Study Kick-off and Budget Development

Overview

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 [link].  The Study Activation Form [link] is used by the study team to request a Kickoff Meeting.

The Kickoff Meeting includes all members of the study team, especially the Principal Investigator. At the meeting, attendees review the 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. 

How to request a KO meeting

Study teams initiate a clinical trial budget through the Intake Process, which includes the submission of the minimum documents to RMG Intake Team.

Upon receipt of the minimum documents, CT RMG Intake sends out three separate emails:

  • An email to the Study team with the study SPO number that can be added to their IRB application and the names of the CT RPM and CT CO who will be working on the study.
  • An email to the Study team to request possible dates for the Kickoff meeting.  Kickoff meetings can be in person, by telephone or via Zoom.
  • An email to the study sponsor contact(s) to provide the names of the CT RPM and CT CO who will be working on the study.  

 

The CT RMG Intake team schedules the Kickoff meeting. At the Kickoff meeting the internal budget will be discussed along with the contract budget, contract issues, study timelines, compliance tasks and issues.

The internal budget (confidential) includes the following costs:

  1. Startup costs, including study team startup effort, advertising, University IRB fees and School of Medicine fees.
  2. Per patient fee, all personnel, effort.  Patient care services determined to be research related and not standard of care.
  3. Invoiceable items, e.g., IRB renewal fees, SAE reporting, etc.

Patient care services billed to insurance are not included in the internal budget, which only includes the study costs paid by the sponsor.

Once the PI approves the internal budget, the CT RPM prepares the external budget and submits it to the sponsor.  As needed, the CT RPM negotiates the contract budget, makes final revisions and finalizes the contract budget.

The CT RPM serves as the Institutional Official for submitting and negotiating the clinical trial budget with the sponsor, and holds institutional authority to perform this task on behalf of the University. Study team members do not have this institutional authority.

Once the sponsor approves the clinical trial budget and the PI accepts the funding as sufficient, the CT RPM routes the budget via the SeRA system.  After the PI approves the budget in the system via the Proposal Development Routing Form (PDRF), the CT RPM approves as the institutional official.

The CT CO can only sign the contract after budget approvals in SeRA and the IRB reviews and approves the study.