Managing changes during a clinical investigation, Part I.
During the course of a clinical investigation, changes may need to be made to the device, the manufacturing process, the investigational plan or other aspects of the investigation. Part I of this article discusses the United States requirements for managing these types of changes. Part II will discuss European requirements and the need for developing a standard operating procedure to help ensure consistent compliance.
Donawa
Maria
M
Donawa & Associates Ltd., Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
D002986:Clinical Trials as Topic; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004864:Equipment and Supplies; D017408:Guidelines as Topic; D006801:Humans; D008422:Materials Testing; D009936:Organizational Innovation; D014481:United States; D014486:United States Food and Drug Administration