GUIDELINES FOR GOOD PRACTICE IN THE CONDUCT OF CLINICAL TRIALS IN HUMAN PARTICIPANTS IN SOUTH AFRICA

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CONTENTS

Preamble
Acknowledgements

  1. Introduction
  2. Protection of Study Participants
  3. Responsibility of the Principal Investigator & Participating Investigators
  4. Responsibilities of the Sponsor
  5. Quality Assurance
  6. Data Management and Statistics
  7. Multi-centred Studies
  8. Ethics Committees
  9. Ethical Consideration For HIV/AIDS Clinical and Epidemiological Research

References and Recommended Readings

Appendix A: ICH Guidelines for GCP; Declaration of Helsinki
Appendix B: Clinical Trial Protocol & Protocol Amendments
Appendix C: Details of a MCC inspection
Appendix D: Draft MCC Clinical Trial Evaluation Checklist
Appendix E: Disclosure of Conflict of Interest
Appendix F: Glossary

Writing Team: Ethical Guidelines for HIV Research
Additional Contributors: Clinical Trials Guidelines
Writing Team: Clinical Trials Guidelines