ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the rights, safety and wellbeing of the trial subjects are protected. Ensure the credibility of clinical trial data.

TABLE OF CONTENTS

INTRODUCTION TO ICH GCP

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