BooksRock.com - Kids Books At Amazing Low Prices!

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