Staff in OCTR will negotiate all clinical trial budgets to be opened at UConn Health for industry-sponsored, industry-supported, university-to-university, co-operative group- or foundation-supported clinical trials. Budgets for federal award or awards in response to a public solicitation may also be done to provide the investigator with a budget for his or her proposal.
Once a Budget Workbook is completed, the OCTR staff will conduct a comparison to the budget offered by the sponsor and communicate directly with the sponsor’s representative to ensure that the cost of all procedures is covered. Research budgets are negotiated based on Routine Clinical Care Costs (RC) and Protocol Induced Costs (PIC) published in the UConn Health charge master and salaries of the research personnel working on the clinical trial/research.
In addition, payment of adequate overhead costs, as well as, time and effort (T&E) for all study personnel will be negotiated. Further, it is the goal of the OCTR to make certain that initial trial start-up costs as well as study close- out fees are reimbursed by the sponsor.
In the event that the final negotiated budget is projected to result in a deficit, the PI has four options:
- A PI’s Banner Fund account will be identified that has funds which may be used to cover any shortfall. The account number must be provided for inclusion in the final Budget Workbook memo.
- The PI may petition his or her department chair for funds necessary to cover a projected shortfall. The account number must be provided for inclusion in the final Budget Workbook memo.
- The PI may petition his or her department chair to allow cost sharing of the PI and study coordinator T&E on the study. A memo from the department chair must be provided.
- The PI decides not to open the clinical trial at UConn Health.