"Good clinical practice" (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial.
Ugeskrift for Laeger, 2010, Vol 172, Issue 35, p. 2381-4
Adverse Drug Reaction Reporting Systems; Denmark; European Union; Guideline Adherence; Guidelines as Topic; Humans; Hypoglycemic Agents; Insulin; Metformin; Randomized Controlled Trials as Topic