Creighton University

Externally Sponsored Contracts (including Clinical Trial Agreements) must be approved by the Grants Administration Offce and Legal Counsel at Creighton University.  A detailed description of how to process an externally sponsored contract/agreement is below.  A printable version in checklist form is also available.  Please contact Grants Administration at 280-1175 with any questions. 

Printable Checklist of How to Route an Externally Sponsored Contract/Agreement

Principal Investigator (PI) or designee e-mails a draft of the contract/agreement in Microsoft Word format to bherr@creighton.edu in the Office of Grants Administration (OGA) for Legal Counsel pre-review.

Legal Counsel will review draft and make required changes or comments using track changes mode in Microsoft Word. (See required elements in an Externally Sponsored Contract/Agreement)

Legal Counsel will return e-mail to the Principal Investigator (PI) and/or designee with instructions to return contract/agreement to sponsor requesting the changes.

Once a corrected contract/agreement is obtained the PI or designee delivers contract/agreement signed by the PI, the study budget, protocol or statement of work and the Creighton University Proposal Routing form to the OGA.

• IMPORTANT:  Please allow at least three to five business days for the following review, approval and signature process.

The OGA reviews that:

• All attachments/exhibits referenced in the contract/agreement are included;
• The study protocol or statement of work has been submitted;
• The PI signed the contract/agreement;
• The Creighton University Proposal Routing form is complete including the signature of the PI, key personnel, other faculty and their respective department chair(s).

If items or signatures are missing, the OGA contacts the PI or designee.  If corrected copies cannot be obtained within 24 hours, the OGA will require that all documents be picked up and returned to the OGA when the complete package is availabe.

If all required items are included and signed, the OGA verifies that a Financial Conflict of Interest (FCOI) Disclosure form is on file for the PI, all key personnel, and other research staff as indicated on the Creighton University Proposal Routing form.

• If a FCOI Disclosure form is missing, an e-mail is sent directly to that individual with a copy to the Associate Vice President for Research and Compliance.
• The e-mail will indicate the name of the individual whose disclosure indicated they had a conflict, the title of the project, and the sponsor name for the necessary follow up with the FCOI Committee.

The OGA then reviews the documents for the following:

• Corrections requested in contract/agreement pre-review have been incorporated;
• Study budget calculation errors;
• Consistency of study budget figures with the figures quoted in the contract/agreement;
• Inclusion of appropriate indirect cost rate and regulatory fees (IRB, start-up costs, waste removal, etc.);
• Verification that budget figures listed on the Creighton University Proposal Routing form are consistent with the budget documents submitted with the contract/agreement.

Entire package is singed off by the OGA and then hand delivered to the respective Dean's office for review and signature approval.

Entire package is hand delivered to Legal Council for a review that all recommended changes were made and signature approval.

Entire package is hand delivered to the Vice President for Administration and Finance for review, approval and signature approval.

The OGA will contact the PI or designee to pick up the package to return to the sponsor:

• If the contract/agreement had not been signed by the sponsor, all originals will be returned to the Pi and a copy held in the OGA until a fully executed original is returned;
• If the sponsor had already signed the contract/agreement, the OGA will retain one original and return the remaining original(s) to the PI to return to the sponsor;
• A copy of the Creighton University Proposal Routing form will also be returned to the PI.