NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Applications Section II – Budget & Research Plan – General Info
II. New Applications Format and Budget Considerations
A. General Information and Common Budget Outline for Network Group
All applications for key components of the NCTN Program must follow the PHS 398/SF424 format for
new applications, including formatting and page limitations except as modified below. The
applications should describe the scientific and administrative experience of key personnel and should
include and follow the PHS 398/SF424 instructions for Biographical Sketches and Other Support
information (including support for clinical trials activities). In the section entitled “Key Personnel” in
the PHS 398/SF424, it is imperative that applicants list all individuals participating in the scientific
execution of the main activities of the NCTN component in the format specified (i.e., name,
organization [their institutional affiliation], and role on the project), including those with no
requested salary support. Under “Role on the Project”, indicate how the individual will function with
regard to the Group.
A roster of Key Personnel should be included with each application. Key Personnel will usually
include the PI (and multiple PIs, if applicable), other significant scientific, technical and administrative
officers as well as major committee chairs and vice-chairs. Consultants should also be included if they
meet the definition of “Key Personnel." Applicants must ensure the list of Key Personnel is complete,
and may use as many continuation pages as necessary. Although information on "Other support" is
also required for all Key Personnel listed on all applications that are to receive grant awards;
information on “Other Support” should NOT be submitted with the application. Rather, NIH will
request complete and up to date "Other Support" information from applicants at an appropriate time
following peer review. The NIH’s scientific program and grants management staff will review this
information prior to award (see “Just-in-Time” information is this section of the Guidelines).
Please Note: All pages must be numbered sequentially within a submitted application. All
applications and proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should
not be used to provide information necessary to the review because reviewers are under no
obligation to view the internet sites. Furthermore, reviewers are cautioned that their
anonymity may be compromised when they directly access an internet site. The exception to
this is the URL for published manuscripts and abstracts via PubMed as only the public internet
references for these publications are accepted in the application.
The Network Group Operations Center applicant, in conjunction with its associated Network Group
Statistics and Data Management Center (SDMC), is required to submit a Common Budget Outline
(see Part 4: Appendices – Section IX) as part of its application.
Rationale for the Common Budget Outline: The Common Budget Outline was designed to provide
budget information in a standard format that allows the reviewers to understand how the total
Network Group budget is allocated among the various components of the Group to support its basic
functions and so the reviewers can compare budgets received across the NCTN Program.
Total Budget for a Network Group: The budget of a Network Group (i.e., Network Group Operations
Center and Network Group Statistics and Data Management Center) is dependent on accrual to the
trials led by the Network Group as well as the accrual to other Network Group trials. The estimated
total cost used to generate budgets for a Network Group as defined above should be based on
funding for (1) infrastructure support for the Network Group Operations Center and Network Group
Statistics and Data Management Center to develop, conduct and analyze NCTN clinical trials and
(2) costs to cover data collection and management and biospecimen collection associated with
patient enrollment to NCTN trials by member institution/sites.
Page 100 of 241