The International Council for Harmonization (ICH) adopted Annex 2 to the Guideline on Good Clinical Practice (GCP) E6(R3) on June 3, 2026. The content of Annex 2 focuses on the collection of data from a notably wider range of sources for clinical trials, including decentralized and pragmatic trials.

Health Canada is one of four standing members of the ICH and is a signatory on the approval of the document.

The finalized version of Annex 2 does not include any major changes from the draft guideline issued in November 2024. However, there were several updates and clarifications.

What are five notable updates to the approved final version of E6(R3) Annex 2?

1. The first includes clarification on the definition of digital health tech technologies used to collect participant data for clinical trials.
2. It is now stated that informed consent can be obtained through a video call.
3. There is new information on the investigator oversight section. Essentially, there should be documented evidence of oversight.
4. The protocol and design section now includes a new statement that sponsors consider incorporating: trial-related activities that are part of usual clinical practice should be assessed to determine whether such an approach is fit for purpose for use in the trial and that it complies with applicable regulatory requirements.
5. In the section on real-world data considerations, new text has been added to indicate that the sponsor must ensure the fitness of purpose for the real world data.

Other notable updates

Canadian regulations for clinical trials timing announcement

On June 3, 2026, Health Canada announced that the new Canadian regulations pertaining to clinical trials would be released in the spring 2027, with intent of full implementation for spring 2028. Specific dates will be announced later.