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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 2: Submission of Competing New Applications Section I - Application Submission Instructions<br />

international Principal Investigator<br />

� OHRP assurance number (i.e., Federalwide Assurance number) for the non-US<br />

component<br />

F. Post Submission Materials<br />

Applicants are required to follow the instructions for post submission materials, as described in NOT-<br />

OD-10-115. Note: Because applications submitted in response to the Request for Applications<br />

(RFAs)/Funding Opportunity Announcements (FOAs) for all the key components of the <strong>NCTN</strong> <strong>Program</strong><br />

have only one due date, applicants may submit materials per the exceptions list in NOT-OD-10-115<br />

using the specified page limits (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-<br />

115.html).<br />

G. Eligibility Requirements<br />

Information on the eligibility requirements for applications (i.e., eligible organizations and eligible<br />

individuals) is provided in the Request for Applications (RFAs)/Funding Opportunity<br />

Announcements (FOAs) for all the key components of the <strong>NCTN</strong> <strong>Program</strong>. Applicants must meet<br />

these eligibility requirements in order for an award to be funded under the <strong>NCTN</strong> <strong>Program</strong>.<br />

In addition, there are eligibility requirements for organizations and individuals based on<br />

relationships across the six RFAs/FOAs of the <strong>Program</strong>. In particular, there cannot be overlap<br />

between the applicant Multiple PD(s)/PI(s) teams for awards under certain RFAs/FOAs and there<br />

cannot be overlap between applicant organizations for awards under certain RFAs/FOAs. This<br />

information is given in detail in the specific RFAs/FOAs. Examples are given below.<br />

� For example, there cannot be overlap in the applicant organization for a <strong>Network</strong> Group<br />

Operations Center award and the applicant organization for its associated <strong>Network</strong> Group<br />

Statistics and Data Management Center. This requirement is made in order to help insure<br />

independence of the <strong>Network</strong> Group Statistics and Data Management (SDMC) grant and is<br />

an important part of the review process for the SDMC applications under that FOA.<br />

� Another example is that there cannot be overlap between the applicant Multiple<br />

PD(s)/PI(s) team (as well as key personnel, if applicable) for a <strong>Network</strong> Group Operations<br />

Center award and the applicant Multiple PD(s)/PI(s) team for a Lead Academic<br />

Participating Site award in order to ensure independence of the Lead Academic Site with<br />

respect to providing scientific leadership and accrual across the entire <strong>NCTN</strong>. This latter<br />

requirement also extends to applicable key personnel between the 2 FOAs as well – for<br />

example, if there is only 1 PD/PI for a <strong>Network</strong> Group Operation Center, then a PD/PI from<br />

a Lead Academic Participating Site cannot fulfill the functions of the PD/PI on a <strong>Network</strong><br />

Group Operations Center in cases when the <strong>Network</strong> Group Operation Center PD/PI is not<br />

available (and vice versa).<br />

Applicants are encouraged to discuss any questions regarding fulfilling the eligibility requirements<br />

under the FOAs with the <strong>NCTN</strong> <strong>Program</strong> staff in a pre-application consultation call.<br />

Page 99 of 241

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