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Reporting adverse reactions and events in randomised clinical trials

Hemmingsen, B.; Støy, L.; Wetterslev, Jørn.; Tarnow, L.; Friis, K.Bach.; Christensen, L.Lundby.; Sales, N.; Gluud, C.; Madsbad, S.; Snorgaard, O.; Røder, M.; Thorsteinsson, B.; Gade-Rasmussen, B.; Jarløv, A.; Sneppen, S.; Duun, E.; Jensen, T.; Mathiesen, E.; Perrild, H.; Krarup, T.; Vestergaard, H.; Nielsen, F.; Hedetoft, C.; Breum, L.; Christensen, L.Lundby.; Lund, Søren.S.; Boesgaard, T.W.; Tarnow, L.; Pedersen, O.; Vaag, A.; Almdal, T.; Hemmingsen, B.; Wetterslev, Jørn.; Gluud, C.; Hans

Ugeskrift for Laeger 172(35): 2381-2384

2010

ISSN/ISBN: 0041-5782
PMID: 20825743
Document Number: 640094
"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.

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