Sponsored Projects Administration

New FDA Guidance Calls for Increased Emphasis on Centralized Trial Monitoring

Published August 12, 2013 by OSP


A new guidance document released by the US Food and Drug Administration on 6 August 2013 calls on sponsors to develop centralized risk-based monitoring strategies for clinical trials involving medical products with the ultimate goal of enhancing protections for human subjects while simultaneously improving the quality of clinical trial data.

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