GCP Training Update
ICH GCP E6(R3) Training Requirements for Investigators
Summary of the joint information from Swissmedic and swissethics, published 21 December 2025.
Principal Investigators holding GCP E6(R2)
- Must undertake and document a self-study of the revised ICH GCP E6(R3) guideline.
- Self-study training material is available on ICH.org under Efficacy Guidelines → E6(R3) Presentation & Training.
- Investigators who already hold a GCP E6(R3) or refresher GCP E6(R3) certificate are exempt from the self-study.
GCP E6(R3) Refresher Course Deadline
- Once Annex II of ICH GCP E6(R3) is finalised (expected January 2026), all principal investigators with a GCP E6(R2) certificate must complete a GCP E6(R3) refresher course within one year of Annex II coming into force in Switzerland.
- At a minimum, investigators must register for a swissethics-recognised course within that one-year timeframe.
- The list of recognised refresher courses is published on swissethics.ch under Training → GCP Courses.
Documentation & Ethics Committees
- Principal investigators in approved trials are not required to inform the ethics committees or submit GCP certificates.
- Training must be documented in the training logs / CVs at the research site.
Recommendation for Site Staff
- Swissmedic and swissethics recommend that site staff also complete a GCP refresher course within one year of Annex II coming into force.
- Site staff should not send GCP certificates to the ethics committees — training should be documented in the training logs / CVs at the research site.
Key takeaway: The transition from GCP E6(R2) to E6(R3) is mandatory for principal investigators and recommended for all site staff. The clock starts once Annex II comes into force in Switzerland.
Official source and additional information
Original publication — swissethics.ch (21.12.2025)ICH GCP E6(R3) guideline, presentations & training material — ich.orgRecognised GCP refresher courses — swissethics.chSwissmedic — Swiss Agency for Therapeutic Products
This summary is based on the joint information published by Swissmedic and swissethics on 21.12.2025. It is provided for convenience only and does not constitute official guidance.