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Clinical Research Compliance Manual: An Administrative Guide
Contributor(s): Brent, Patricia (Author), Vernaglia, Lawrence W. (Author)

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 ISBN: 0735569665     ISBN-13: 9780735569669
Publisher: Aspen Publishers
OUR PRICE: $649.95  

Binding Type: Loose Leaf - See All Available Formats & Editions
Published: March 2007
Qty:
Temporarily out of stock - Will ship within 2 to 5 weeks
Additional Information
BISAC Categories:
- Law | Health
- Medical | Research
- Medical | Clinical Medicine
Dewey: 344
Physical Information: 0.7" H x 8.3" W x 11.1" L (1.40 lbs) 588 pages
 
Descriptions, Reviews, Etc.
Publisher Description:
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

 
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