The ICH Guideline for Good Clinical Practice E6(R2) addendum states that “sponsors should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring.”

During this session, we will explore how sponsors are implementing centralized monitoring and what sites need to know about the new approach.

The session will begin with a presentation about common site-level key risk indicator (KRI) metrics being reviewed during the study conduct.

Following the presentation, a panel will discuss how results are used to identify systematic errors and trigger targeted remote and on-site monitoring visits and why it is important for sites to know how they are performing relative to their peers.