A must-have guide for any professional in the drug manufacturing industry. The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and instit.

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.