Important information for clinical trial sites on updated ICH-GCP E6 guideline

Update: 21-May-2025

The ICH-GCP E6 guideline has been updated and will enter into force as Release 3 (R3) in the EU region on July 25, 2025, with Switzerland following suit.

According to the latest information from the AKEK central office, the Working Group on Investigator Training of the Association of Medical Ethics Committees (AKEK) and the German Medical Association (BÄK) does not consider it necessary for members of an investigator team/group to provide proof of participation in a formal update course on ICH-GCP E6 (R3) and will not provide a curriculum in this regard. 

However, all courses should be conducted on the basis of the current guidelines. Regardless of this, the curricula are currently being revised and are expected to be published in July 2025.

 

You will be able to find information on this topic later here:  https://www.akek.de/curriculare-fortbildungen/