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Whitepapers

Is FDA Changing Its Philosophy on Sponsor Monitoring of Clinical Trials?

Does publication of its Draft Industry Guidance, Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring, signal a shift in FDA’s philosophy of the monitoring of clinical studies for device approvals? In the guidance document, FDA states it wants to make clear that “sponsors can use a variety of approaches to fulfill their responsibilities” and will encourage strategies that “reflect a modern, risk-based approach specifically encouraging greater use of centralized monitoring methods where appropriate.”