Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections
Drugs Medical audit Clinical Trials as Topic Guideline Adherence Management Audit Quality Control e-böcker
Wiley
2010
EISBN 9780470572740
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.
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.
