NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Network Lead Academic Participating Sites
treatment/intervention and/or randomization for trials with required or optional biospecimen
collections – this category of funding would not be expected to be given in association with
screening per case funding except in unusual circumstances. This funding is provided on a trial by
trial basis as approved by NCI/DCTD.
� High-Performance Intervention Per Case Management Funding for Lead Academic Participating
Sites: Funding to cover additional data management costs/workload and follow-up at institutions
(with acceptable audit standings) that enroll a large number of patients. It is anticipated that this
funding will be provided to Lead Academic Participating Sites for accrual at the main academic
center if the threshold accrual level for Lead Academic Participating Site awardees is sustained,
and it covers all follow-up data management costs for these patients. “High-Performance” per
case funding for affiliates that are included in a Lead Academic Participating Site grant award (i.e.,
if complete management services for the affiliates is provided by the Lead Academic Participating
Sites) may be possible, pending funds availability based on whether the affiliates meet special
threshold accrual levels for this category of sites set by NCI/DCTD each year.
Total costs for scientific leadership and coordination activities at the academic center (i.e.,
personnel, consultants, supplies, equipment, travel, and consortium/contractual costs)
should be based on a percentage of the total costs related to the estimated “intervention
per case management” funding plus a percentage of the total costs related to the estimated
“non-intervention per case management” funding for all patients enrolled to NCTN trials
each year at the academic center and affiliates. See Part 4 – Appendices – Section IV for
guidelines on the percentage to be used in the Type 1 application. Network Lead Academic
Participating Site budgets in significant excess of these guidelines are unlikely to be
supported.
The total amount of funding (i.e., the total cost budget request based on the algorithms for
“per case management” funding and scientific leadership and coordination for the Network
Lead Academic Participating Site application) should then be distributed to cover the “level
of effort” required to provide management services for patient enrollment on NCTN trials in
the categories listed below at the academic center and affiliates for which it provides
complete management services. If patients are accrued to study interventions in excess of
the “per case management” funding categories used to estimate the total cost budget for
the academic center, the center should submit an administrative supplement to cover the
additional patients accrued at the academic center and affiliates based on the “per case
management” funding categories for those patients.
1.2 Budget Categories for Funding “Level of Effort” Total Cost Budget Request
Once the Lead Academic Participating Site applicant has determined the amount of its total
cost budget request using the guidelines specified above, the applicant should provide a
“level of effort” budget based on the budget categories allowed for the application as
described below.
a) Personnel: A staffing plan for the Lead Academic Participating Site, including
position descriptions and qualifications should be provided. NOTE: Specific job
descriptions and qualifications for funded personnel (administrative as well as
scientific leadership) should be covered in this budget section and not repeated in
the research plan narrative. Precise justification for the amount of effort requested
for each is essential, including the following:
� Investigator Efforts: Research costs include the time and effort involved in
developing the research repertoire of NCTN trials to be activated at the Lead
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