What is 'risk-based monitoring'?

• A. Monitoring activities focused on high-risk aspects to ensure data quality and subject safety.
• B. Checking every data point for accuracy.
• C. Continuous on-site visits on a fixed schedule.
• D. Monitoring only for IP accountability.

Answer: (B)

Focusing on high-risk areas to protect data quality and participant safety. Risk-based monitoring uses data analytics and centralized monitoring to identify where problems are most likely to occur, then concentrates monitoring activities—such as targeted on-site visits, source data verification, and issue resolution—where those risks are highest. This makes monitoring more efficient and proactive, catching issues earlier and allowing resources to be allocated where they matter most. It’s not about checking every data point or sticking to a fixed on-site visit schedule, and it isn’t limited to IP accountability; those approaches don’t prioritize risk to data integrity or subject safety in the way RBM does.