[Reporting adverse reactions and events in randomised clinical trials].
"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.
Hemmingsen
Bianca
B
Copenhagen Trial Unit, Center for Klinisk Interventionsforskning, Rigshospitalet, 2100 København Ø, Denmark. bh@ctu.rh.dk
Støy
Lina
L
Wetterslev
Jørn
J
Tarnow
Lise
L
Friis
Karin Bach
KB
Christensen
Louise Lundby
LL
Sales
Nader
N
Gluud
Christian
C
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000592:standards; D003718:Denmark; D005062:European Union; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000592:standards
D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin