ICH E8(R1) Final Version Released on April 7, 2022
With the release of the final ICH E8(R1) version this month, sponsors and CROs are encouraged to embrace a Quality by Design culture. This final paper is part of a more general Good Clinical Practice (GCP) “Renovation” that involves the modernization of ICH E8 and subsequent renovation of ICH E6.
- Download the full paper here: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1)
- Read also: How the New ICH E8(R1) Guidance Affects Your Clinical Operations
- Free infographic: ICH E8(R1) the Infographic Way