Module 15 2022

20/05/2022

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

Module 15 Lecture 8

The Organisation for Professionals in Regulatory Affairs

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ISO 14155:2020 Annexes

• Annex A (normative) Clinical Investigation Plan (CIP)

• Annex B (normative) Investigator's Brochure (IB)

• Annex C (informative) Case Report Forms (CRFs)

• Annex D (normative) Clinical Investigation Report

• Annex E (informative) Essential Clinical Investigation Documents

• Annex F (informative) Adverse Event Categorization

• Annex G (informative) EC responsibilities

• Annex H (informative) Application of ISO 14971 to clinical investigations

• Annex I (informative) Clinical development stages

• Annex J (informative) Clinical investigation audits

Module 15 Lecture 8

The Organisation for Professionals in Regulatory Affairs

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