Clinical Research and GCP Update

E6(R3) Concept Paper …

• “The action proposed is a full rewrite and reorganization of the ICH E6(R2) Guideline Good Clinical Practice (GCP)”. • “E6(R2) is not fully designed to address emerging technologies, innovations in trial design, the diversity of data sources, testing facilities, and service providers, or to address other emerging complexities of the current clinical trial climate.” • The application of the current standard to new technology is clearly challenging.

• Stakeholders may fail to take full advantage of technological innovations and the full potential of the risk-based considerations related to participant protection, data integrity or other public health considerations.

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Overview of E6(R3) Revision - Approach

• A rewrite and reorganization of ICH-E6(R2) − Principles document and Annexes − Align with ICH-E8 as appropriate − Bridge identified gaps within E6 and between E6 and relevant ICH guidances • Clear and concise scope − Expectations should be fit for purpose • Focus on key concepts − Quality by design and Risk-based approach − Proportionality − Critical to quality factors − Other…

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