Understanding Clinical Trial Protocols Under ICH E6(R3) Guidelines

This interactive course offers a clear, practical approach to understanding and applying ICH E6(R3) principles in clinical trial protocol development and review.

Participants will learn how to incorporate Quality by Design (QbD), risk-based thinking, and feasibility assessment into protocol planning, ensuring compliance and transparency throughout the trial lifecycle. Through engaging content and case studies, the course emphasizes identifying critical protocol components, evaluating feasibility, and effectively communicating decisions to stakeholders.

Learners will gain access to practical tools—including a Protocol Components Worksheet, Research Design Models, a Feasibility Assessment Checklist, and a Case Study Guide—to reinforce best practices and support day-to-day application of ICH E6(R3) guidance.​

At the end of this course, participants should be able to:

• ​Apply ICH E6(R3) principles to design and review clinical trial protocols.
• ​Incorporate Quality by Design (QbD), risk‑based thinking, and feasibility assessment into protocol planning.
• Identify and structure critical protocol components using practical tools (e.g., Protocol Components Worksheet, Research Design Models).
• Ensure compliance and transparency throughout the trial lifecycle via clear documentation and rationale.
• Communicate protocol decisions effectively to stakeholders using fit‑for‑purpose strategies (e.g., amendment summaries, webinars, Q&A).​