EMA - The European Medicines Agency has published for public consultation the ICH Guideline for Good Clinical Practice E6(R3) Annex 2

11th December 2024

The European Medicines Agency has published for public consultation the ICH Guideline for Good Clinical Practice E6(R3) Annex 2.

Good Clinical Practice (GCP), as described in ICH E6(R3) Principles and Annex 1, is applicable across clinical trial types, designs and settings, and remains relevant when various operational approaches and data sources are used in a clinical trial. As clinical trial designs evolve and technological advances occur, the appropriate and proportionate application of GCP will support these approaches while safeguarding participants’ rights, safety and well-being, and helping to ensure the reliability of trial results. ICH E6(R3) Annex 2 addresses the GCP considerations that arise from the increased use of a wider range of design elements and data sources. Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD). Clinical trials may incorporate one or more of the design elements and data sources mentioned above. Annex 2 is not meant to be comprehensive of all design elements since clinical trial ecosystems may continue to evolve, and the operational approaches and data sources utilised may expand. However, considerations provided in this Annex may apply in accordance with local regulatory requirements. Annex 2 should not be read as an endorsement of any specific trial design elements or data sources and should be read in conjunction with the Principles and Annex 1.

Comments should be provided using this template and sent to ICHE6_R3@ema.europa.eu by 28 February 2025

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