Financial Administration of Clinical Trials Services
The Financial Administration of Clinical Trials Services (FACTS) office is the center for coordinating the financial aspect of your clinical trials.
FACTS offers a range of services that assist investigators and research personnel with the pre-award submission process and the post-award management of industry funded clinical trials. These services include:
- Negotiation and execution of Clinical Trial Agreements (CTA) and Confidential Disclosure Agreements (CDA)
- Assistance with budget preparation and cost analysis (MCA)
- Preparation of sub-agreements for multi-center clinical trials
- Submission of CMS letters for device trials
- Monitoring of clinical trial fund accounts
- Approval of financial transactions, including fund close-out
- Ensure payment for Registry studies represents fair market value
Rules for federal and private payors govern the conditions under which clinical services, items, and tests associated with a research study can be billed to study subjects or their insurers. The complexity of these rules and established procedures requires that FACTS reviews all clinical trials. FACTS assures that all related documents for the study are consistent.
FACTS will evaluate the project budget to determine if reimbursement covers the costs of the study requirements and that the budget includes upfront costs such as administrative start up, pharmacy and PPHS fees, PI and CRC time and effort and/or oversight, and overhead.
For Cancer Trials:
Research Financial Manager
For Cardiovascular, Surgery and/or Device Trials:
Research Finance Manager
Kelly Ann Ware
Director, Research Administration Systems