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Grants & Contracts

Ending or Extending Clinical Trial Closeout Procedures

Clinical Trial project end dates are based on the Clinical Trial Agreement terms and Institutional Review Board (IRB) approval. If a clinical trial is over before the end date of the Agreement, contact the Office of Research Administration (ORA) to have the project/grant officially terminated. ORA will then notify Grants and Contracts Accounting (GCA) of the new end date. Many issues may affect the need to keep a clinical trial open beyond the original projected end date. If additional enrollment, follow-up, or other patient contact is needed to complete the clinical trial, ORA will work with the Sponsor to extend the end date of the agreement if it cannot be extended internally. End dates can only be extended beyond the agreement end date with the appropriate current IRB approval and Sponsor approval.

If all patient follow-up and any activities required by the protocol have been completed, or the IRB has been inactivated, the project/grant (C Account) must be closed and no extensions can be approved by ORA.

Clinical trials extensions should not be requested for anticipated deposits, cost transfers, or to pay sporadic administrative invoices. Please note costs on these invoices need to occur within the time period of the award. If deposits or invoices need to be processed 60 days beyond the study end date, please contact Grants and Contracts Accounting.

Residual Funds:

If residual funds remain in an account at the end of the trial and the clinical trial agreement requires unspent funds to be returned to the sponsor, GCA will return the funds in accordance with the contract. Residual funds that do not have to be returned to the sponsor will be treated as follows: (1) For awards where 60% or more of the budgeted direct costs have been properly charged to the project (i.e. at least 40% residual), the remaining direct cost balance of the award will be transferred to the applicable Department Chairman, to be used at their discretion. (2) When less than 60% of the budgeted direct costs have been properly charged to the project, the direct cost balance in excess of the 40% residual will be transferred with 50% going to the Department Chairperson, to be used at their discretion and 50% to the VP of Research, to be used for the support of research. The remaining 40% will be transferred to the applicable Department Chairperson as above. Residual funds that do not have to be returned to the sponsor will not be transferred to the Principal Investigator and may not be transferred to another institution should the Principal Investigator leave OUHSC. Prior to the residual balance transfer, F & A costs will be reviewed and adjusted as necessary. Note: F & A costs will be assessed on any transfers of residual funds. (This policy applies to All Awards: Research, Clinical Trials, Pre-Clinical, etc.).

Example I.

Budgeted Direct Costs: $100,000
Budgeted F&A Costs: $ 20,000 (20% F&A for illustration purposes)
Total Budget: $120,000
Actual Direct Expenditures: $ 60,000
Actual F&A Charges: $ 12,000
Remaining Direct Funds: $ 40,000 (returned to Dept Chair)
Remaining F&A Charges: $ 8,000 (assessed at time of transfer of funds)

Example II.

Budgeted Direct Costs: $100,000
Budgeted F&A Costs: $ 20,000
Total Budget: $120,000
Actual Direct Expenditures: $ 50,000
Actual F&A Charges: $ 10,000
Remaining Direct Funds: $ 50,000
$ 45,000 (returned to Dept Chair)
$ 5,000 (Vice President for Research)
Remaining F&A Charges: $ 10,000 (assessed at time of transfer of funds)