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Research Compliance Professional’s Handbook, 4th Edition

 

Conducting research by the rules 

The Research Compliance Professional’s Handbook is a practical guide to building and maintaining a clinical research compliance and ethics program. It is an essential text in the world of clinical research, where the role of the compliance professional is vital to maintain compliance with a wide range of government entities.

Key areas covered in this book are: 
  • Artificial intelligence - NEW!
  • 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

NEW! Chapter 16:  Artificial Intelligence Innovations in Healthcare: Identifying and Managing Emerging Compliance Risks
This chapter includes the definition of artificial intelligence, integration of AI into healthcare delivery, legal implications, managing compliance risks related to AI, and AI best practices for researchers.

  

  To learn more about this book, check out the following podcasts on the Compliance  Perspectives Podcast with Adam Turteltaub
Listen                                

   Kelly Willenberg on the Latest Edition of the Research Compliance Professional’s Handbook

About the authors

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

Copyright for Research Compliance Professional's Handbook, 4th Edition

Contributors for Research Compliance Professional's Handbook, 4th Edition

1 Research Compliance 101

2 Financial Conflicts of Interest in Research: Flexible Compliance with the PHS Final Rule

3 Scientific Integrity and Research Misconduct

4 Biosafety, Biosecurity, and Biorisk Management

5 The Regulation of Research Using Animals

6 The Regulation of Research with Human Subjects

7 FDA Regulation of Clinical Research

8 Research Privacy and Security: Myths, Facts, and Practical Approaches

9. Research Records Management

10 Data and Safety Monitoring

11 Clinical Research Billing Compliance

12 Grant Management

13 Research Auditing and Monitoring

14 What Are Export Controls?

15 Integrating Research Compliance into the Corporate Compliance Program

16 Artificial Intelligence Innovations in Healthcare: Identifying and Managing Emerging Compliance Risks

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