The purpose of the Research Financial Compliance Monitoring Program is to provide for continuous monitoring of financial compliance within all clinical research and clinical trials involving human subjects conducted within UConn Health, and to institute an audit plan that identifies and collects information necessary to support the UConn Health research compliance monitoring and audit activities.
The objective of the Research Financial Compliance Monitoring Program is to provide UConn Health investigators with:
- An internal mechanism for quality assurance, quality improvement and education pursuant to research financial/billing compliance and clinical research or clinical trials with human subjects.
- Practical support in the process of designing clinical trials budgets, assigning Protocol Induced Costs (PIC) and Routine Clinical Services (RC), identifying and complying with institutional policies as well as state and federal regulations and laws.
Selection of Studies
Most studies chosen for a compliance/billing audit will be clinical trials identified through a random process. There will be a focus on:
- Studies that combine both RC and PIC
- Investigator-initiated studies