mindsON RBQM Workshop | Episode 36: Trial-Level Risks – Should you use a KRI, a QTL, or Acceptable Ranges?

Understanding Trial-Level Risk Monitoring: KRIs, QTLs, and Acceptable Ranges

In clinical trials, understanding how to monitor risks effectively is crucial for ensuring quality and compliance. But should Key Risk Indicators (KRIs) ever be used at the trial level, or is it better to focus solely on Quality Tolerance Limits (QTLs)? The latest ICH E6(R3) guidelines introduce the concept of Acceptable Ranges at the trial level, adding another layer to the risk management conversation.

Join seasoned experts Johann Proeve and Keith Dorricott as they unpack these concepts, sharing practical insights on when and how to apply KRIs, QTLs, and Acceptable Ranges in trial-level risk monitoring. This session will help you understand the roles of each tool, their differences, and how to integrate them into your RBQM framework to meet regulatory expectations while optimizing clinical trial oversight.

This interactive workshop encourages active participation through live polling and whiteboards, offering you the opportunity to share your views, ask questions, and engage with peers. Whether you’re new to risk-based quality management or looking to deepen your expertise, this session is designed to provide valuable guidance on navigating trial-level risks with confidence and clarity.