EMA/ICH – Draft ICH E6(R3) guideline for good clinical practice – Annex 2 – Step 2b
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. This Annex should not be read as an endorsement of any specific trial design elements or data16 sources and should be read in conjunction with the Principles and Annex 1.
The consultation deadline is 28 February 2025.
More information on the ICH E3 guideline and on other public consultations carried out by the EMA on its Website.
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vroby (11 décembre 2024). EMA/ICH – Draft ICH E6(R3) guideline for good clinical practice – Annex 2 – Step 2b. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/12wcd





