Frequently Asked Questions

Who invoices for UNeHealth studies?

SPA Accounting invoices for start-up costs and IRB fees unless other arrangements have been made between the Department and SPA Accounting. All other invoices are submitted by the Department Administrator who ensures the Study WBS is reconciled regularly.

Why is a CDA necessary? Who signs?

Confidential Disclosure Agreements (CDAs), are completed at the beginning of the Study review process to allow the PI to receive proprietary information (normally the Protocol and Investigator’s Brochure) related to the Study. Without a CDA, the recipients of confidential information are not prohibited from using and disclosing any confidential information received. Sponsor’s want to ensure that any such confidential information is appropriately protected.

A UNMC Authorized Signatory should sign CDA’s. If the PI is the party to and signs the CDA, they bear the responsibility and obligations of ensuring that all of the agreement terms are followed.

If we choose to use an external IRB for a study, how do they get paid?

Ideally, the Sponsor will work directly with the external IRB, which will submit all invoices directly to the Sponsor. However, there have been Sponsors who choose how to work directly or indirectly with an external IRB, so UNMC and/or the department has to act as the middle man. This is important to consider when deciding which IRB to use, as departments must weigh the costs of taking on those invoicing and payment responsibilities.

What if the Study is closed to enrollment, and the IRB is expiring, but all final payments have not been received, does the IRB have to be extended?

No, as long as there are no further activities taking place related to patient information. At this time, SPA Accounting will likely lock the account to new expenses, but keep it open to receive new revenue.

Is cost sharing allowed on an industry-sponsored clinical trial?

No, not without a waiver which requires justification and approval.

F&A Waivers are considered on a case-by-case basis by the Vice Chancellor for Research. Download the F&A Waiver Form.

How can the PI and Department help with Contract negotiations?

When asked, the PI and Department can be of help with communicating with the Sponsor.