Good Clinical Practices (cGCP)

Serious Breaches

A serious breach in a clinical trial is any deviation from regulatory, protocol, or procedural requirements that significantly impacts participant safety, rights, or the reliability and robustness of the trial data. In this course, learners will explore what constitutes a serious breach, global regulations, and reporting requirements. 

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CEU Credits: 0.1
Course Code: ELM-405
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.1
Effective Date: 09/13/2024

Curriculum for this course

Course Introduction
Definition of a Serious Breach
Other Important Vocabulary
Potential Serious Breach Issues
Critical and Non-Critical Issues
General Reporting Requirements
Agreements between Sponsors and Vendors
Initial Breach Reporting
Complex Issues
Follow-up Breach Reporting
More Details on Reporting
Examples That Are Not Serious
Examples That May Be Serious
Examples of Serious Breaches
Summary
Test Your Knowledge
v1.1 Minor update on 09/04/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.0 Course Released on 10/29/2024

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