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: 21/04/2023

Curriculum for this course

Welcome

Course Introduction

13 secs

What You'll Learn

18 secs

Overview of Sponsor Roles and Responsibilities

Sponsor Overview

51 secs

Sponsor- Investigator

32 secs

Sponsor Business Unites

35 secs

Quality Management

Quality Management

1 min 13 secs

Risk Areas

9 secs

Knowledge Check

5 secs

Quality Control

Roles and CRO's

1 min 17 secs

Quality Control and Assurance

1 min 59 secs

Sponsor QC Support

5 min 4 secs

Clinical Trial Quality Oversight and Regulatory Requirements

Clinical Trial Quality Oversight

1 min 35 secs

Monitoring

3 min 46 secs

Regulatory Requirements

2 min 2 secs

Conclusion

Conclusion

39 secs

What We Covered

30 secs

Test Your Knowledge

Results

Revision History

Author

Nick Cohen

GxP Quality Assurance Expert

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.