title: [Reporting adverse reactions and events in randomised clinical trials].
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.
authors.affiliation: Copenhagen Trial Unit, Center for Klinisk Interventionsforskning, Rigshospitalet, 2100 København Ø, Denmark. bh@ctu.rh.dk
authors.forename: Bianca
authors.initials: B
authors.lastname: Hemmingsen
authors.forename: Lina
authors.initials: L
authors.lastname: Støy
authors.forename: Jørn
authors.initials: J
authors.lastname: Wetterslev
authors.forename: Lise
authors.initials: L
authors.lastname: Tarnow
authors.forename: Karin Bach
authors.initials: KB
authors.lastname: Friis
authors.forename: Louise Lundby
authors.initials: LL
authors.lastname: Christensen
authors.forename: Nader
authors.initials: N
authors.lastname: Sales
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
mesh_terms: 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
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin