We are required to implement a risk-based approach to quality management (RBQM) for clinical trials. The process has changed significantly from the traditional model of regular on-site monitoring visits. In this interactive session, after providing background, we will explore questions such as: How do you know if the process is working as you expected it to? How do you know if RBQM is having an impact? Should RBQM be able to control all risks, or should we also expect the unexpected? What other options are available to manage the unknown risks?