The initiative aims to support the modernisation of good clinical practice in order to align with the increasingly diverse range of clinical trial types and data sources.
This will support the implementation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline.
Open consultation on ICH E6(R3) Annex 2
The public consultation for the draft ICH E6 (R3) Annex 2 is now open. This guidance on Good Clinical Practice (GCP) sets international standards for clinical trials involving human subjects.
Annex 2 addresses GCP considerations for trials with decentralised elements, pragmatic elements, and real-world data. It should be read along with the ICH E6 (R3) Principles and Annex 1.
Stakeholders can provide their feedback by 28 February 2025.
