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Risk - Based Monitoring for Late - Phase Research: Strategies for Real - World, Post - Approval Studies

Published 19 September 2014 | By PRA Health Sciences

The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection and overall study quality and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV).

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Risk - Based Monitoring for Late - Phase Research: Strategies for Real - World, Post - Approval Studies