Good Clinical Practices (cGCP)

ICH E8 Section 6 – Conduct, Safety, Monitoring and Reporting

This course delves into the guidelines outlined in ICH E8, Section 6, which informs researchers on how to conduct ethical and rigorous clinical trials. The importance of balancing the collection of high-quality data with participant safety will help researchers ensure the integrity of their findings and protect the well-being of those involved.

CEU Credits: 0.1

Course Code: ELM-941

Duration: 15 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: v1.0

Effective Date: 05/17/2024

Curriculum for this course

Welcome

Building the House

Conducting the Study

Study Conduct and Quality by Design

Protocol Adherence

Training

Participant Safety

Conducting a Safe Study

Safety Monitoring

Withdrawal Criteria

Data Monitoring Committee

Study Reporting

Data Management

Maintaining Data Quality

Access to Interim Data

Informing Participants

Conclusion

A Well-Built House

Test Your Knowledge

Revision History

v1.0 - Course released on 01/28/2025

Author

Nick Cohen

GxP Quality Assurance Expert

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