This online course provides a practical and accessible overview of the transition from ICH GCP E6(R2) to ICH E6(R3). You will learn what has changed in the updated Good Clinical Practice guideline, why these changes matter, and how they impact the design, conduct, oversight, and documentation of clinical trials.
Through clear explanations and real-world application, the course highlights key differences in terminology, risk-based quality management, monitoring expectations, data governance, participant protection, and modern trial approaches such as decentralised and digital methods. By the end of the course, you will understand how to adapt your processes, documentation, and oversight responsibilities to ensure compliance with the new R3 requirements.
This course is designed to provide an understanding of the key differences between ICH GCP E6(R2) and ICH GCP E6(R3); it does not constitute a formal qualification. A valid, accredited GCP certificate is still required for anyone conducting clinical trial activities.
If this course isn’t right for you, take a look at our other online clinical courses.
