The document discusses ICH-GCP E6 guidelines related to clinical research regulations, focusing on ethical principles, risks vs benefits, and the rights and safety of participants. It includes key components such as the roles of institutional review boards, sponsors, and investigators, alongside essential documents for conducting clinical trials. Additionally, it emphasizes compliance, informed consent, confidentiality, and quality assurance in clinical research.

1. CLINICAL RESEARCH REGULATIONS
(MRA 103T)
TOPIC: ICH – GCP E6
(UNIT – IV)
MOHAMED FAZIL M
P1821003
M. Pharmacy – 1st Sem
Regulatory Affairs
MOB: 8870884215

2. INTEGRATED ADDENDUM TO ICH E6 (R1)
ICH – GCP GUIDELINES
E6 (R2)

3. TABLE OF CONTENTS
INTRODUCTION 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
7) INVESTIGATOR’S BROCHURE
8) ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

4. INTRODUCTION TO ICH GCP GUIDELINES

15. THE PRINCIPLES OF ICH GCP

19. ETHICAL PRINCIPLES

20. RISKS vs BENEFITS

21. RIGHTS, SAFETY, & WELL-BEING

22. CLINICAL INFORMATION

23. SCIENTIFIC PROTOCOL

24. COMPLIANCE WITH INSTITUTIONAL REVIEW BOARD (IRB)

25. RESPONSIBILITY

26. QUALIFIED PERSONNEL

27. INFORMED CONSENT

28. CLINICAL TRIAL DATA

29. CONFIDENTIALITY

30. INVESTIGATIONAL PRODUCTS

31. QUALITY ASSURANCE

32. INSTITUTIONAL REVIEW BOARD
OR
INDEPENDENT ETHICS COMMITEE