Adverse event reporting in clinical trials: room for improvement.
Regulatory and ethical guidelines require clinical trial sponsors to disseminate clinical trial adverse event reports to involved investigators and human research ethics committees. Compliance with these guidelines has resulted in a major administrative burden for ethics committees. This burden does not necessarily contribute to the protection of clinical trial participants. Rationalisation of the adverse event reporting might allow better use of the data and might benefit human research ethics committees.
Liauw
Winston S
WS
Clinical Trials Centre, St Vincent's Hospital, Darlinghurst, NSW.
Day
Richard O
RO
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D001315:Australia; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods*; D032984:Ethics, Research; D019983:Guideline Adherence; D006801:Humans; D016247:Information Storage and Retrieval / Q000379:methods; D012308:Risk Management / Q000458:organization & administration*