Good Clinical Practices (cGCP)

ICH E8 Objectives, Fundamentals, and General Principles

This course provides a foundational understanding of the International Council for Harmonisation (ICH) E8 guideline, “General Considerations for Clinical Studies.”  By understanding the principles presented in this course, you can contribute to studies that are well-designed, produce reliable data, and ultimately ensure the safety and well-being of research participants.

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CEU Credits: 0.1
Course Code: ELM-927
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 04/18/2024

Curriculum for this course

Course Introduction
Objectives
Organization
Key Principles
Specifc Participant Protections
A Short History of Patient Protections: Origins
A Short History of Patient Protections: Effects
Knowledge Check
The Law and Ethics
Designing for Quality
Designing for Science
Involving Patients

Conclusion

Summary

Test Your Knowledge

Revision History

Author

Nick Cohen

GxP Quality Assurance Expert

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