RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is proportionality: monitoring intensity and quality controls are aligned to the risks that matter for subject safety and decision-making endpoints, rather than applying uniform, resource-intensive methods such as blanket 100% source data verification. RBQM centers on identifying Critical-to-Quality (CtQ) factors, establishing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), and using centralized analytics and targeted on-site activities to address high-priority issues.