Confidential Research Hotline (402-280-3200)
Research Personnel are expected to report any known or suspected noncompliant conduct related to research or sponsored program activities conducted and/or approved through Creighton University. The confidential Research Compliance Hotline (402-280-3200) is available for any individual who wishes to remain anonymous and/or has found other available reporting mechanisms to be ineffective. Research Personnel may also address their research compliance-related questions or concerns to Kathy Taggart, Associate Vice President for Research and Compliance, at 402-280-2360.
How to Submit an Externally-Sponsored Contract/Agreement
Externally-sponsored contracts (including Clinical Trial Agreements) must be approved by Sponsored Programs Administration 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 Sponsored Programs Administration at 402-280-1175 with any questions.
- Principal Investigator (PI) or designee will e-mail a draft of the contract/agreement in Microsoft Word format to email@example.com in Sponsored Programs Administration for Legal Counsel pre-review.
- Legal Counsel will review the draft and make required changes or comments using track changes mode in Microsoft Word. (See Checklist of Required Elements in an Externally Sponsored Contract/Agreement (PDF)
- 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 will deliver the contract/agreement signed by the PI, the study budget, protocol or statement of work, and the Creighton University Proposal Routing Form (PDF) to Sponsored Programs Administration.
IMPORTANT: Please allow at least three to five business days for the following review, approval and signature process.
- Sponsored Programs Administration will review 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 (PDF) is complete including the signature of the PI, key personnel, other faculty and their respective department chair(s).
- If items or signatures are missing, Sponsored Programs Administration will contact the PI or designee. If corrected copies cannot be obtained within 24 hours, Sponsored Programs Administration will require that all documents be picked up and returned to Sponsored Programs Administration when the complete package is available.
- If all required items are included and signed, Sponsored Programs Administration will verify 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 (PDF).
- If the database does not indicate a FCOI Disclosure form on file, an e-mail will be sent directly to that individual with a copy to the Associate Vice President for Research and Compliance.
- If the database does indicate a FCOI Disclosure form on file, but the investigator disclosed a conflict, an e-mail will be sent to the Associate Vice President for Research and Compliance indicating 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 Conflict of Interest Review Committee.
- Sponsored Programs Administration will then review 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 will be signed off by Sponsored Programs Administration and hand delivered to Legal Counsel for a review that all recommended changes were made and for signature approval.
- Entire package will be hand-delivered to the respective Dean and Associate Vice President for Research for review and signature approval.
- Entire package will be hand delivered to the Associate Vice President for Research and Compliance for review, approval and signature approval.
- Sponsored Programs Administration will contact the PI or designee to pick up the package to return to the sponsor:
- If the contract/agreement is not signed by the sponsor, all originals will be returned to the PI and a copy held in Sponsored Programs Administration until a fully executed original is returned;
- If the sponsor has already signed the contract/agreement, Sponsored Programs Administration will retain one original and return the remaining original(s) to the PI to return to the sponsor;
- A copy of the signed Creighton University Proposal Routing Form (PDF) will also be returned to the PI.