Good Clinical Practice in Practice: Implementing ICH E6(R3)

ICH E6(R3) represents a major modernization of Good Clinical Practice since the original 1996 guideline, building on the risk-based and quality-focused principles introduced in E6(R2). It emphasizes a proportionate, risk-based approach to trial design and conduct incorporating Quality by Design and risk proportionality as foundational principles. The guideline expands expectations for data governance and clarifies sponsor and investigator responsibilities. However, guidelines alone do not drive change in practice; implementation depends on training and cross functional understanding.

As the ICH training partner selected to develop the ICH E6(R3) training curriculum, the MRCT Center, in collaboration with the ICH E6(R3) Expert Working Group, is producing a five-module course to translate the ICH document into actionable guidance for the people who run trials.



Clinical Trials Week honors trial participants and the workforce whose training and preparation shapes their care. In that spirit, join Sarah White and a panel of experts representing the US FDA and industry sponsors, who are also members of the E6(R3) Expert Working Group, to highlight the importance of implementing the E6R3 guideline correctly and discuss key areas of the E6(R3) guideline that may be challenging to implement. The session walks through a practical case example applying Risk Based Quality Management principles, including the identification of Critical to Quality factors and prioritization of key risks, and will explore implementation of ICH E6(R3) across key areas, such as data governance, sponsor and investigator responsibilities, and the incorporation of diverse perspectives in trial design and planning. The session will underscore the importance of all individuals performing clinical trial activities in understanding these critical study attributes and how their role contributes to safeguarding them and ensuring they are consistently protected through their day-to-day decisions and actions. It will also spotlight the available ICH E6(R3) training modules. Attendees will leave with an understanding of the foundational concepts in ICH E6(R3), how risk proportionate approaches can be applied to clinical trial design and conduct, and how to introduce and disseminate the training to their teams.

Expert Panel



Cheryl Grandinetti:

•  Associate Director for Clinical Policy, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, CDER, FDA
• FDA Topic Lead for ICH E6(R3)

David Nickerson

• Head of Clinical Quality Management, EMD Serono
• PhRMA Topic Lead for ICH E6(R3)

Rebecca Stanbrook

• Consultant, RESaltas GmbH
• EFPIA Topic Lead for ICH E6(R3)

Moderated by Sarah White, Executive Director, MRCT Center