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Ugeskr Laeger. 2010 Aug 30;172(35):2381-4.

[Reporting adverse reactions and events in randomised clinical trials].

[Article in Danish]

Author information

1
Copenhagen Trial Unit, Center for Klinisk Interventionsforskning, Rigshospitalet, 2100 København Ø, Denmark. bh@ctu.rh.dk

Abstract

"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.

PMID:
20825743
[Indexed for MEDLINE]

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