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
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 Lead Academic Participating Site will follow the Resource Sharing Plans of the
associated Network Group Operations Center(s) it works with, the proposed Network Lead
Academic Participating Site should indicate in its application that it is bound by these plans (i.e.,
the resource sharing plans that may have been submitted by the associated Network Group
Operations Centers of which the applicant is a member). An example for a Data Sharing Plan for
Network Group Operations Centers and associated Network Group SDMCs 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 Network Lead Academic
Participating Site 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. Information on post submission materials that may be provided for the Network
Lead Academic Participating Site 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 Lead Academic Participating Site.
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
in identifying and eliminating such overlap are to ensure that: (1) sufficient and appropriate
levels of effort are committed to the project, (2) there is no duplication of funding for
scientific aims, specific budgetary items, or an individual's level of effort, and (3) only funds
necessary to the conduct of the approved project are included in the award.
4.2 Training on Human Subjects Protection for Key Personnel
As part of Just-In-Time information, the Network Lead Academic Participating Site should
also submit a roster of Key Personnel and indicate the type of training program on human
subjects protection completed by each person listed. The NIH policy on Human Subjects
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