mindsON RBQM Workshop | Episode 46: Why do people still think 100% SDV is gold standard quality?

Why Do People Still Think 100% SDV Is the Gold Standard for Quality?

Many clinical trial teams continue to view 100% Source Data Verification (SDV) and 100% Source Data Review (SDR) as the lowest-risk approach to quality. Yet evidence increasingly shows the limited value of blanket SDV, given the significant resources required, while SDR is better positioned as a tool for understanding site processes rather than a default quality safeguard.

This episode of mindsON RBQM challenges long-standing assumptions around SDV and SDR. The session explores why these practices persist, what the evidence says about their effectiveness, and how RBQM offers more targeted, risk-based alternatives.

Led by Johann Proeve, Chief Scientific Officer at Cyntegrity, and Keith Dorricott, MBB, Lead Instructor at Cyntegrity, this interactive session encourages open discussion and shared learning.

Participants are invited to:

• Examine the real value and limitations of 100% SDV and SDR

• Discuss how RBQM supports more focused, efficient quality oversight

• Share perspectives through live polling and whiteboards

• Explore ways to help teams move away from default SDV/SDR practices

Whether you want to contribute your experience or simply listen and learn, this session offers a practical forum for rethinking quality oversight in clinical trials.