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Clinical Trials: US FDA Should Frame Risk-Based Monitoring As Best Practice, ACRO Says

 
• By Sue Sutter

Recent Q&A draft guidance is aimed at assisting sponsors in planning and conducting risk-based approaches to monitoring, but ACRO’s Doug Peddicord says agency needs to take a more straightforward, proactive approach to encouraging the move away from 100% source data verification.

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A new US FDA draft guidance is aimed at promoting greater use of risk-based monitoring in clinical trials, but a more proactive agency stance to position risk-based monitoring (RBM) as a best practice is needed to ensure greater adoption, the head of an industry group believes.

The draft guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers,” comes five-and-a-half years after the agency finalized an initial guidance on the subject, which...

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