Module 15 2022

20/05/2022

Adverse Event Categorisation – ISO14155

Flowchart F1 is only used if DD not associated to an AE

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

37

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

Module 15 Lecture 8

38

19