South African Good Clinical Practice Guidelines

Second Edition

Suggested Citation: Department of Health, 2006. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Department of Health: Pretoria, South Africa.

2006 Department of Health

All files are in PDF Format

Contents

Part 1

• Preamble
• Acknowledgements
• Contents

Part 2

1. Introduction
2. Protection of Study Participants
3. Responsibility of the Principal Investigator (PI) and Participating Investigators

Part 3

4. Responsibilities of the Sponsor
5. Quality Assurance
6. Data Management and Statistics
7. Multi-Centred Studies
8. Research Ethics Committees

Part 4

• References
• Recommended Readings
• APPENDIX A: ICH Guidelines for Good Clinical Practice; Declaration of Helsinki
• APPENDIX B: Clinical Trial Protocol and Protocol Amendment(s)
• APPENDIX C: Details of an Inspection by the National Regulatory Authority
• APPENDIX D: National Regulatory Authority Clinical Trial Evaluation Check-List (Draft)
• APPENDIX E: Disclosure of Conflict of Interest
• APPENDIX F: Glossary
• Writing Team
• Revising Team
• Contact Details for Comments and Copies