Budgeting

In addition to the Coverage Analysis charge designations for your research study, the OCR offers budget creation and negotiation services. The OCR works with investigators and their study team to develop budgets for clinical trials and negotiates terms with industry sponsors. OCR Budgets can be developed after a preliminary coverage analysis has been approved, unless fully funded by the Sponsor. 

The budgeting team can help to:

  • Develop protocol-specific budgets and negotiate with sponsors to ensure adequate financial support
  • Assist the PI in projecting the costs for investigator-initiated trials
  • Ensure the use of standardized costs for research procedures and clinical trials across multiple programs
  • Ensure that budget and payment terms within contracts are accurately executed

For questions about budgeting, please contact Cat Savangsy at [email protected].

New! Budget Template for Industry-Sponsored Clinical Trials

The Industry Template (template download coming soon) is used for budgeting for industry sponsored clinical trial studies. This template should be customized according to the specifications of each study.  Per UCSF policy 95.5, the budget must be adequate to cover the entire cost of the study.  UCSF is not allowed to subsidize any sponsor related cost.  The template is broken down into following four sections as follows:

  1. Protocol Required Procedures:  Please enter the appropriate procedure and cost by inserting the pricing for each procedure item at the correct interval in the timeline.  Only procedures that the coverage analysis has determined to be research and billable to sponsor should include pricing.  If the procedure is billable to insurance, please enter “SOC” into the applicable timepoints.  If there is a CPT Code for the procedure, please enter the code in the CPT Codes Column.  Once the code is entered, the price will automatically populate in in the cost column.  For research items like dispensing fees were a CPT code is not available, please use “Flat Rate” and enter the cost into the cost column.
  2. Study Personnel Cost:  The Time and Effort should be customized to match the required personnel and time for each study.  Enter the appropriate personnel and yearly salaries on the Salary Calculations Tab.  Then enter the hours under the applicable timeline for the research hours required.  Just a reminder to include time for non-protocol specific task like answering queries and reviewing documents.
  3. Institutional Required Fees:  UCSF considers all listed fees to be non-negotiable.  Please only remove fees if they are not required for the study.  For example, both the Expedited and Full IRB fees are listed.  The Expedited rate may be removed if not required for the study.  Additional fees may be added if required for specific studies.  Please update the frequencies when appropriate depending on the patient accrual and length of study.
  4. Invoiceable Cost:  This section should include the cost for all procedures where cost is variable or the procedure is optional.  Examples include scans where several options are available or pregnancy test that are only applicable to women of childbearing age.  Also, please update the frequency depending on the patient accrual and length of study.