NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Network Lead Academic Participating Sites
clinical trial network organizations (either committees from the former NCI Clinical Trials
Cooperative Group Program or an equivalent non-profit clinical trial network organization)
as well as the clinical productivity of the academic center should be summarized in tables.
Use of template Tables #1, #2, #3, and #4 as described in Part 4 - Appendices – Section II.A.
of these Guidelines for the NCTN Program is highly recommended and may be included in
the Resources section of the application.
2.3 Sub-section C. Site Accrual Program (up to 12 pages)
This sub-section should consist of a well-defined plan for robust accrual to NCTN trials across
the Network, including accrual to rare cancers, by the applicant's academic institution/site
and any affiliate site(s) for which it will provide complete management services for patients
enrolled on NCTN trials.
This sub-section of the research plan should describe both the accrual potential of the
academic institution/site and the operational efficiency of trial activation and conduct by the
academic center (including the timeliness of data submission and auditing results as well as
how quickly it activates clinical treatment trials). This information can be provided from
participation in the former NCI Clinical Trials Cooperative Group Program or an equivalent
non-profit clinical trials network organization).
Use of template Tables #5, #6, #7, and #8 as described in Part 4 - Appendices – Section II.A.
of these Guidelines for the NCTN Program is highly recommended and may be included in
the Resources section of the application.
2.4 Letters of Support from Network Group Operations Centers and Affiliates
The Lead Academic Participating Site application should also include letters of support from
potential Network Group Operation Center applicants to which the academic center
belongs. These letters of support should be for investigators at the academic center that are
members of the Network Group scientific research committees and/or senior leadership that
will also be part of the senior leadership team at the Lead Academic Site (or a PD/PI on the
application if the institution employs the multiple PD/PI option for the grant application). If
the Lead Academic Site application includes affiliates for which the academic center
provides complete management services, Letters of Support from the affiliates should be
included in the application since the affiliates will need to acknowledge in the letters that
they agree to receive NCI funding for data management on all NCTN trials they participate
in via this grant (i.e., an affiliate cannot be an affiliate of another institution for purposes
of its NCTN program participation) and thus support their inclusion in the application.
2.5 Protection of Human Subjects
Applicants should consult the PHS 398/SF424 regarding general instructions on what types
of information should be included in the application regarding human subjects research,
including the protection of human subjects. Information on the targeted/planned
enrollment table for minorities and members of both genders (as well as children, if
applicable), should be based on accrual summarized across all diseases for planned project
period in the competing new application (Type 1), not on a study or disease-specific basis.
The Network Lead Academic Participating Site application must address the inclusion of women and
minorities and inclusion of children in the clinical research it participates in as required per NIH/NCI
Policy. Information on the policies for inclusion of women and minorities is available at:
http://grants.nih.gov/grants/funding/women_min/women_min.htm
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
Information on the policies for inclusion of children is available at:
http://grants.nih.gov/grants/funding/children/children.htm
http://www.nih.gov/grants/guide/notice-files/not98-024.html
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