INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

Administrator — Mon, 29 Sep 2008 13:14:43 +0000

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