Clinical Research Compliance Manual from Aspen Shows How to Stay in Compliance and Protect Funding
(NEW YORK, N.Y., May 23, 2006) – Now from Aspen Publishers, part of the Wolters Kluwer Law & Business group, there is a comprehensive one-stop resource for any organization or individual conducting clinical research studies. The Clinical Research Compliance Manual: An Administrative Guide covers all issues relating to clinical research, from compliance through reimbursement, with expert guidance and time-saving features (www.aspenpublishers.com).
“Clinical trials and research can bolster an institution’s prestige and its finances, but these programs also have traps that can expose an institution to serious liability,” noted Patricia L. Brent, consulting editor for the Manual. “This book shows how to avoid the many potential pitfalls of clinical research programs.”
Clinical Research Compliance Manual: An Administrative Guide covers today’s most crucial topics, including, human subject protections; Institutional Review Board regulations and requirements; informed consent; grants administration; conflicts of interest; scientific misconduct; reimbursement issues; clinical practice standards; and intellectual property issues.
The Manual helps establish best practices to carry out all administrative tasks in a compliant manner while keeping readers completely up-to-date on the most recent developments. It covers the major clinical research issues with chapters written by experts in the field, while providing legal explanations of the major regulatory issues in an easy-to-understand format.
The Manual is filled with practical features such as charts to simplify the compliance process, tables to make crucial information available at a glance and in-depth footnotes to save research time and effort, making it a one-stop reference for clinical research compliance.
About the Editor and Contributors
Patricia L. Brent, JD, MPH, is president of Morgan Hill Associates, a consulting firm she founded in 1998. In addition to providing consultation on the development and maintenance of an effective compliance program, program implementation, policy development and staff and board education and training, she has first-hand experience working in clinical research at major academic centers. She is the author of several books, monographs and articles on Medicare reimbursement and compliance-related topics, including Understanding Reimbursement for Investigational Drugs and Devices, Inside Medicare Outliers: Keys to Policy, Payment and Compliance and Critical Access Hospitals: A Guide to the Application Process. She has spoken locally and regionally on compliance-related issues before various audiences.
Each of the 22 expert contributing authors brings many years’ experience to their writings and an impressive list of professional accomplishments. They include attorneys who represent large academic research institutions and counsel healthcare providers on the legal aspects of providing clinical research services, consultants who advise clients on the effectiveness of policies and procedures and professionals within healthcare organizations who must implement and monitor these policies.
Availability and Pricing
For more information or to order, call 1-800-638-8437* or visit www.aspenpublishers.com. Clinical Research Compliance Manual: An Administrative Guide is available as a single loose-leaf volume. The price for a one-year subscription is $329 and includes quarterly updating. Any new edition or supplement issued within three months of purchase of the main edition will be sent free of charge.
* This 800 number is toll-free in the United States only. Calls to this number from outside the United States will be charged at international rates.
About Wolters Kluwer Law & Business
Wolters Kluwer Law & Business is a leading provider of research products and software solutions in key specialty areas for legal and business professionals, as well as casebooks and study aids for law students. Its major product lines include Aspen Publishers, CCH, Kluwer Law International and Loislaw. Its markets include law firms, law schools, corporate counsel and professionals requiring legal and compliance information. Wolters Kluwer Law & Business, a unit of Wolters Kluwer, is based in New York City and Riverwoods, Ill.
Wolters Kluwer is a leading multinational publisher and information services company. The Company’s core markets are health, corporate services, financial services, tax, accounting, legal, regulation, and education. Wolters Kluwer has annual revenues (2005) of €3.4 billion, employs approximately 18,400 people worldwide and maintains operations across Europe, North America and Asia Pacific. Wolters Kluwer is headquartered in Amsterdam, the Netherlands. Its depositary receipts of shares are quoted on the Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices. For more information, see www.wolterskluwer.com.
Contact
Neil Allen
+1 847-267-2179
neil.allen@wolterskluwer.com
Leslie Bonacum
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