Table of Contents

Good clinical practice and therapeutic product development.
Therapeutic products clinical development in the United States.
The inspection preparation.
Analysis of warning letters.
Fraud and misconduct in clinical research.
Appendix A: some answers to the most problematic questions in compliance.
Appendix B: guidance for industry--E6 good clinical practice: consolidated guidance.
Appendix C: World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects.
Appendix D: Nuremberg Code.
Appendix E: the Belmont report: ethical principles and guidelines for the protection of human subjects of research.