EMA – Publication of the Overview of comments received on ICH E6(R3) guideline for good clinical practice – Annex 2 – Step 2b
Between 29 November 2024 and 28 February 2025, the EMA launched a public consultation on the Annex 2 of the ICH E6(R3) guideline for good clinical practice. The overview of the results of the consultation are now available on the EMA Website.
The Annex 2 covers designs such as pragmatic clinical trials and decentralized clinical trials, as well as those trials that incorporate real world data sources. The goal of Annex 2 is to offer GCP considerations for clinical trials with various design elements and data sources, ensuring that they are fit for their intended purpose.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (25 juillet 2025). EMA – Publication of the Overview of comments received on ICH E6(R3) guideline for good clinical practice – Annex 2 – Step 2b. ELSIBI. Consulté le 15 mars 2026 à l’adresse https://doi.org/10.58079/14fmk





