Clinical Trial Review and Setup

Information to assist with review, routing and set up of Clinical Trials (CTs).

What Clinical Trials require a UFIRST proposal? Those that will be managed in funds 201 or 209
1. Any funded study with federal or federal flow-through dollars
2. Any non-federal clinical trial where UF receives payment for reimbursed costs rather than fixed rate payments based on cases or events
3. For reference, cash-based funds do not require a proposal and will be housed in Fund 214, which is managed by OCR. If the study originates from JAX, the management is handled jointly by JAX and OCR.
Any clinical trial proposal required to route through UFIRST must follow normal proposal preparation standards.
1. If a full budget is not provided for the duration of the project, the budget should be routed based on startup costs + (anticipated enrollment * per patient reimbursement)
2. Federal CTs without a quantifiable effort commitment will have the 1% de minimis entered and tracked in the UFIRST Award module
3. An exception to the full budget requirement might be if the proposal is for a Clinical Trials Support Unit (CTSU) that has a funding sheet or other contracting arrangement from entities such as NRG, COG, and SWOG (as referenced here: https://www.cancer.gov/research/infrastructure/clinical-trials/nctn). In these situations the proposal would be routed with a $0 budget.

Agreements will route to the appropriate negotiating team based on the Type of Agreement on page 1.0 and Humans Subjects detailed questions on page 4.0 of the AGR SmartForm. In general:
1. Any agreement with department under the College of Medicine-Jacksonville department structure will be self-assigned by JAX from the DSP Unassigned worklist.
2. If the AGR will be managed in fund 201 or 209, financial contact information should reflect C&G and the Administrative Contact should be ufawards@ufl.edu.
Terms and Conditions should be fully reviewed by the entity who is responsible for reviewing the agreement. If a Purchase Order (PO) is generated after the original AGR is executed and the PO does not clearly indicate for billing purposes only, the DSP awards team will engage the original agreement negotiator to review the terms of the PO.
Any negotiator who executes an agreement should create the UFIRST AWD shell and leave in draft state. DSP will pick up from draft and facilitate the rest of the award setup.

Federal, budget-based CTs will be released according to the proposed budget.:
1. If there is not a full budget for the duration of the project but rather start up and enrollment-based costs, the UFIRST award allocation and budget reconciliation will be released according to startup costs plus anticipated enrollment for the first year of enrollment multiplied by the per case reimbursement. These costs should mirror that of the UFIRST proposal.
2. If a CT is being setup without a full budget, the budget reconciliation and sponsor authorized should be $0.00.
When federal CTs have a cost reimbursable component and a fixed milestone/per case or event invoicing component, two projects will be setup. The budget for the per patient invoicing project will be based on actual payments received. Finances for these CTs are handled by Contract and Grants.
Any nonfederal CTs that are cost-reimbursable, have budget restrictions, or involve a quantifiable effort commitment will be setup and released according to a-b above. Non-federal CTs where reimbursement is enrollment based with no general budgetary restrictions and no committed effort will be setup and managed by OCR in fund 214. In JAX, the 214 fund will be managed jointly by JAX and OCR. They require no UFIRST proposal.
Special attention will be paid to carryover requirements when reviewing federal CTs.