Clinical Research Compliance Manual by Lawrence W Vernaglia
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Clinical Research Compliance Manual

Clinical Research Compliance Manual


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About the Book

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, flowcharts, checklists, and footnotes to compliance program development, auditing and monitoring

Clinical Research Compliance Manual has been updated to include:

  • Discussion on the revised Common Rule
  • Analysis of enforcement of the May 25, 2018 GDPR
  • New information on HHS's updated informed consent in human subject research regulations commonly referred to as the "2018 Rules"
  • Updated sections on NIH Supported Clinical Research, including a discussion of recent changes made to the Bayh-Dole Act of 1980
  • Revised sections on the categorization of medical devices as it pertains to reimbursement

And much more!

Previous Edition: Clinical Research Compliance Manual: An Administrative Guide, Second Edition, ISBN 9781543806724


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Product Details
  • ISBN-13: 9781543817553
  • Publisher: Wolters Kluwer Law & Business
  • Publisher Imprint: Aspen Publishers
  • Language: English
  • Returnable: Y
  • ISBN-10: 1543817556
  • Publisher Date: 17 Nov 2019
  • Binding: Loose-leaf
  • No of Pages: 776


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Clinical Research Compliance Manual
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