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Does Risk-Based Monitoring Cheat In Source Data Verification?



Because risk-based monitoring does not involve 100% source data verification (SDV), unlike traditional monitoring, it’s understandable that RBM could seem sort of like “cheating.” But, research has shown that 100% SDV does not consistently result in higher quality data. In other words, the cost of 100% SDV outweighs the potential benefits. 

RBM aims to make the SDV that IS performed really, truly count. In an RBM strategy, SDV is reserved for the data that’s most critical to the study or most likely to be recorded wrong. In situations where SDV is warranted, it’s performed precisely and in-depth. In situations where SDV is NOT warranted, the resources aren’t wasted. So, when you think about it, RBM is really about trimming waste, not cutting corners.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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