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Clinical Research Compliance Manual: An Administrative Guide

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.. CCH and Aspen Publishers have joined together to offer you access to all the latest information regarding Health Law. Customers have the added advantage of having Aspen’s treatise materials in an electronic format that links to primary source material in the CCH Health Care Compliance Reporter. This title is part of the Health Law & Compliance Integrated Library. The Clinical Research Compliance Manual provides the answers to the following questions and more:

Benefits and Features

Provides clear and concise answers to many of your most critical questions, including:

• 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 IRB?
• 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?

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.

Topics Covered

• 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?