Research Roadmap

Are you trained yet??

In January 2025, the R3 update of ICH GCP E6 was published and will be effective from 23 July 2025.

This ICH GCP update is applicable for all research staff involved in the conduct of clinical trials subject to the ICH GCP guidelines. Research staff with a valid eBROK license can complete the ICH GCP E6 (R3) training via the updated modules available on their eBROK platform. The self-training on ICH GCP E6 (R3) provided below is for all other research staff in addition to your existing eBROK and/or WMO/GCP certification.

For training requirements specific to Amsterdam UMC, please refer to: “Bijlage: Trainingseisen studieteamleden WMO-plichtig onderzoek” of the GCT T19 Site signature and delegation log - Amsterdam UMC (versie 3). ​

After completing the self-training, make sure to document it in your TMF/ISF. For example by using the template Individual training log or Study training log. Refer to or attach the self-training slides below as supporting documentation.

For more guidance and the full guideline, please refer to:​

• The IGJ recently published important considerations for study teams to prepare them for the new version of the ICH GCP E6 Guideline;
• The ACRP published a detailed overview of the changes between ICH GCP E6 (R2) and E6 (R3): ICH E6(R2) to ICH E6(R3) comparison_ACRP;
• The full guideline is available via the EWMA website: ICH E6 (R3) Guideline on Good Clinical Practice (GCP)_Step 5.​