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Clinical Trial Review and Setup

This Instructional Guide will serve to assist UF Research staff with expectations on review, routing and set up of Clinical Trials (CTs) given that they may be executed by DSP-Gainesville (DSP), DSP-Jacksonville (JAX) or the UF Office of Clinical Research (OCR).

UFIRST Proposal

  1. 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.
  2. 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.

UFIRST Agreement

  1. 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. Data Use Agreements (DUA) route to OCR. OCR will handle any DUA involving HIPAA- defined personally identified health information will be shared (i.e. a HIPAA-limited dataset). Any DUA for JAX will be reassigned to JAX. Other types of data agreements will be assigned back to DSP-Gainesville.
    3. Any agreement that indicates Yes to Human Subjects and then a response other than “None of the above” on the Agreement SmartForm P4.0 Human Subjects 0 route to OCR.
    4. All else route to DSP.
      1. 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.
    5. After approval by the DSP, JAX and OCR directors of the affected offices, agreements can be rerouted or assigned to a different office.
  2. 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.
  3. If OCR or JAX fully executes the agreement and it requires to be managed in funds 201 or 209, OCR or JAX (as appropriate) will create the UFIRST AWD shell and leave in draft state. DSP will pick up from draft and facilitate the rest of the award setup.
  4. If DSP fully executes the agreement, the Document Negotiator will create the UFIRST AWD shell and leave in draft state. DSP awards will pick up from draft and facilitate the rest of the award setup.
  5. If the award will be managed in fund 214, OCR and JAX have internal processes to notify the appropriate team members within their offices and set up the UFIRST Fund 214 project.

UFIRST Award

  1. 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.
  2. 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.
  3. 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.
  4. Special attention will be paid to carryover requirements when reviewing federal CTs.

UFIRST Award Modification

The original negotiating office will review and execute any amendments.

  1. Campus users can be pointed to the DSP – OCR flowchart on the DSP website should they have any questions about the agreement routing process.
    1. If DSP initially executed the agreement, DSP Award Team staff will engage the contract negotiator in cases where an amendment does more than simply add funds originally budgeted or anticipated or extend the time.
    2. If OCR initially executed the agreement, amendments will be submitted directly to OCR via the OCR Intake Process.
    3. If the Unit does not know who to contact, DSP will review and facilitate support to get the campus user to the appropriate office.
  2. While any modification is pending review of the negotiating office, the DSP Awards team will add a note to the history record of the UFIRST MOD, and the MOD should remain in Pending Responsible Unit Edits state.
  3. For 201/209 per case projects, if only depositing funding for an event or case under the original award, an additional UFIRST proposal or PRO revision is not required. This type of financial increase can be added to “Other Expenses” on the budget reconciliation page and does not need to match a sponsor baseline.

UFIRST Subaward Procedure

All new subawards are requested by campus through the Awards Module in UFIRST. Subawards requested for Awards in fund 201 and 209 will automatically route to DSP in UFIRST. Subawards requested for awards in fund 214 will automatically route to OCR. After approval by the DSP and OCR directors, subawards can be rerouted or assigned to a different office.

Subaward Entity Risk Assessment

The University of Florida Subrecipient Risk Assessment Policy states, “The Federal Uniform Guidance (2 CFR 200.331b) requires all recipients of federal funds to “evaluate each subrecipient’s risk of noncompliance with Federal statutes, regulations, and the terms and conditions of the subaward for purposes of determining the appropriate subrecipient monitoring.” To comply with this requirement, the University will perform a risk assessment on all subrecipients receiving federal funds and subrecipients under non-federal sources of funds that are not fixed rate payments based on cases or events.

  1. The Entity Risk Assessment will be performed by DSP pursuant to the University of Florida’s Subaward Risk Assessment Directives and Procedures.
  2. When a Subaward or Subaward modification has been assigned to OCR, the OCR Contracting Officer must notify the DSP Outgoing Subaward Manager through the UFIRST record if:
    1. the Subrecipient will be receiving federal funds and an Entity Risk Assessment is needed as triggered by UFIRST; or
    2. the subaward is for an enrollment-based non-federal clinical trial and OCR believes the Entity Risk Assessment should be bypassed.

Subaward Project Risk Assessment

The Project Risk Assessment will be completed by the Office assigned to the Subaward.

Reference:

UF Commitment Guidance (https://www.fa.ufl.edu/wp-content/uploads/2020/06/Commitment-Guidance.pdf) Subaward Risk Assessment Policy (https://generalcounsel.ufl.edu/regulations-and-policies/)
Subaward Risk Assessment Directives and Procedures (https://generalcounsel.ufl.edu/regulations-and-policies/)