Adverse event management during clinical investigations
Donawa, M.
Medical Device Technology 13(9): 36-40
2002
ISSN/ISBN: 1048-6690 PMID: 12534157 Document Number: 548203
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.