This policy is effective on all projects with an effective or start date on or after April 1, 2003. Last updated: 12/15/2022
Corporate and industry sponsored clinical trials are studies supported by a corporation and which involve evaluation of a technology or product. These studies include Phase I-IV human studies. The agreements must be entered into in the name of the University of Iowa and routed through the Division of Sponsored Programs (DSP).
Facilities & Administrative Costs
The University's F&A rate for all CFCTs is 30% of total direct costs (TDC). See University Operations Manual II-27.7(d)(1). If the corporate funder insists on paying a lower F&A rate (for example, 20%), 30% will still be applied and the investigator must decide whether the research can be performed for the amount that is available for direct costs.
- Clinical investigations as defined by the FDA in 21 CFR 50.3(c)(link is external);
- Clinical investigations as defined by the FDA in 21 CFR 312.3(b)(link is external);
- Phase 1, 2, and 3 IND clinical investigations as defined by the FDA in 21 CFR 312.21(link is external);
- Phase 4 postmarketing studies as defined by the FDA in 21 CFR 312.85(link is external);
- Investigations as defined by the FDA in 21 CFR 812.3(h)(link is external) regarding IDE studies; or
- Postmarket surveillance as defined by the FDA in 21 CFR 822.3(i)(link is external) related to medical devices.
Non-interventional studies, including observational, registry and retrospective chart reviews, are not considered CFCTs for purposes of the University’s F&A cost rate, unless they satisfy any bulleted item above.
A portion of the F&A rate equal to the departmental administration component of the rate will be returned to departments to be used at the discretion of the department head.
Establishing the Account
When the contract is fully signed and the Human Subjects Office authorizes the IRB to release approval documents, DSP will release the agreement to Grant Accounting. Once Grant Accounting assigns the MFK (account) for the project, they will release the Award Activation Authorization Notice (AAAN) to the PI/department along with a copy of the fully executed agreement and the MFK.
All revenues and expenses applicable to the project must be accounted for in the University accounting system. The PI/department should charge all costs applicable to the project to the established account.
Invoicing of start-up fees that do not require the completion of a specific task or milestone prior to the submission of the invoice will be completed by Grant Accounting. Any other invoicing related to the project will be completed by the PI/department. All payments must be directed to the University of Iowa, Grant Accounting Office. The PI/department are responsible for ensuring that payments are received as expected.
If the contract does not specify a project end date, the end date will be identified as three years after the start date. If the project is not complete by or is terminated before this date, the PI/department will need to notify DSP to adjust the project end date. Grant Accounting will use the established project end date to initiate the project close-out procedures. The PI/department will be allowed 90 days after the project period end date to make appropriate adjustments and corrections to the project account and determine if a residual balance exists.
Any residual balance will be moved at close-out, and only after Grant Accounting confirms with the PI/department that the project is complete, all necessary deliverables have been provided, and all applicable costs have been charged to the project.
When a project ends in a surplus and the sponsor does not require the funds to be returned, F&A will be assessed on the remaining balance. The remaining balance will be transferred to an Organized Activity (fund 240) account identified by the PI/department. The account will be administered by the department with expenditures directed by the PI who originally obtained the funds as long as that individual is a regular faculty or staff member of the University.
In cases where the PI leaves the University of Iowa after the project has been closed out, any funds remaining will be transferred to the DEO of the PI's department for discretionary use in research at The University of Iowa.