NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget & Research Plan
Network Group SDMCs
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.
� All applications, regardless of the amount of direct costs requested for any one year,
should address a Data Sharing Plan. An example of 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
plans/policies are in compliance with NCI/NIH regulations and the Terms of the Award for
the applicable key component of the NCTN Program.
3. Appendix Material & Post Submission Materials
Information on the Appendix material that should be provided in the SDMC application, along
with information on the timing of submission of this material and the format in which it should
be provided is described in Part 2 – Section I.D of these Guidelines.
In addition to the information that can be included in the Appendix material described in that
section, copies of up to 3 protocol documents described/referenced in the narrative of Subsection
B - Statistical Analysis Program of the research plan as illustrating the proposed Network
Group Statistics and Data Management Center's robust statistical trial designs and statistical
analyses may be submitted in the Appendix. The applicant may not submit any other copies of
protocols being conducted or in development by the applicant in the Appendix
Information on post submission materials that may be provided for the Network Group SDMC
application is described in Part 2 – Section I.F of these Guidelines.
4. Just-in-Time Information
The following material must be submitted prior to the award of the Cooperative Agreement for
the Network Group SDMC.
4.1 Other Support for Key Personnel
NCI program staff will contact all applicants to be funded to request “Other Support” for Key
Personnel, including consortium/contract personnel. “Other Support” includes all financial
resources, whether federal, non-federal, commercial or institutional, available in direct
support of an individual's research endeavors, including but not limited to research grants,
Cooperative Agreements, contracts, and/or institutional awards. Training awards, prizes, or
gifts are not included. Percent effort should be specified as well as any support that is
pending. Information on other support assists the awarding NCI staff in the identification
and resolution of potential overlap of support. Overlap, whether scientific, budgetary, or
commitment of an individual's effort greater than 100 percent, is not permitted. The goals
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