Course Overview:

This course provides a thorough introduction to the revised ICH E6(R3) Good Clinical Practice Guideline, highlighting its shift toward a more flexible, risk-based, and technology-aware approach to clinical trial conduct. Learners will explore the key conceptual updates, including enhanced quality by design principles, expanded guidance on roles and responsibilities, and strengthened data governance requirements. Through a structured comparison with E6(R2), the course clarifies what has changed, why it matters, and how to practically implement the new principles in real-world trial settings.

Duration:
Approximately 60 minutes (self-paced)

Format:
Self-paced eLearning

Target Audience:
Clinical research professionals, sponsor staff, monitors, investigators, and trial site personnel who are already familiar with GCP principles under ICH E6(R2)

Prerequisites:
Working knowledge of ICH GCP E6(R2)

Certification:

Upon successful completion, learners can download a Certificate of Participation.

Learning Objectives:

By the end of this course, learners will be able to:

• Understand the structural differences between R2 and R3
• Describe the key updates introduced in ICH E6(R3)
• Assess the impact of changes on roles, responsibilities, and documentation
• Apply E6(R3) principles in risk-proportionate trial design and oversight
• Prepare for transitioning organizational SOPs and training to align with R3