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.