ICH E6

ICH E6 (R3) IRB/IEC

This course uses a practical study scenario to illuminate the IRB/IEC’s core roles, including their structural requirements and how they operationalize their activities. Learn how this vital oversight, aligned with ICH E6 R3, ensures ethical conduct and protects participants from initial consent through trial completion, coordinating within a global safety network.

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CEU Credits: 0.1
Course Code: ELM-984
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 07/21/2025

Curriculum for this course

Course Introduction
The IRB/IEC
Submissions and Communication
Who is Reviewing Your Protocol?
IEC Members
Processes and Procedures
IEC Review
Initial Approval
Consent and Assent
Clinical Trial Compensation
6 Months Into the Trial
Ongoing Review
Protocol Deviations and Compliance
Record Keeping
An Ethical Success Story
Summary
Test Your Knowledge
v1.0 Course released on 09/30/2025

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