INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
TABLE OF CONTENTS
INTRODUCTION 
1. GLOSSARY
2. THE PRINCIPLES OF ICH GCP
3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
4. INVESTIGATOR
5. SPONSOR
6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
7. INVESTIGATOR’S BROCHURE
8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL