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Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance
Fay A. Rozovsky, JD, MPH,
Marsh Health Spectrum, Richmond, Virginia
Rodney K. Adams,
LeClair Ryan, Richmond Virginia
ISBN: 978-0-7879-6570-9
©2003
656 pages
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Description
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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.
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