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Guidance on Data Retention on Withdrawn Trial Participants

12/01/2008

Federal Register Notice: FDA is making available a guidance, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials, which clarifies the agency’s position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product. This includes participants who are withdrawn by their legally authorized representative or those were discontinued from participation by the clinical investigator. To download this guidance, click here. To view this notice, click here.

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