Adverse event management during clinical investigations.
The requirements are changing for documentation and evaluation of adverse events that occur during clinical investigations of medical devices. This article discusses important amendments to adverse event definitions contained in a draft international standard and methods for improving the process of managing these types of events.
Donawa
Maria
M
Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
D002986:Clinical Trials as Topic / Q000592:standards*; D004282:Documentation / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies / Q000009:adverse effects*; D005060:Europe; D006801:Humans; D014481:United States