Clinical Trial Monitoring Not Ready To Go Completely Off-Site, FDA Says
Agency yields to some, denies other industry requests in final guidance that declines to lay out one prescriptive monitoring path.
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Recent Q&A draft guidance is aimed at assisting sponsors in planning and conducting risk-based approaches to monitoring, but ACRO’s Doug Peddicord says agency needs to take a more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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