NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Network Group Integrated Translational Science Centers
Multiple Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))Leadership Plan section of
the PHS 398). A rationale for choosing a multiple PD/PI approach should be described. The
governance and organizational structure of the leadership team for the Integrated
Translational Research Center should be described including communication plans, process
for making decisions and procedures for resolving conflicts. The roles and administrative,
technical, and statistical responsibilities for the Integrated Translational Research Center
should be delineated for the PD(s)/PI(s), including responsibilities for protection of
information on human subjects in clinical studies. If budget allocation is planned, the
distribution of resources to specific components of the Integrated Translational Research
Center and/or the individual PD(s)/PI(s) should be delineated in the Leadership Plan. In the
event of an award, the requested allocations may be reflected in a footnote of the Notice of
Award.
2.2 Sub-Section B. Translational Science Program (up to 12 pages)
This sub-section of the research plan should provide a more detailed description of the
specific technical expertise of the leadership team and the proposed strategies and
approaches that will be pursued for integrating translational research into the NCTN trials.
In particular, this sub-section should describe the disease areas and focus of the translation
research to be pursued and how the translational studies will be coordinated with collection
of associated clinical data and biospecimens. This sub-section should discuss how the aims
of the research program for integrating translational science studies into NCTN trials will
maximize the utility of NCTN clinical trial data and biospecimens and how the translational
science research program will benefit the research aims of the entire NCTN Program. This
sub-section should also describe how the translational science investigators will participate
in scientific meetings of the supporting Network Group Operations Center(s) and Network
Group Statistics and Data Management Center(s) and other activities of the NCTN Program
(e.g., NCI Scientific Steering Committees and associated task forces and working groups,
Clinical Trials Planning Meetings) as well as other NIH/NCI translational science programs
and initiatives.
2.3 Sub-section C. Pilot Studies and Collaborative Projects (up to 12 pages)
This sub-section of the research plan should provide a description of pilot studies to be
performed to enable collection of preliminary data required to effectively incorporate
specific translational science studies into late phase, definitive NCTN trials. This sub-section
should also describe plans for collaborating with other NCTN Program components as well as
other NCI-sponsored programs (e.g., SPOREs, NCI Cancer Centers) to facilitate hand-offs of
translational science discoveries and/or early phase clinical trial results into later phase,
NCTN trials. This sub-section should detail how institutional resources, especially laboratory
resources, and other independently funded resources will be leveraged to support the
development of translational research studies to be incorporated into NCTN trials and help
support any pilot studies.
2.4 Letter of Support from Network Group Operations Center(s) and Network Group SDMCs
In addition to general Letters of Support (e.g., Letter of Support from the institutions or
organizations supporting the Integrated Translations Science Center), the application should
also include Letters of Support from the Network Group Operations Center applicant
PD(s)/PI(s) and Network Group SDMC(s) supporting the Integrated Translations Science
Center senior leadership (PD(s)/PI(s)).
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. The Integrated Translational Science Support
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