Module 15 Presentations

10/04/2024

Clinical Investigation Report

Contents: General – design, conduct, stats analysis and results. Cover Page – title, sponsors details, device details, Table of Contents

Summary – title, intro, purpose, conclusions, initiation date. Introduction – brief statement regarding the clinical investigation. Investigation Device and Methods. Clinical Investigation Plan – Summary of the CIP.

The Organisation for Professionals in Regulatory Affairs

37

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

38