Budget Development

After internal review of the minimum required documents, the Clinical Trial Research Process Manager (CT RPM) begins Budget Development. While there are some parts of Budget Development that may be completed by the CT RPM before the Kickoff Meeting (e.g., populating salary information and study team effort calculations), the majority of Budget Development takes place during, and possibly after, the Kickoff Meeting.

During Budget Development, the CT RPM works with the study team to discuss:

  • PI approval of Coverage Analysis
  • Gaps that have been identified between the internal budget and sponsor’s payment schedule,
  • Compliance issues needing resolution prior to finalizing the budget, and
  • An action plan, developed in conjunction with the study team, to resolve any outstanding issues.

If the internal budget cannot be completed by the end of the KOM, both the study team and the CT RPM assume responsibility for outstanding portions of the budget still requiring resolution. Ultimately, the CT RPM and study team work toward understanding and documenting the estimated costs of conducting a study at Stanford, broken down into start-up, per patient amount, and invoiceable fees, while addressing all clinical research compliance issues prior to negotiating the budget with the sponsor.

How to estimate site costs for a negotiable per patient CT budget: