Instructions for Completing the BGTC Clinical Trial Budget Worksheet

Sep 13, 2026

Instructions explain how to complete the BGTC Clinical Trial Budget Worksheet, required for applications to present a budget summary in the same format as other applicants. Applicants must first build a more detailed budget estimating expected clinical site costs, then submit both the completed worksheet and the detailed forms. The guidance covers planning and execution phases up to a 24-quarter timeline, visit-based cost differences, and how the worksheet groups costs into screening, study, and follow-up categories, including special budgeting steps for anti-AAV capsid antibody testing via a central lab while excluding assay performance costs.

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Instructions for Completing the BGTC Clinical Trial Budget Worksheet

Preparing a Detailed Budget for the Application

Planning Phase and 24-Quarter Execution Phase Timeline

Visit-Based Cost Grouping and Follow-Up Limits

Special Note: Anti-AAV Capsid Immunological Testing Budgeting

Instructions for Completing the BGTC Clinical Trial Budget Worksheet The BGTC Clinical Trial Budget Worksheet is a required part of the application, which will allow our reviewers to see a summary of your proposed clinical trial budget in the same format as the submissions from other applicants. In order to complete this budget summary, you will first need to prepare a more detailed budget that accurately estimates all of the expected clinical site costs of your proposed clinical trial. To develop that more detailed budget, you are free to use any budget form you prefer (e.g., perhaps your institution’s own preferred clinical trial budget form) . Please submit BOTH the completed BGTC Clinical Trial Budget Worksheet and your own more detailed budget forms with your application. As mentioned in the BGTC Clinical Trial RFP, any BGTC clinical trial that will have a trial site in California (and/or will be organized by a lead Principal Investigator based in California) is encouraged to apply in parallel for funding by the California Institute for Regenerative Medicine (CIRM) . To facilitate parallel applications to CIRM, instead of developing a wholly different budget worksheet, we modified the CIRM budget worksheet to produce this BGTC Clinical Trial Budget Worksheet. The modifications consist primarily of our having removed non-clinical or sponsor-related cost categories that are not expected tobe requested by the clinical trial Applicants responding to this RFP. In that regard, please see the table in Section VI “Roles and Responsibilities” in the BGTC Clinical Trials RFP for a delineation of which clinical trial activities are the responsibility of the Applicant, versus which activities will be centralized and carried out by the BGTC (i.e., by NIH or FNIH, BGTC manufacturing partners, or CDMOs/CROs hired by the BGTC) . Please contact FNIH with any specific questions you may have in that regard. Of note, we have also modified the Budget Worksheet to allow for a longer study duration, of up to 6 years, reflecting the fact the FDA often requires 5 years of follow-up after a patient is dosed with an AAV gene therapy. Specifically, the BGTC Clinical Trial Budget Worksheet contains spaces to report the expected costs for a “Planning Phase” of variable length (more on that below), followed by a 24-quarter (i.e., 6-year) clinical trial “Execution” Phase,” which begins at the time of study launch. Figure 1. Example of a possible BGTC “Execution Phase” timeline in terms of years and quarters (“Q”) from the time of study launch. A “Planning Phase” proceed each study launch. Figure 1 provides an example of a possible timeline for the Execution Phase of an individual BGTC clinical trial. The lower portion of that figure uses the same terms of “Screening,” “Study Visits,” and “Follow-Up Visits” that are used by the BGTC Clinical Trial Budget Worksheet. An individual patient will, of course, move sequentially through screening, enrollment, administration of the AAV gene therapy, a primary analysis period during which the effects of that treatment are most intensely studied, and a period of further follow up during which the frequency and cost of assessments is expected to be reduced, but necessary safety and key outcome measurements can still be collected. As per the BGTC Clinical Trial RFP, the general expectation is to perform the primary outcome assessments for the trial within 1-2 years. The follow-up of treated patients may extend beyond that timepoint, as warranted for the indication and/or FDA requirements, but BGTC will not fund follow-up for longer than 5 years. In both your clinical trial protocol’s Schedule of Assessments and your detailed clinical trial budget, you will need to account for the fact that different clinical trial visits have different costs (e.g., specific lab tests done at an initial screening visit, versus procedure costs during the AAV treatment visit, versus repeated clinical re-assessments or other te

FAQs

What must applicants submit with the BGTC Clinical Trial Budget Worksheet?

Applicants must submit the completed BGTC Clinical Trial Budget Worksheet and their own more detailed budget forms estimating expected clinical site costs.

What phases and timeline structure does the BGTC worksheet use?

The worksheet includes a variable-length “Planning Phase,” followed by a 24-quarter (6-year) “Execution” Phase beginning at study launch.

How does the worksheet handle costs across different visit types?

It summarizes visit costs by averaging multiple distinct visits into three categories: Screening Visits, Study Visits (including treatment and primary analysis period assessments), and Follow-Up Visits.

How should applicants budget anti-AAV capsid antibody testing?

Budget for collecting and sending anti-capsid antibody test samples to a central laboratory chosen by BGTC, but do not budget for the assay performance cost, since BGTC covers it through a separate mechanism.

Sep 13, 2026

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