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
2.2 Sub-section B. Radiotherapy Core Services Center (up to 12 pages)
This sub-section should consist of a well-defined plan outlining the general approaches to be
used and the specific services that will be provided by the radiotherapy core for NCTN trials,
including the policies and procedures for the types of quality assurance & credentialing
provided by the core. A detailed description of the special facilities and equipment used by
the core should also be provided. Key accomplishments related to services provided for
clinical trials should be highlighted in this sub-section.
NOTE: Narrative information may be supplemented by an optional table that details the
applicant’s track record in providing specific clinical trials with core services. Appropriate
summary documentation of the applicant team’s track record over the past 5 to 6 years may
be summarized in tables. Use of template Table #1 as described in Part 4 - Appendices –
Section II.D. 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. Imaging Core Services Center (up to 12 pages)
This sub-section should consist of a well-defined plan outlining the general approaches to be
used and the specific services that will be provided by the imaging core for NCTN trials,
including the policies and procedures for the types of quality assurance, credentialing, and
imaging data management provided by the core. In the description, include plans for
participation in the development of NEMA DICOM-RT standards (http://medical.nema.org/)
and in support of trials which merge imaging from different platforms such as FDG PET, CT,
MRI, and other platforms. Also, provide a detailed description of the special facilities and
equipment used by the Core team and highlight key accomplishments related to the services
provided for clinical trials.
NOTE: Narrative information may be supplemented by an optional table that details the
applicant’s track record in providing specific clinical trials with core services. Appropriate
summary documentation of the applicant team’s track record over the past 5 to 6 years may
be summarized in tables. Use of template Table #2 as described in Part 4 - Appendices –
Section II.D. of these Guidelines for the NCTN Program is highly recommended and may be
included in the Resources section of the application.
2.4 Sub-section D. Program for Collaborations and Participation in Collective Management (up
to 12 pages)
This sub-section should consist of a well-defined plan for key collaborations between the 2
Cores, especially with respect to development of standards and harmonization of processes
and data collection. The Cores should also describe how they plan to work with Network
Group Operations Centers and associated Statistics and Data Management Centers with
respect to development of standards and harmonization of processes and data collection for
NCTN trials. This description should also explain the following aspects:
� The applicant’s capacity for interoperability with the common data management
system (CDMS) of the NCTN Program to collect clinical trial data and link
information to clinical data collected by other key components of the NCTN
Program (i.e., Network Group Operations Centers and associated Network Group
Statistics and Data Management Centers, and
� The applicant’s ability and plans to work with the NCTN Program tools and services
employed for regulatory support and patients enrollment (i.e., the Regulatory
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