The CTSC Clinical Trials Office provides regulatory knowledge and support to help ensure consistent standards and compliance with UC Davis policies, and state and federal regulations, throughout the clinical research life cycle.

Regulatory support services include:

  • Protocol development
  • Clinical trial consultation
  • IRB processes and documents
  • Conflict of Interest system
  • Corrective and Preventative Action plans (CAPA)
  • Single IRB process (reliance)
  • FDA applications (IND/IDE)
  • Regulatory quality assurance
  • Coverage analysis and budgets