Clinical Research Compliance Manual: An Administrative Guide

• Human subject protections
• Institutional Review Board regulations and requirements
• Conflicts of interest
• Scientific misconduct
• Reimbursement issues
• And much more

Clinical Research Compliance Manual helps you establish best practices and carry out all administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent developments:

• Covers the major clinical research issues - with chapters written by experts in the field
• Provides legal explanations of the major regulatory issues in an easy-to-understand format
• Includes summaries of federal regulatory agencies, analysis of major cases, flow-charts, checklists, and footnotes to in compliance program development, auditing and monitoring

Clinical Research Compliance Manual has been updated to include:

• A new chapter on "Protecting Research Materials, Research Results, and Inventions: A University's Perspective"
• A new section on "Recent Proposed Changes to the Common Rule"
• Updated discussion of federal-wide assurance (FWA)
• OHRP's revision of its FAQs to be consistent with its Final Guidance on Engagement of Institutions in Human Subject Research
• Recent OHRP guidance on when institutions are not engaged in human subject research
• And much more