ICH-GCP E6(R3)

Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve human participants. The ICH E6 guideline is the reference that regulators, sponsors, sites and ethics committees around the world rely on. In 2023 the ICH agreed a fundamentally revised version, E6(R3), and this course teaches you what it says and, just as importantly, how to apply it.

E6(R3) is not a cosmetic update. It reorganises the guideline around a set of overarching principles and modular annexes, it puts quality by design and risk-based thinking at the centre, and it deliberately makes room for the diversity of modern trials: decentralised elements, real-world and electronic data sources, and a wide range of enabling technologies. If you learned GCP from the older E6(R2), this course shows you exactly what changed and why.

By the end you will understand the structure and principles of E6(R3), be able to identify factors critical to quality and apply proportionate effort, describe the modernised responsibilities of sponsors and investigators, and confidently discuss risk-based monitoring, data governance, decentralised trial elements and informed consent in a contemporary setting. Every module ends with a short quiz and the course closes with a ten-question final exam leading to your certificate.