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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 2: Submission of New/Competing Application Section II –Budget & Research Plan<br />

<strong>Network</strong> Group Integrated Translational Science Centers<br />

application must address the inclusion of women and minorities and inclusion of children in<br />

its clinical research as required per NIH/<strong>NCI</strong> Policy. Information on the policies for inclusion<br />

of women and minorities is available at:<br />

http://grants.nih.gov/grants/funding/women_min/women_min.htm<br />

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html<br />

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm<br />

Information on the policies for inclusion of children is available at:<br />

http://grants.nih.gov/grants/funding/children/children.htm<br />

http://www.nih.gov/grants/guide/notice-files/not98-024.html<br />

2.6 Resource Sharing Plans<br />

Applicants are required to comply with the instructions for the Resource Sharing Plans (Data<br />

Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as<br />

provided in the PHS 398 Application Guide with the following modifications:<br />

� Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms if<br />

applicable, and Genome Wide Association Studies (GWAS) are expected in this<br />

application. Since it is expected that the <strong>Network</strong> Group Integrated Translational<br />

Science Center will follow the Resource Sharing Plans of the associated <strong>Network</strong> Group<br />

Operations Center(s) it works with, the proposed <strong>Network</strong> Group Integrated<br />

Translational Science Center should indicate in its application that it is bound by these<br />

plans (i.e., the resource sharing plans that may have been submitted by the associated<br />

<strong>Network</strong> Group Operations Centers which the applicant will work with). An example for<br />

a Data Sharing Plan for <strong>Network</strong> Group Operations Centers and associated <strong>Network</strong><br />

Group Statistics and Data Management Centers for the <strong>NCTN</strong> <strong>Program</strong> is provided in<br />

Part 4 – Appendices – Section VII in these <strong>Guidelines</strong>.<br />

The Data Sharing Plan and other resource plans (or rationale for not providing sharing<br />

certain resources) should be provided in the research application; however, prior to funding<br />

of an award, all resource sharing plans/policies will also need to be reviewed and approved<br />

by <strong>NCI</strong>/DCTD program staff prior to funding any award in order to ensure that the<br />

plans/policies are in compliance with <strong>NCI</strong>/NIH regulations and the Terms of the Award for<br />

the applicable key component of the <strong>NCTN</strong> <strong>Program</strong>.<br />

3. Appendix Material & Post Submission Materials<br />

Information on the Appendix material that should be provided in the Integrated Translational<br />

Science Center application, along with information on the timing of submission of this material<br />

and the format in which it should be provided is described in Part 2 – Section I.D. of these<br />

<strong>Guidelines</strong>. Information on post submission materials that may be provided for the <strong>Network</strong><br />

Group Operations Center application is described in Part 2 – Section I.F of these <strong>Guidelines</strong>.<br />

4. Just-in-Time Information<br />

The following material must be submitted prior to the award of the Cooperative Agreement to<br />

the <strong>Network</strong> Group Integrated Translational Science Center applicants.<br />

4.1 Other Support for Key Personnel<br />

<strong>NCI</strong> program staff will contact all applicants to be funded to request “Other Support” for Key<br />

Personnel, including consortium/contract personnel. “Other Support” includes all financial<br />

resources, whether federal, non-federal, commercial or institutional, available in direct<br />

support of an individual's research endeavors, including but not limited to research grants,<br />

Cooperative Agreements, contracts, and/or institutional awards. Training awards, prizes, or<br />

gifts are not included. Percent effort should be specified as well as any support that is<br />

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