A Payment Schedule is a sponsor’s proposed payment plan for site participation in a clinical trial (CT). As part of the sponsor start up package, the sponsor provides a Payment Schedule to each site and/or the research team as an exhibit attached to the Clinical Trial Agreement (CTA) or a detailed section within the draft CTA.
Clinical Trial Research Management Group (CT RMG) requires the Payment Schedule as one of the Minimum Documents for study set-up. For investigator-initiated, industry sponsored CTs, a Payment Schedule may not be available from the sponsor at the time of Study Set-up and is not required.
It is important for the study team and their financial manager to understand and agree on:
- the amount of funding provided by the sponsor,
- the payment structure, and
- any associated payment terms.
Study teams use the final version of the Payment Schedule to set up the study budget in the Clinical Research Invoicing System for Participants (CRISP).
How to review the Payment Schedule
Sponsors can provide different types of payment schedules that should be reviewed to understand the sponsor’s offer.
Sponsors may offer different payment structures that may include any of the following:
- a per subject payment either as a flat per visit amount or a detailed per visit payment that itemizes each procedure or clinical service required per protocol’s Schedule of Events
- payments to cover costs not included in the per subject payments, e.g. invoiceable items
- site fees or start-up costs, e.g. IRB fees, pharmacy fees
- details on the financial terms behind the Payment Schedule and specific line items
- when the sponsor requires Stanford to submit an invoice
- when the sponsor pays Stanford based on Case Report Form (CRF) completion/monitoring
- details on partial payment withholdings
- indirect cost rate (IDC) may or may not be detailed
CT RMG assists in developing a cost estimate for conducting the study at Stanford for comparison with the sponsor’s Payment Schedule. As part of the comparison, CT RPMs will work with the study teams to assess the gaps between Stanford costs and the sponsor’s budget. A strategy for addressing the gaps during negotiation with the sponsor will be discussed during the study Kick Off Meeting.
As a non-profit, academic institution that receives federal funding, all funding provided to Stanford investigators for clinical trials is managed in compliance with the federal government’s OMB A-21: Cost Principles for Educational Institutions and the Uniform Guidance. CT RPMs review the Payment Schedule to confirm it is compliant with federal regulations and with all established University polices and accounting practices.