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
Support System (RSS) and the Oncology Patient Enrollment Network (OPEN) for all
NCTN clinical trials.
The Network Radiotherapy & Imaging Core Services Centers applicant should also describe
its capacity to provide core services to NCTN trials that result from collaborations between
the Network Groups and other NCI-supported programs and investigators. The Network
Radiotherapy & Imaging Core Services Centers applicant should also be able to describe
plans for collaborations with other NCI-sponsored programs and investigators (e.g., SPOREs,
Cancer Centers, R01/P01 investigators, NCI/DCTD early phase clinical trials programs) to
augment and enhance the core services provided by the Centers for NCTN trials as well as
how to collaborate with other organizations providing these types of services to enhance
services and provide best practices and/or standards for selected assessments of
radiotherapy and advanced imaging techniques.
In addition, the Network Radiotherapy & Imaging Core Services Centers applicant should
describe its plans for participation in the collective management of the Network including
participation in appropriate NCTN Program activities and initiatives.
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 Network Radiotherapy and Imaging Core
Services application must address the inclusion of women and minorities and inclusion of
children in its clinical research program support, if appropriate, 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
2.6 Resource Sharing Plans
Applicants are required to comply with the instructions for the Resource Sharing Plans (Data
Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as
provided in the PHS 398 Application Guide with the following modifications:
� Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms if
applicable, and Genome Wide Association Studies (GWAS) are expected in this
application. Since it is expected that the Network Radiotherapy and Imaging Core
Services Centers will follow the Resource Sharing Plans of the associated Network Group
Operations Center(s) it works with, the proposed Radiotherapy and Imaging Core
Services Centers should submit a Resource Sharing Plan in its application that indicates
that it understands and is bound by these plans. An example for a Data Sharing Plan for
Network Group Operations Centers and associated Network Group Statistics and Data
Management Centers for the NCTN Program is provided in Part 4 – Appendices –
Section VII in these Guidelines.
The Data Sharing Plan and other resource plans (or rationale for not providing sharing
certain resources) should be provided in the research application; however, prior to funding
of an award, all resource sharing plans/policies will also need to be reviewed and approved
by NCI/DCTD program staff prior to funding any award in order to ensure that the
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