Closed/Withdrawn Prior to Activation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 TASK/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.
- Notify plans to spend out funds within 30 days of receipt
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