NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
B. Network Group Operations Center Application
Specific instructions are provided on the following pages for the Operations Center application. In
general, except where noted below, all Network Group Operations Center applications should
conform to the instructions provided in the PHS 398/SF424 grant application.
1. Detailed Budget for the Initial Budget Period
1.1 Estimation of Total Cost Budget Request
The total cost budget requested by the Network Group Operations Center in its application
should be based on 2 components described below, using guidelines provided in Part 4 –
Appendices – Section IV of these Guidelines:
(1) an algorithm used to estimate the cost of the data collection/management and
biospecimen collection (i.e., “per case management” funding) that will be provided
to the Network Group Operations Center’s member institutions/sites enrolling
patients on NCTN trials that do not receive “per case management” funding via
grants (e.g., Lead Academic Participating Sites grants, CCOP or MB-CCOP grants)
(2) an algorithm used to estimate the total cost of developing and conducting NCTN
trials (i.e., infrastructure costs) that the Network Group Operations Center leads
and collaborates on.
Guidelines for amounts to use in developing the total cost budget request for Type 1
applications are provided in Part 4 – Appendices - Section IV. of these Guidelines. These
guidelines include total cost amounts or ranges for the categories of:
� “per case management” funding for participating sites;
� infrastructure financial management coordination for the site by the Network
Group based on type of “per case management” funding being provided ; and
� other infrastructure costs for the Network Group Operations Center and its
associated Network Group SDMC to conduct NCTN trials led by the Network Group
based on estimated accrual to the trials (with separate estimated ranges related to
intervention accrual versus non-intervention accrual).
Applicants must use the amounts specified in these Guidelines for the different categories of
“per case management” funding that are to be provided to member sites in preparing their
budget. Applicants are not required to use the specific estimated ranges for infrastructure
costs provided in these guidelines (i.e., estimated ranges for infrastructure costs may be
adjusted by the applicant to fit its particular funding needs). However, total cost Network
Group budgets that include infrastructure costs based on estimated ranges that are in
significant excess of the estimated ranges provided in these Guidelines for infrastructure
costs are unlikely to be supported. These guidelines also provide a total cost range for
scientific leadership/coordination at “high-performance” pediatric sites based on accrual as
these sites do not have the option of applying for the Lead Academic Participating Site
awards.
1.2 General Information and Cost Categories
Since the organizational framework of each Network Group may be different, the Operations
Center budget should be presented in logical, discrete units, with specific budgets for each
unit (e.g., “per case management” funding for member sites, support for scientific
leadership, infrastructure cost categories such as administration, regulatory oversight,
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