Clinical Trials

Information relevant to clinical trials can be found on the pages within this section. While SPAdmin is involved in parts of these projects, the majority of the effort is handled by UNeHealth and the CRC's clinical research billing team.

UNeHealth (Industry-Sponsored Clinical Trials)

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.

Clinical Research Billing

The Clinical Trial Master Matrix (CTTM) is a tool that is used to record basic information about a clinical trial along with protocol specific scheduling of research related procedures/treatments and details on how these procedures/treatments will be billed.  A CTTM or "Matrix" must be completed for any study that includes clinical care activities conducted at Nebraska Medicine, UNMC, or UNMC-Physicians clinics or facilities irrespective of funding.  Information on the Matrix and UNMC's policy for Clinical Trial Billing (#8008) can be found on the UNMC policy wiki.

UNeHealth

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.

Which Contracts Run Through UNeHealth

UNeHealth contracts include:

Submit a New Contract

All new clinical trial submissions are to be submitted through the CRC.
Instructions for submission can be found on their Intake Form page.

The following documents will be required by UNeHealth to begin negotiation:

Your email communication with the sponsor may also provide valuable information to UNeHealth to help ensure timely negotiation.

UNeHealth Information for Sponsors (Tax ID, etc)

Sponsors typically require information from sites for the purpose of setting up contract templates, vendor payment systems, etc. In most cases, they request this information from clinical coordinators, so it is important for coordinators to understand that the information for UNeHealth contracts is different than for UNMC contracts. Please share UNeHealth information for the following when working with an industry sponsor:

Exceptions: All new master clinical trial agreements will be through UNeHealth, but existing UNMC masters are still in use until they can be converted.

UNeHealth Information
Parties to Agreement UNeHealth and Board of Regents, acting by and behalf of the University of Nebraska Medical Center
Indirect Rate 30% (From UNMC's Negotiated Rate for Industry-Sponsored Clinical Trials)
Fringe Benefit Rate Standard UNMC Rates
Legal Name UNeHealth
Organization Type Non-profit ancillary organization of the University of Nebraska formed by UNMC, authorized by the Board of Regents
Payee UNeHealth
Payee Type UNeHealth is the fiscal arm of the University of Nebraska Medical Center for the conduct of clinical trials
Financial Official
Payment Address
Linda Combs, BSBA
Accounting Manager
985090 Nebraska Medical Center
Omaha, NE  68198-5090
Phone:  402-559-5825
email:  lvondras@unmc.edu
or Craig Poole (cpoole@unmc.edu)
EIN/Federal Tax ID 47-0771713
W-9

UNeHealth W9 (Effective 1/1/22)
Contact UNeHealth Contract Associate

Contracting Address

UNeHealth
Attn: Chris Kratochvil, MD
985331 Nebraska Medical Center
Omaha,  NE  68198-5331

Phone: 402-559-7614
email:  unehealthdist@unmc.edu

Human Subject
Assurance Number
FWA 00002939
NPI Number 1790042786

Clinical Research Billing

Clinical Trial Master Matrix

The Clinical Trial Master Matrix (CTTM) is a tool that is used to record basic information about a clinical trial along with protocol specific scheduling of research related procedures/treatments and details on how these procedures/treatments will be billed.  A CTTM or "Matrix" must be completed for any study that includes clinical care activities conducted at Nebraska Medicine, UNMC, or UNMC-Physicians clinics or facilities irrespective of funding.  Information on the Matrix and UNMC's policy for Clinical Trial Billing (#8008) can be found on the UNMC policy wiki.

Coverage Analysis

Coverage Analysis uses the Matrix to verify what is conventional "standard" care as opposed to research only costs to identify what can or cannot be billed to a third party payer (either private insurance or Medicare).  The Coverage Analysis process also compares the Matrix, Informed Consent Document (ICD), and preliminary budget to ensure that all costs are  covered, thereby assuring that the study budgets reflect the true cost of research.

When is a Matrix and/or Coverage Analysis Required?

Any study that includes clinical care activities conducted at Nebraska Medicine/UNMC/UNMC-Physicians clinics or facilities regardless of the funding source or lack of funding source. Examples may include but are not limited to:

Research that DOES NOT Require a CTMM and CA

Any study that does not include clinical care activities or has no potential to create a bill for technical fees and/or professional fees for Nebraska Medicine/UNMC/ UNMC-Physicians clinics or facilities. Examples may include but are not limited to:

When and How to Submit Documents