NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget & Research Plan
Network Group SDMCs
� Travel for persons on the SDMC staff who must attend the associated Network
Group Operations Center regular meetings.
� Travel for SDMC members to appropriate scientific research and administrative
committee meetings meeting held by the associated Network Group Operations
Center outside of regular meetings.
� Travel for SDMC leadership to attend NCI/DCTD – Network Group NCTN Leadership
Management Committee meetings for the NCTN Program or other NCI/DCTD
meetings on special initiatives of the NCTN Program.
f) Other Expenses: Research costs due to other expenses include those related to
communication and information dissemination with other key components of the NCTN
Program as well as with member institutions/sites of the NCTN Program. Also included
are costs of equipment rental and maintenance (copiers, telephones, computers),
postage, copying and printing, etc., justified quantitatively on the basis of previous
experience, where relevant. Applicants can also include expenses related to data
management for legacy studies from the former NCI-sponsored Cooperative Group
Clinical trials Program; however, such requests must be accompanied by a detailed
budget justification (not to exceed 1 page in the budget section) and would only be
funded based on unusual circumstances (e.g., very large and complex study).
g) Consortium/Contractual Costs: If costs are requested for consortium/contractual
participants, a separate detailed budget page, with appropriate justification, must be
provided for each arrangement. Indirect costs to consortium/contractual participants
are included in the direct costs of the SDMC. The SDMCs is encouraged to structure its
organization in a manner that minimizes the burden of indirect costs on the overall
SDMC budget.
2. Research Plan
In the “Research Plan” section of the Network Group Statistics and Data Management Center’s
application, a Specific Aims page should be provided as well as separate PHS 398 Research
Strategy Sections for the 3 sub-sections listed below within the corresponding specified page
limits (and the Table of Contents for the Research Plan section of the application should be
modified accordingly). The 3 sub-sections listed below consist of a Center Overview and 2
required functional components of a Center - i.e., (1) Statistical Analysis Program & Collaborative
Research and Collective Management and (2) Data Management Program.
Table of Contents for Network Group Statistics and Data Management Center application only
Specific Aims (including Impact Statement) - 1 page
Research Strategy Section for the Network Group Statistics and Data Management Center
Application – This section must consist of the sub-sections A-C described below.
A. Statistics and Data Management Center Overview - 12 pages
B. Statistical Analysis Program & Collaborative Research/Collective Management - 30 pages
C. Data Management Program - 30 pages
Other sections of the PHS 398 Research Plan (398 application instructions Part I, Section 5.5),
such as the sections for Letters of Support (e.g., Letter of Support from the institution or
organization supporting the Statistical and Data Management Center, Letter of Support from the
associated Network Groups Operations Center PD(s)/PI(s)) and Multiple Program
Director/Principal Investigator (PD(s)/PI(s)) Leadership Plan, remain unmodified and must be
completed following standard instructions.
Page 117 of 241