Risk-Based Monitoring (RBM) is a monitoring approach that prioritizes oversight activities based on the areas of highest risk to participant safety and data integrity.
RBM uses risk assessments and centralized analytics to focus monitoring on critical data and processes rather than routine 100% verification of all data points. This model often combines centralized monitoring with targeted on-site visits to address site-specific signals such as high deviation rates or data anomalies. RBM supports efficiency while maintaining or improving quality by concentrating resources where they have the greatest impact. When documented and executed well, RBM strengthens oversight defensibility and aligns with modern regulatory expectations for quality-by-design.