NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Network RT & Imaging Core Services Centers
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 supporting the Network Radiotherapy and Imaging Core Services Centers, and
Multiple Program Director/Principal Investigator (PD/PI) Leadership Plan, remain unmodified and
must be completed following standard instructions.
2.1 Sub-section A. Network Radiotherapy and Imaging Core Services Centers Overview (up to
12 pages)
This sub-section of the research plan should give an overview of the scientific and technical
expertise provided by the Core Service Centers’ staff for radiotherapy and imaging, including
its senior leadership team. A brief overview of the facilities of the Cores should be
presented. This sub-section of the research plan should also give a detailed description of
the organizational structure and governance policy for the core centers for radiotherapy and
imaging, especially if multiple PD(s)/PI(s) are involved. This sub-section should describe how
the Cores will interact with various Network Group Operations Centers and associated
SDMCs and the Cores' plan for how to have these organizations represented on the senior
leadership team to enhance coordination of services for all NCTN trials.
For applications designating multiple PD(s)/PI(s), a leadership plan related to the multiple
PD/PI designation must be included in the appropriate section of the application (i.e.,
Multiple Program Director/Principal Investigator (PD/PI) 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 Core Services
Centers 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 Core Services Centers 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 Core
Services Centers 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.
This sub-section should also describe how the Cores will prioritize services for NCTN trials as
well as how they will ensure that their input is incorporated so as to ensure operational
efficiency in study development and completion of studies as well as how the applicant will
comply with NCI/NIH and other federal regulations regarding study monitoring and clinical
research (e.g., human subjects protection especially with respect to the confidentiality of
patient data and coordination with the Network Groups to provide data for their onsite
auditing programs) should be addressed in this sub-section.
In addition, the application should describe how the activities of the radiotherapy core will
be coordinated with the imaging core, especially with respect to IT services and image
management. This sub-section should also describe key collaborations between the 2 Cores
as well as between Cores and the Network Groups, especially with respect to development
of standards and harmonization of processes and data collection.
The applicant's key standard operating procedures for the conduct of clinical trials related to
the following should be provided in the Resource section of the application:
� Key Standard Operating Procedures for Radiotherapy and Imaging Quality
Assurance, Image Data Management, and Credentialing
� Procedures to Ensure Security and Confidentiality of Patient Data
� Conflict of Interest Policy
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