Frequently Asked Questions - Clinical Trials
A study meeting the UCI definition of a clinical trial will be conducted as a cooperative group trial under NIH funding. Can the clinical trial facilities and administrative cost rate of 32% TDC be used?
No. Studies supported in whole or in part with federal funding must apply the applicable Federal research facilities and administrative cost rate.
A study will be funded by an industry Sponsor via a subcontract to UCI, with prime funding provided by the Federal government. Since the funds will be received directly from the industry Sponsor, can the clinical trial facilities and administrative cost rate of 32% be applied?
No. Because Federal flow-through funds are involved, the applicable Federal research facilities and administrative cost rate should be applied.
A study fully funded by a for-profit entity will involve testing of an investigational drug or device in animals. Which facilities and administrative cost rate applies?
The clinical trial indirect rate only applies to clinical testing in human subjects. Pre-clinical laboratory and animal studies are specifically excluded. Therefore, the applicable Federally-negotiated research facilities and administrative cost rate would apply.
A pharmaceutical company has requested that the University run specialized tests on samples obtained in a clinical trial. Would the clinical trial facilities and administrative cost rate apply?
No. The clinical trial rate applies only to studies involving the direct clinical testing of investigational products in human subjects. If the University's sole involvement is to run tests, the applicable Other Sponsored Activities rate would apply.
An investigator has agreed to analyze data collected in an industry-sponsored clinical trial conducted at both UCI and other sites. Which facilities and administrative cost rate applies?
The applicable Federally-negotiated research rate would apply.
The University has been asked by a for-profit sponsor to recruit and enroll human subjects in order to collect data that will be submitted to a patient registry. Is this considered a clinical trial, and would the clinical trial facilities and administrative cost rate apply?
Data collection studies for registry purposes, even if human subjects are involved, are not considered clinical trials. Therefore, the clinical trial facilities and administrative cost rate would not apply, and the applicable Other Sponsored Activities facilities and administrative cost rate should be used.