UNeHealth is the contracting and fiscal arm for industry-funded clinical trials on behalf of University of Nebraska Medical Center. It is housed under Center for Clinical and Translational Research (CCTR), operating under the direction of Dr. Christopher Kratochvil, Chief Medical Officer for UNeHealth and Associate Vice Chancellor for Clinical Research.
The UNeHealth partnership
- Provides a “front door” for industry sponsors
- Creates system-wide efficiencies to better support investigators and engage sponsors
- Develops resources for the enterprise that position us to grow clinical research
Which Contracts Run Through UNeHealth
UNeHealth contracts include:
- Clinical trial agreements involving investigational drugs or devices
- Master clinical trial agreements
- Compassionate use agreements
- Emergency use agreements
- PI-initiated clinical trial agreements
- Material transfer of drug related to patient-oriented research or compassionate use
Industry-sponsored clinical trial agreements are the key focus of UNeHealth, whether initiated by a sponsor or by a UNMC investigator. The clinical trial may test the safety and/or effectiveness of drugs, devices, treatments or it may test preventive measures in humans. The sponsor typically provides the study drug or device, financial support and proprietary information, while the university provides data/results, publications or input.
Where to Start
As the investigator, to ensure a smooth start-up, build a team. After identifying a study, notify your department administrator, clinical coordinator and/or the UNeHealth Contract Office Associate who can guide you through UNMC’s research infrastructure and help you identify next steps and individuals to support you.
Submit a New Contract
Email the following documents to the UNeHealth Contracts Office Associate, Amanda Leingang:
- Editable contract template from sponsor
- Contract Questionnaire
Your email communication with the sponsor may also provide valuable information to UNeHealth to help ensure timely negotiation.
UNeHealth contract negotiators will review and negotiate your contract. New contracts are parked in a queue and available to all until a negotiator is able to start the review.
UNeHealth contracts are signed by the sponsor and an authorized UNeHealth signatory. The investigator may sign but only as having read and acknowledged. UNeHealth coordinates the signature process and informs the IRB when the contract is fully-executed so the IRB can be released.
UNeHealth strives to execute contracts within 75 days of receiving the required documents from the department. Some require less time; some more. Variables that impact timelines include volume of contracts under review, sponsor responsiveness, terms requiring negotiation, and whether UNeHealth/UNMC has an institutional master agreement with the sponsor.
Investigators can favorably impact contract timelines by making sure departmental staff finalize the budget and submit it to UNeHealth within 60 days of submitting the contract for review. Your contract will not be signed by UNeHealth or the sponsor until the budget is attached to the contract. Click here for tips on expediting your contract. Click here for more information on Roles and Responsibilities.
UNeHealth sets up the WBS as soon as the contract is fully-executed, the IRB is released, financial conflicts of interest are managed, and internal forms are fully-approved. UNeHealth monitors each process to completion, then bundles the award and notifies the investigator and department administrator when the WBS account is set up.