ICH GCP E6 (R3) Annex 2 - link to the full text
Annexe 2 covers designs such as pragmatic clinical trials and decentralised 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.
Following the end of the public consultation, the Annex 2 is expected to be finalised later in 2025.