University of Florida requires all clinical research be conducted in compliance with applicable State and Federal regulations, and UF policies. It is critical that a budget be developed that details all costs associated with conducting the study in order for the Principal Investigator and University of Florida to be in compliance with regulatory requirements and act in a fiscally responsible manner.
There many different types of budgets that may be associated with a UF clinical research study. Some examples include:
- Grant Proposal Budget
- Sponsor Budget
- Detailed Budget
What is a Detailed Budget?
- A detailed budget lists all the services and activities necessary for conducting the study and the cost of each service/activity to be paid by the study.
- A detailed budget will help ensure that the Principal Investigator and the University of Florida are reimbursed sufficiently and will assist in defining the scope of work anticipated.
Steps in Developing a Detailed Budget
Perform Coverage Analysis
- The first step in developing a detailed budget is to perform a Coverage Analysis to determine who will pay for the costs of conducting the study.
- These costs may include study start-up costs, PI and study staff time and effort for study oversight and management, clinical services, supplies, and other expenses.
- At UF, the Coverage Analaysis is performed by the OCR CAB team .
- Prices for study-funded clinical services are obtained from the Procedure Coding Request (PCR) process, which can be performed either by the study team or by the OCR CAB team.
Draft the Budget
- Secondly, the details are documented in a draft budget format.
- The draft budget can be documented using a sponsor’s budget template, a UF internal budget template (see example), and/or entered directly into OnCore by the OCR CAB team.
Negotiate the Budget
- For studies where the budget is negotiable (e.g. Industry-sponsored clincial trials), either the study team or the OCR CAB team can negotiate the sponsor budget.
- For more information, see Negotiation Tips and UF Standard Fees (Gatorlink login required).
- UF has several standardized Fee Justification Letters that you can provide sponsors if they are questioning the purpose of these fees.
Review and Finalize the Budget
- Once the budget is negotiated and reviewed (as applicable), it will be finalized.
- For studies involving a contract with the sponsor, the final budget will be included as an attachment by the OCR Contracting team.
- For most OnCore studies, the final budget is also entered into OnCore.
- This OnCore budget is built by OCR staff and is the foundation of the Financials activity in OnCore, which includes creating sponsor invoices and reconciling sponsor payments (as applicable).