This new publication sets out the final version of the ICH E6(R3) Guideline - Annex 2 - June 2026

ICH E6(R3) Annex 2 provides additional GCP considerations, focusing on trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD). Clinical trials may incorporate one or more of these methodologies. Annex 2 is not meant to be comprehensive of all methodologies, recognising that clinical trial ecosystems may continue to evolve, and new approaches, designs and data types may emerge. Considerations included in this Annex may be applied to those evolving methodologies provided they are applied in accordance with local regulatory requirements. This Annex should not be read as an endorsement of any specific methodologies and should be read in conjunction with the Principles and Annex 1.

For the purposes of Annex 2, decentralised elements in a clinical trial are those trial-related activities conducted outside the investigator’s location. These may include trial visits and/or protocol-related procedures conducted at the trial participant’s home, local healthcare centres or mobile medical units. They also encompass remote interactions, such as video calls or the use of digital health technologies (DHTs) to conduct visits, perform procedures and collect data.

Size: A6 Pocketbook