Swissmedic and swissethics expect that all principal investigators involved in the conduct of clinical trials who currently hold a GCP E6(R2) certificate undertake and document a self-study of the revised guideline ICH GCP E6(R3). Investigators who already have a GCP E6(R3) or a refresher GCP E6(R3) certificate do not have to take the self-study. Training material for a self-study is available here (ICH.org / efficacy guidelines / E6(R3) presentation & training).

In light of the expected finalisation of Annex II of the ICH GCP E6(R3) guideline in January 2026, it is also expected that all principal investigators involved in clinical trials who currently hold a GCP E6(R2) certificate will complete a GCP E6(R3) refresher course within one year of Annex II coming into force in Switzerland or, at a minimum, register for a swissethics recognized course within that timeframe. The list of recognized GCP E6(R3) refresher courses is published here (swissethics.ch / training / GCP-courses).

Principal investigators involved in approved clinical trials are not required to inform the ethics committees or submit the GCP certificates but must document their trainings in the training logs/CVs at the research site.

Swissmedic and swissethics recommend that site staff complete a GCP refresher course within one year of the revised ICH GCP E6 Annex II coming into force in Switzerland. The site staff should not send the GCP certificates to the ethics committees but document their training in the training logs/CVs at the research site.

Swissmedic and swissethics