Good Clinical Practice

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.

ICH GCP (E6): TABLE OF CONTENTS

INTRODUCTION TO ICH GCP ICH GCP

1. GLOSSARY ICH GCP

2. THE PRINCIPLES OF ICH GCP ICH GCP

3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) ICH GCP

4. INVESTIGATOR ICH GCP

5. SPONSOR ICH GCP

6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) ICH GCP

7. INVESTIGATOR’S BROCHURE ICH GCP

8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL


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