Module 15 2022

20/05/2022

Clinical Investigation Report

Contents: Results – data, safety events, compliance to the CIP Discussion and Conclusions – including the safety and performance data Ethics Investigators and Admin structure of the Clinical Investigation Signature Page Annexes

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

39

Clinical strategy notification requirements.

The role of the clinical team and regulatory governance

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

40

20