Princeton University Library Catalog

Clinical trials and human research : a practical guide to regulatory compliance / Fay A. Rozovsky, Rodney K. Adams.

Author:
Rozovsky, F. A. (Fay Adrienne), 1950- [Browse]
Format:
Book
Language:
English
Published/​Created:
San Francisco : Jossey-Bass, 2003.
Εdition:
1st ed.
Description:
xi, 639 p. : charts ; 27 cm.
Summary note:
"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."--BOOK JACKET.
Bibliographic references:
Includes bibliographical references and index.
Contents:
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, Accreditation, and Risk Management in Clinical Trials -- Ch. 16. Corporate Compliance and Human Research -- Ch. 17. Ethics in Human Research -- Ch. 18. International Research.
Subject(s):
ISBN:
0787965707
LCCN:
2003040074
OCLC:
51722748
Related name:
RCP:
C - S