Managing changes during a clinical investigation, Part II.
What are the European requirements for managing changes that may occur during a clinical investigation? Part II of this article discusses these requirements and the development of 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 / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D009936:Organizational Innovation