With feedback from the FDA, the Protocol Deviations team proposes a revised definition of important protocol deviations and developed three tools to help clarify the definition and multiple processes of protocol deviation management: from identification through reporting including several feedback loops.
The Protocol Deviations Toolkit has been designed to provide a holistic approach to PD Management, including a proposed clarified definition of important deviations, application of ICH E6 (R2) risk-based and issue management components, and end-to-end process components.
We are seeking comment from additional industry stakeholders to affirm that application could mitigate current challenges across the multiple facets of PD management. The Public Comment period will run through November 11.
Have feedback on our Protocol Deviations Toolkit?
Protocol Deviations Toolkit
Click on each element below to learn more