Clinical Trial Budgets
Each study team supported by the Office of Clinical Trial Administration is assigned to a dedicated Budget Analyst. The OCTA Budget Analyst is delegated authority and responsibility to negotiate industry-sponsored study budgets on behalf of KUMC. Throughout the budget development and negotiation process, the Budget Analyst supports the study team by minimizing financial risk and assuring that KUMC and UKHS policies are followed. It is important to note that the cost to conduct a clinical trial will vary from site to site and based on the needs of the particular study.
Budget Development & Negotiation Process for Industry-Sponsored Clinical Trials
- Once the required Sponsor documents (Budget/CTA, ICF, manuals), Billing Matrix and internal quotes have been received through submission of the Clinical Research Start Up Form the Budget Analyst will work with the study team to build the initial draft budget.
- In order to complete a study budget, the Budget Analyst must have the final approved Billing Matrix/Coverage Analysis (if applicable). When the joint KUMC/UKHS Start-up Form is completed, relevant staff are notified so that work on the Billing Matrix/CA can begin. Pricing for clinical procedures will reflect the research rates of The University of Kansas Health System or another provider of services.
- In order to complete a study budget, the Budget Analyst must have the applicable internal quotes from special units performing study services such as Investigational Drug Services (Pharmacy), the CTSU and Hoglund. Information needed by these areas to complete their quotes is submitted as part of the Start-up Form. Additional follow-up by the study team may be required where indicated.
- To promote efficiency and minimize back and forth with the Sponsor, the Budget Analyst will clarify with the PI/Study Team: 1) the minimum amounts that can be accepted without escalation to the PI, for those budget items that are negotiable by the PI; and 2) the minimum total budget the PI is willing to accept.
- Once the budget has been approved by the Budget Analyst and Sponsor, the Budget Analyst will review and confirm that the budget amounts and billing terms have been successfully incorporated into the study contract prior to execution.
For additional information see RI Procedure for Activating Industry-Sponsored Clinical Research Protocols.
KUMC Research Institute, Inc.
|Payee Address:||University of Kansas Medical Center
Research Institute, Inc.
Mail Stop 1039
3901 Rainbow Boulevard
Kansas City, KS 66160-7702
|Mail Notices and Contracts to:||Lisa Hoebelheinrich, J.D.
Executive Director, KUMC Research Institute, Inc.
Associate Vice Chancellor for Research Administration, KUMC
|University / Federal ID:||48-1108830|
|Phone Number:||(913) 588-1242|
|Fax Number:||(913) 588-5729|
|Clinical Trial Fee Schedule:||Click here to open|