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).
The Study Budget provides a critical tool for clinical trial financial management. CT RPMs initially develop the Study Budget to estimate total project costs which is the basis for negotiating a fixed price per patient budget with the sponsor. Post award, department staff utilize the Study Budget to help track expenses and payments. RMG Research Financial Compliance Managers (RFCM) frequently refer to the Study Budget to compare planned versus actual expenditures. Thus, the Study Budget serves multiple functions in the lifecycle of clinical trial finances.
The internal 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.
Preparation of 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.
Department study teams initiate the Clinical Trial Study Budget process via submission of required documents to the CT RMG intake process.
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. Study Budgets require a team effort and the Kickoff Meeting serves as a key step in the process.