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
coordinated research team and to work efficiently and expeditiously with the supporting
Network Group Operations Center(s) and Network Group Statistics and Data Management
Center(s) to enhance the research goals of the NCTN Program and to enroll NCTN trials
across the Network. This sub-section should also describe the institution’s conflict of
interest policy with respect to this award and the policies and procedures in place for
ensuring compliance with all federal/DHHS/NIH/NCI policies and regulations regarding the
use of data from clinical trials involving human subjects, including regulations concerning the
confidentiality, integrity, and security of patient data.
For applications designating multiple PD(s)/PI(s), a leadership plan related to the multiple
PD(s)/PI(s) designation must be included in the appropriate section of the application (i.e.,
Multiple Director(s)/Principal Investigator(s) (PD(s)/PI(s)) Leadership Plan section of the PHS
398). A rationale for choosing a multiple PD(s)/PI(s) approach should be described. The
governance and organizational structure of the leadership team for the Operations Center
should be described including communication plans, process for making decisions on
scientific direction, and procedures for resolving conflicts. The roles and administrative,
technical, and scientific responsibilities for the Lead Academic Participating Site should be
delineated for the PD(s)/PI(s), including responsibilities for human subjects in clinical studies.
If budget allocation is planned, the distribution of resources to specific components of the
Lead Academic Participating Site 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. Clinical Trial Program (up to 12 pages)
This functional component should consist of a well-defined plan by the applicant for its
participation in scientific leadership for NCTN trials across the Network as well as for
coordination activities at the main academic institution/site regarding participation in the
NCTN Program, including the use of the NCI Central Institutional Review Board and other
NCTN Program initiatives and activities.
This sub-section should concisely describe the academic centers scientific leadership in
development of NCTN clinical trials and in the scientific activities of the NCTN, including
activities with all the Network Groups to which the academic center belongs as well as
activities related to NCI initiatives for the NCTN Program such as participating as members
on the NCI CIRB and the NCI Scientific Steering Committees. This sub-section should also
describe how institutional activities related to the NCTN across various disciplines and
departments at the institution are coordinated and how activities and responsibilities will be
carried out among the multiple PD(s)/PI(s), if applicable. The academic center should
address how it would select NCTN clinical trials to activate at the center and how it would
mesh clinical research activities at the center with that of the NCTN Program. In particular,
application should clearly describe how funding associated with patient enrollment and
clinical data collection and management will be distributed to the various disciplines and
clinical departments involved in the conduct of NCTN trials at the center.
The academic center should highlight in this narrative section its most important
achievements over prior project period in activities that show its potential for achievement
in the NCTN (these achievements can include those from the former NCI Clinical Trials
Cooperative Group Program or an equivalent non-profit clinical trial network organization).
In addition, the academic center should also describe how it mentors junior investigators in
clinical trial research.
The academic center’s senior leadership team, including representation of its investigators
on executive/advisory committees as well as on scientific and administrative committees for
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