Table of Contents

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Ethical considerations
5 Clinical investigation planning
6 Clinical investigation conduct
7 Suspension, termination and close-out of the clinical
  investigation
8 Responsibilities of the sponsor
9 Responsibilities of the principal investigator
Annex A (normative) - Clinical investigation plan (CIP)
Annex B (normative) - Investigator's brochure (IB)
Annex C (informative) - Case report forms (CRFs)
Annex D (informative) - Clinical investigation report
Annex E (informative) - Essential clinical investigation
        documents
Annex F (informative) - Adverse event categorization
Bibliography

Abstract

This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 194