BUDGET DEVELOPMENT PROCESS
1. Identify clinical services – Requires listing all services required for clinical trial and who will pay for services “determination of clinical research services” on appropriate Internal Budget Worksheet as research related services paid by contract/sponsor (C) vs. standard of care/routine services paid by insurer/patient (SOC). Prepare study budget –Use appropriate UTHSC-H Study Budget Worksheet (Federal or Nonfederal) to identify all study related costs* and use UT Clinical Research Price List for UT professional fees, tests and procedures. Contact other departments where research services will be provided for any special research pricing and CPT codes. o Clinical Trial Budget Template o UT Price List Clinical Research Services [Restricted access] o All expense-based costs/per patient must be shown o Research staff time and effort may be designated by an “x” in the appropriate item and visit. Prepare sponsor budget (optional) – Use Sponsor Budget Worksheet to justify costs to sponsor ** Negotiate budget with sponsor – Negotiate budget at the department level. The Office of Sponsored Projects requires the complete and approved budget submitted with UTHSC-H Review and Approval Form. Initiate internal review and approval using UTHSC-H Review and Approval Form - Prepare Review & Approval form, attach the final approved Internal Budget Worksheet, which must show financial responsibility of research services as SOC or Contract in designated column, and send for departmental and institutional review and approvals.
2.
3. 4.
5.
*Include costs of physician time for clinical and HOSPITAL services as professional fees or salary reimbursement for investigators (% effort) **For a consultation please contact: Catey Carter, RN - 713-500-3524