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Closed / Withdrawn Prior to Activation

There are times when a clinical trial project is terminated before the research is initiated at the University. In some instances and irrespective of whether a clinical trial agreement has been executed, the sponsor will pay the University for certain start-up expenses, such as IRB fees. In these cases, the revenue received from the sponsor will be dispensed in accordance with the following guidelines:

Revenue $5,000 or Less
Revenue may be deposited to a designated account. No F&A costs will be taken from the funds.

Revenue More Than $5,000
Revenue must be deposited to a project account (R&A required, but not IRB approval). Department may spend out funds within 30 days or close out and transfer residual balance to existing gift account in accordance with close out procedures. Appropriate F&A costs will be incurred on the account.

  • Department Tasks / Responsibilities
    • Withdraw study from IRB (if applicable)
    • Invoice sponsor for all outstanding startup expenses
    • Notify CRF team via email regarding the closure/withdrawal [email protected]
      • Notify plans to spend out funds within 30 days of receipt OR
      • Provide the account number to transfer the residual balance to in accordance with close out procedures.
  • SPA Tasks / Responsibilities
    • CRF team to close out financial account
      • CRF team to apply F&A (if applicable)
      • CRF team to  transfer residual funds (if applicable)
    • Maintain institutional records