[Reporting adverse reactions and events in randomised clinical trials]

Ugeskr Laeger. 2010 Aug 30;172(35):2381-4.
[Article in Danish]

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.

Publication types

  • English Abstract

MeSH terms

  • Adverse Drug Reaction Reporting Systems* / legislation & jurisprudence
  • Adverse Drug Reaction Reporting Systems* / standards
  • Denmark
  • European Union
  • Guideline Adherence
  • Guidelines as Topic
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use
  • Insulin / adverse effects
  • Insulin / therapeutic use
  • Metformin / adverse effects
  • Metformin / therapeutic use
  • Randomized Controlled Trials as Topic* / standards

Substances

  • Hypoglycemic Agents
  • Insulin
  • Metformin