Corporate & Industry Sponsored Clinical Trial Policy Statement

This policy is effective on all projects with an effective or start date on or after April 1, 2003.  Last updated: April 15, 2016

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

For corporate and industry sponsored clinical trials with an effective or start date prior to July 1, 2016, the University's minimum Facilities & Administrative (F&A) rate is 25% of total direct costs.  For new clinical trials after July 1, 2016, the minimum rate is 26% of total direct costs.  If the sponsor insists on paying a lower F&A rate (for example, 20%), the minimum rate will still be assessed on the funds.

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.   

Accounting Issues

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.

Project Close-Out

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.

Residual Balances

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.