NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
with applicable NIH Grants Policy requirements, which are provided on the NIH website at:
http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch15.htm. A statement that the
applicant organization and the collaborating organization have established or are prepared
to establish a formalized agreement that will ensure compliance with all pertinent federal
regulations and policies must be included in the application.
1.8 Common Budget Outline & Accrual Input by Member Institution/Site for Budget Request
The Network Group Operations Center must submit a Common Budget Outline as described
in Part 2 – Section II.A. of these Guidelines. A sample table for the Common Budget Outlines
is provided in Part 4 – Appendices - Section IX of these Guidelines. In addition to the
Common Budget Outline, the Network Group Operations Center must also submit a
breakdown of the accrual it anticipates from each of its member institutions/sites to all
NCTN trials over the project period that it used as input to generate its budget request. A
suggested format for a table to provide this information is presented in Part 4 – Appendices
– Section X of these Guidelines.
2. Research Plan
In the “Research Plan” section of the Network Group Operation Center’s application, a Specific
Aims page should be provided as well as separate PHS 398 Research Strategy Sections for the 5
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 5
sub-sections listed below consist of an Operations Center Overview and 4 required functional
components of an Operations Center (i.e., clinical trial development, member site accrual,
operational management, and collaborations and collective management of the NCTN Program).
Table of Contents for the Network Group Operations Center application only
Specific Aims (including Impact Statement) - 1 page
Research Strategy Section for the Network Group Operations Center Application
This section must consist of the sub-sections A-E described below.
A. Operations Center Overview - 12 pages
B. Clinical Trial Development Program - 30 pages
C. Member Site Accrual Program - 12 pages
D. Operational Management - 12 pages
E. Program for Collaborations and Participation in Collective Management - 12 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 sponsoring the Network Groups Operations Center) and Multiple Program
Director/Principal Investigator (PD/PI) Leadership Plan, remain unmodified and must be
completed following standard instructions. Also, a table listing member institutions for the
Network Group Operations Center should be included in the Resource section of the
application (see page 238).
2.1 Sub-Section A. Overview of the Operations Center (up to 12 pages)
In this sub-section, applicants are expected to provide a general overview of the proposed
Operations Center and describe the general features and operations of the Center. Include a
diagram illustrating the organizational structure of the proposed Operations Center and
outline how the Operations Center would interact with the other key components of the
NCTN Program.
2.2 Sub-section B. Clinical Trial Development Program (up to 30 pages)
In this sub-section, applicants are expected to address the following aspects:
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