Risk-Based Monitoring Case Study: Lessons from a 3,389-subject Global Phase III Trial

Applied Clinical Trials

Applied Clinical Trials logo

Health Decisions Director of Corporate Operations Lisa James’ October 6, 2015 case study for Applied Clinical Trials provides a snapshot of one risk-based monitoring (RBM) approach and lessons learned from its application in a global Phase III trial involving more than 60 sites and almost 3,400 subjects.


Given a robust implementation of RBM, sponsors should consider it a reliable way to ensure data quality in a manner that focuses on the quality of endpoint data and protects the statistical analysis defined by the protocol. If there is a risk in adoption of this novel approach to trial monitoring, it is that risk indicators based on data collected during the study will dictate aggressive monitoring to ensure meeting quality goals. Such a scenario would limit cost savings. However, based on our experience with RBM, we believe that in most cases, a rigorous implementation that includes proactive, metrics-driven site management will both ensure high data quality and deliver substantial cost savings.