title: Adverse event management during clinical investigations.
abstract: 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.
authors.affiliation: Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: 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