ICH E8

ICH E8 Section 7 – Considerations in Identifying Critical to Quality Factors

ICH E8 Section 7 details Critical-To-Quality factors, which are foundational considerations in designing and conducting safe and successful clinical trials. By exploring the best practices outlined in this course, learners will have an increased understanding of how sponsors, researchers, and participants can work collaboratively to ensure the accuracy, and scientific validity of clinical research.

CEU Credits: 0.1

Course Code: ELM-942

Duration: 20 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Effective Date: 05/31/2024

Curriculum for this course

Welcome

Critical- to-Quality Factors

CtQ Categories

Study Design CtQs

Non-Clinical Trials

Clear Endpoints

Control Groups

Feasibility

Study Population and Endpoints

Inclusion Criteria

Bias

Training

Participant Protection CtQs

Data Management CtQs

CtQ Chat

Monitoring and Reporting CtQs

Conclusion

The Roadmap

Test your Knowledge!

Revision History

v1.0 Course released on 02/25/2025

Author

Nick Cohen

GxP Quality Assurance Expert

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