Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance (Hardcover)

Ch. 1. The evolution of human experimentation regulation

Ch. 2. Current federal regulations and agencies involved in human research

Ch. 3. State regulation of human research

Ch. 4. Selection and recruitment of research subjects

Ch. 5. Informed consent in clinical trials

Ch. 6. Confidentiality of clinical trials information

Ch. 7. The investigator

Ch. 8. Research protocols

Ch. 9. The institutional review board

Ch. 10. Patient safety in clinical trials research

Ch. 11. Human research under the Food, Drug & Cosmetic Act

Ch. 12. Behavior research

Ch. 13. Multisite and collaborative studies

Ch. 14. Medical malpractice liability in human research

Ch. 15. Quality improvement, accrediation, and risk management in clinical trials

Ch. 16. Corporate compliance and human research

Ch. 17. Ethics in human research

Ch. 18. International research