Clinical Research Compliance Manual: An Administrative Guide

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Essential guidance on the laws and regulations affecting clinical research and trials.

An indispensable compilation of expert advice for any organization or individual conducting clinical research studies, the Clinical Research Compliance Manual: An Administrative Guide covers today’s most crucial topics. From human subject protections and institutional review board regulations to conflicts of interest, scientific misconduct and reimbursement issues, this definitive guide helps you establish best practices to execute administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent policies and legal developments.

All information is from leading experts and delivered in easy-to-understand language ideal for the medical research beginner and veteran alike.

The Clinical Research Compliance Manual provides the answers to the following questions and more:

What are my legal and ethical responsibilities regarding protecting human subjects in the provision of clinical research studies?
Which federal agencies/what regulations are most important to me in providing clinical research services?
How can I be assured that my organization will be paid appropriately for providing these services?
What are the regulatory requirements for reporting adverse events and whose responsibilities are they?
What is the role and responsibility of my Independent Review Board?
What actions can I take to increase my assurance that, in providing clinical research studies, we are NOT at risk for violating federal/state regulations?
What are the main issues associated with managing and accounting for federally funded clinical research?
What are the intellectual property issues associated with federally funded research?

Topics Include:

Human subject protections
Institutional Review Board regulations and requirements
Conflicts of interest
Scientific misconduct
Accounting for and managing federal grant money
Reimbursement issues
Intellectual property associated with drug development
Internal Auditing of the Revenue Cycle
Analysis of Gainsharing in OIG Advisory Opinions 05-1 to 05-6 and Other Recent OIG and CMS Guidance
What Does Compliance Have to Do with Quality?

Part of the Health Law & Compliance Integrated Library, the Clinical Research Compliance Manual: An Administrative Guide links to the primary source material in the CCH Health Care Compliance Reporter. The Library combines the latest information regarding Health Law from CCH and Aspen Publishers.

About The Author

Editor Patricia L. Brent, J.D., M.P.H. Ms. Brent 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.