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Section 5.20.1 of ICH E6(R2) refers to root cause analysis for significant noncompliances in clinical trials. This should lead to corrective and preventive actions. Does this relate at all to section 5.0 on Risk-Based Quality Management? After all, isn’t a risk a potential issue? And where an issue has occurred, the actions taken to reduce the likelihood or impact of recurrence are risk controls, aren’t they? Can you use historical data on issues to help with risk evaluation and control? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

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