger. 2003 Apr 14;165(16):1665-7. Ugeskr Laeger. 2003. PMID: 12756825 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.
-
Status of the GCP guidelines in Europe.Methods Find Exp Clin Pharmacol. 1993 May;15(4):223-8. Methods Find Exp Clin Pharmacol. 1993. PMID: 8361259
-
Experiences with GLP/GCP from the pharmaceutical industry's viewpoint.Methods Find Exp Clin Pharmacol. 1993 May;15(4):233-6. Methods Find Exp Clin Pharmacol. 1993. PMID: 8361261 Review.
Publication types
MeSH terms
LinkOut - more resources
Medical
Research Materials