Identify clinical services– Review the protocol to identify all services required for the clinical trial and who will pay for those services.  Services done solely for research purposes and paid by the sponsor/grant are labeled with an (R) and services done as part of standard of care or routine care and paid by insurer/patient are labeled (SOC).  If insurance is expected to cover Research or SOC costs, determine if preapproval will be necessary.

Prepare study budget –All study costs must be captured on the budget.  A budget template tool is available online to help you develop a complete budget complete with linked worksheets to prepare federal, nonfederal and sponsor budgets.  Use the appropriate Budget Template (Federal or Non-federal) to include all study related costs. Include costs of physician time for clinical and HOSPITAL services as professional fees or salary reimbursement for investigators (% effort). Use UT Price List to determine UT professional fees, tests and procedures. Contact other departments where research services will be provided for any special research pricing and CPT codes. (Department Contact List.)

Prepare sponsor budget – When entering costs on the nonfederal worksheet, the sponsor budget self-populates with each entry onto the Sponsor worksheet.  Use the sponsor worksheet to justify costs to sponsor.   Some sponsors require use of their template.  After visit totals or milestones are calculated on the Budget Template, transfer the totals plus indirect costs onto the sponsor template.

Negotiate budget with sponsor – Remember to add indirect costs on all study related costs when negotiating nonfederal budgets.  The negotiation for study budgets should be done by someone familiar with all study components. The Office of Sponsored Projects requires the complete and approved budget submitted with UTHSC-H Review and Approval Form.

Initiate internal review and approval – Complete Review & Approval form, attach the final approved Internal Budget Worksheet, which must show financial responsibility of research services as SOC or Research in designated column, and send for departmental and institutional review and approvals.