NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget & Research Plan
Network Group SDMCs
C. Network Group Statistics & Data Management Center Application
Specific instructions are provided on the following pages for the Statistics and Data Management
Center (SDMC) application. In general, except where noted below, all applications should conform to
the instructions in the PHS 398/SF424.
1. Detailed Budget for Initial Budget Period
The total cost budget requested by the Network Group Statistics and Data Management Center
(SDMC) in its application should be based on an algorithm used to estimate the total cost of
developing and conducting NCTN trials by both the SDMC and its associated Network Group
Operations Center that leads those trials (i.e., infrastructure costs).
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. The cost guidelines are
presented as ranges for total 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 (with separate estimated ranges related to intervention accrual versus nonintervention
accrual).
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.
In addition, the Network Group Operations Center must submit a Common Budget Outline as
described in Part 2 – Section II.A. of these Guidelines in conjunction with input from its
associated Network Group Statistics and Data Management Center. A sample table for the
Common Budget Outlines is provided in Part 4 – Appendices - Section IX. of these Guidelines.
The following budget guidelines apply specifically to the Network Group SDMC budget. The
categories listed below refer to those contained in the section of the PHS 398/SF424 entitled
"Detailed Budget for Initial Budget Period.” 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.
a) Personnel: A staffing plan for the SDMC, including position descriptions and
qualifications should be provided. Precise justification for the amount of effort
requested for each position is essential, including but not limited to the following:
� Statistics: Time and effort involved in developing statistical designs and analysis
plans for associated Network Group Operations Center clinical trials as well as
providing statistical analyses, interpretations, and conclusions with regard to study
data and supporting required results reporting per federal regulations in
www.clinicaltrials.gov as well as publication of those results in peer-review journals.
� Data Management: Time and effort involved in the development of case report
forms using NCTN–approved common data elements and the NCTN Common Data
Management System (CDMS) for trials, central registration and randomization of
patients onto clinical trials, collection and monitoring of primary patient data,
compliance with relevant data reporting and other regulatory requirements, and
conducting and/or supporting quality assurance activities for all NCTN trials the
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