Clinical Research Compliance Manual

For anyone receiving or applying for clinical research funding, Clinical Research Compliance Manual: An Administrative Guide covers today's most crucial topics, including:

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!