Clinical Research Compliance Manual: An Administrative Guide
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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
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