Managing clinical data for worldwide acceptance.
Manufacturers conducting clinical studies to support medical device safety and performance claims need to ensure that clinical study data are appropriately managed. Not doing so can risk the success of the project related to the clinical study. This article discusses a guideline that can assist in this effort.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D002986:Clinical Trials as Topic / Q000592:standards*; D016208:Databases, Factual / Q000592:standards*; D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D016247:Information Storage and Retrieval / Q000592:standards*; D038622:Internationality