Study Kick-off and Budget Development

All studies determined to be an Industry-Sponsored Clinical Trial require an internal budget prepared and approved by the Clinical Trials Research Management Group (CT RMG).

CT RPMs initially develop the internal study budget in partnership with the study team to estimate total project costs which is the basis for negotiating a fixed price per patient budget with the sponsor. The internal study budget contains confidential information. Stanford University does not share salaries with industrial sponsors. Stanford hospitals consider all hospital pricing confidential. Therefore, the internal budget should not be sent to sponsors.

RMG Research Financial Compliance Managers (RFCM) frequently refer to the internal study budget to compare planned versus actual expenditures.

Preparation of internal study budget follows many of the same Federal regulations and University policies as budgets prepared for submission to government agencies, for example budgeting effort, ensuring expenses are allowable, allocable and reasonable, and application of the appropriate Facilities and Administrative (F&A) rates.

The Kickoff Meeting includes all members of the study team, especially the Principal Investigator. At the meeting, attendees review the Coverage Analysis (if applicable), budget and payment schedule, and identify timelines and issues early in the process to avoid unnecessary delays. Effective Kickoff Meetings require a team effort and serves as a key step in the study start up process.