What's the difference between Risk Based Monitoring & Risk Based Quality Management?

RBM and RBQM are related, but they are not the same!

RBM focuses mainly on monitoring activities and the use of signals to direct site and data review, whereas RBQM starts earlier and provides the broader quality management framework across the study lifecycle.

RBM can support RBQM, but it does not replace it.

Updated on: 31/07/2026