Randomised clinical trials are another form of primary data collection. There are numerous textbooks and publications on methodological and operational aspects of clinical trials and they are not covered here. An essential guideline on clinical trials is the European Medicines Agency (EMA) Note for Guidance on Good Clinical Practice, which specifies obligations for the conduct of clinical trials to ensure that the data generated in the trial are valid.
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|