ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2

This course is organized into four sections:

1. Introduction and IRB responsibilities
2. IRB Operations
3. IRB Procedures
4. IRB Records

Upon completion of this course, you will understand how to:

• Define “IRB.”
• Describe the structural requirements of an IRB.
• List the roles and responsibilities of an IRB.
• Discuss how an IRB operationalizes its activities.