ICH E6(R3) Annex 2 Draft Guideline Released

The Draft ICH E6(R3) Annex 2 Guideline on Good Clinical Practice (GCP) reached Step 2a/b and was endorsed by the ICH Assembly. The Annex addresses GCP considerations that arise from the increased use of a wider range of design elements and data sources. Moreover, the document focuses on examples of trials that incorporate decentralized & pragmatic elements and/or Real-World Data (RWD).

ICH E6(R3) Guideline, Annex 1 and Annex 2

The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs. In addition, the document will provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. More information may also be found in the ICH Reflection Paper on “GCP Renovation”.

The ICH E6(R3) Guideline has been fully restructured and will be composed of an overarching principles and objectives document, Annex 1 (interventional clinical trials), Annex 2 (additional considerations for non-traditional interventional clinical trials), Glossary and Appendices. 

For more information please visit the ICH Efficacy Guidelines website.