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Clinical Trials and Human Research
A Practical Guide to Regulatory Compliance
Fay A. Rozovsky (Author), Rodney K. Adams (Author)
9780787965709, Wiley
Hardback, published 11 June 2003
656 pages
26 x 18.4 x 3.7 cm, 1.323 kg
"Ideal for anyone who wants a comprehensive understanding of clinical research…" (Journal of Clinical Research Best Practices)
This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
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
Subject Areas: Medicine: general issues [MB]
