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Research Compliance Professional’s Handbook, 3rd Edition


Conducting research by the rules 

In the highly regulated world of clinical research, the role of the compliance professional is vital to maintain compliance with a wide range of government entities. With this practical guide, you’ll learn how to build and maintain a clinical research compliance and ethics program.

Key areas covered in this book are: 
  • Human subject protections
  • Biosecurity and biosafety 
  • Research using animals 
  • Scientific misconduct 
  • Conflicts of interest 
  • Privacy and security 
  • Records management 
  • Data and safety monitoring 
  • Grant and trial accounting 
  • Effort reporting 
  • Clinical trial billing 
  • Role of oversight entities 
  • Auditing and monitoring 
  • Integrating research compliance into corporate compliance
About the authors

Written by more than 20 authors with hands-on experience in clinical research compliance.

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