This online course provides a practical and accessible overview of the final ICH E6(R3) Annex 2 Guideline, adopted on 03 June 2026. You will learn what additional considerations have been introduced for modern clinical trial designs, why these expansions matter, and how they impact participant safety, data integrity, informed consent and investigational product management across a wider range of trial settings.
Through clear explanations and real-world application, the course highlights key responsibilities for investigators, sponsors, and ethics committees when implementing decentralised elements, pragmatic approaches, digital health technologies (DHTs), real-world data (RWD), and external service providers. By the end of the course, you will understand how to apply Annex 2 requirements to your processes and oversight responsibilities to ensure compliance while supporting reliable trial results.
This course is designed to provide an understanding of the new considerations introduced in the ICH E6(R3) Annex 2 Guideline; it does not constitute a formal qualification. A valid, accredited GCP certificate is still required for anyone conducting clinical trial activities.
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