ICH E6

ICH E6 – Sponsor (Chapter 5) (R2)

Clinical trials can range from a relatively small operation to a massive undertaking. With all the moving pieces and integral parts of a trial, qualified and capable management is integral in order to be successful. That’s where a sponsor comes in. Per ICH E6 R2, a sponsor is “an individual, company, institution or organization that takes responsibility for the initiation, management and/or financing of a clinical trial.”

CEU Credits: 0.1
Course Code: ELM-914
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 04/21/2023

Curriculum for this course

Course Introduction
What You'll Learn
Sponsor Overview
Sponsor- Investigator
Sponsor Business Unites
Quality Management
Risk Areas
Knowledge Check
Roles and CRO's
Quality Control and Assurance
Sponsor QC Support
Clinical Trial Quality Oversight
Monitoring
Regulatory Requirements
Conclusion
What We Covered

Test Your Knowledge

Results

Revision History

Author

Nick Cohen

GxP Quality Assurance Expert

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