Module 15 Presentations

10/04/2024

ISO14155

ISO14155:2020 Clinical investigation of medical devices for human subjects - Good Clinical Practice Published July 2020 Number of pages: 83 (39 pages main document 44 pages form the annexes: A-J, ZA-ZC)

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ISO 14155:2020 Contents

1. Scope

2. Normative References

3. Terms and Definitions

4. Summary of Good Clinical Practice (GCP) Principles

5. Ethical Considerations

6. Clinical Investigation Planning

7. Clinical Investigation Conduct

8. Suspension, Termination, and Close-out of the Clinical Investigation

9. Responsibilities of the Sponsor

10. Responsibilities of the Principal Investigator

The Organisation for Professionals in Regulatory Affairs

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