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Human Subjects Division (HSD)

Regulatory Updates

FDA Issues Draft Guidance on Risk-Based Approaches for Monitoring Clinical Investigations

Aug 30, 2011 at 6:57am

FDA has issued draft guidance on "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring." The guidance document is now available from the FDA's web site using the following web link:


The new draft guidance is being issued to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof.  This guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities during clinical investiations. This guidance describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to effectively oversee a study.

Comments to this draft guidance are due by November 28, 2011.