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.

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Protocol Deviations Toolkit

Click on each element below to learn more

Title

Description

A proposed framework describing flexible Protocol Deviations management approaches, elements for consideration based upon proposed interpretation of the ICH E3 definition for important protocol deviations and other associated PD Guidance with links to the PD Process.

A map of the proposed PD management process containing processes for both important and non-important deviations and feedback loops.

A template to assist in the identification and documentation of protocol specific ‘important’ deviations.

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