Module 15 2022

20/05/2022

Annex J: Clinical investigation audits

CA’s will have the authority to conduct audits of the Clinical Investigation

Sponsor An audit of a sponsor’s organization and documents is intended to evaluate compliance with the sponsor’s own procedures, this document, and where appropriate, national regulations. Investigation Site An audit of the investigation site is intended to evaluate compliance with applicable agreements, sponsor procedures, EC requirements, the CIP, the requirements of this document, and where appropriate, national regulations.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

29

Safety Reporting – Key Documents

MDR Article 80 MDCG 2020-10 (1&2) ISO14155:2020 Annex F

Module 15 Lecture 8

The Organisation for Professionals in Regulatory Affairs

30

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