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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 2: Submission of New/Competing Application Section III.B.2.2 – Review Criteria<br />

<strong>Network</strong> Group SDMC<br />

2.2 <strong>Network</strong> Group Statistics and Data Management Center Review Criteria<br />

Only the review criteria described below (and the Additional Review Criteria – Overall listed<br />

in Part 2 – Section III.B.3.) will be considered in the review process. As part of the NIH<br />

mission, all applications submitted to the NIH in support of biomedical and behavioral<br />

research are evaluated for scientific and technical merit through the NIH peer review<br />

system.<br />

2.2.1 Overall Impact - Overall<br />

Reviewers will provide an overall impact/priority score to reflect their assessment of<br />

the likelihood for the proposed <strong>Network</strong> Group Statistics and Data Management<br />

Center to exert a sustained, powerful influence on the research field(s) involved, in<br />

consideration of the following review criteria and additional review criteria (as<br />

applicable for the proposed <strong>Network</strong> Group Statistics and Data Management Center).<br />

2.2.2 Scored Review Criteria – Overall<br />

Reviewers will consider each of the review criteria below in the determination of<br />

scientific merit, and give a separate score for each. An application does not need to be<br />

strong in all categories to be judged likely to have major scientific impact. For<br />

example, a proposed <strong>Network</strong> Group Statistics and Data Management Center that by<br />

its nature is not innovative may be essential to advance a field.<br />

Significance<br />

Does the proposed <strong>Network</strong> Group Statistics and Data Management Center help<br />

address an important problem or a critical barrier to progress in the field? If the aims<br />

of the proposed <strong>Network</strong> Group Statistics and Data Management Center are achieved,<br />

how will scientific knowledge, technical capability, and/or clinical practice be<br />

improved? How will successful completion of the aims change the concepts,<br />

methods, technologies, treatments, services, or preventative interventions that drive<br />

this field?<br />

Investigator(s)<br />

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed<br />

<strong>Network</strong> Group Statistics and Data Management Center's Statistics <strong>Program</strong> and Data<br />

Management <strong>Program</strong> as well as its plans for collaborations and collective<br />

management? If Early Stage Investigators or New Investigators, or in the early stages<br />

of independent careers, do they have appropriate experience and training? If<br />

established, have they demonstrated an ongoing record of accomplishments that<br />

have advanced their field(s)? Given that all <strong>NCTN</strong> <strong>Program</strong> research projects/trials are<br />

collaborative, and regardless of whether the applicants choose to use the multi-PD/PI<br />

option, do the investigators have complementary and integrated expertise; are their<br />

leadership approach, governance and organizational structure appropriate for the<br />

clinical research that the proposed <strong>Network</strong> Group Statistics and Data Management<br />

Center helps conduct and manage?<br />

Innovation<br />

Does the application challenge and seek to shift current research or clinical practice<br />

paradigms by utilizing novel theoretical concepts, approaches or methodologies,<br />

instrumentation, or interventions? Are the concepts, approaches or methodologies,<br />

instrumentation, or interventions novel to one field of research or novel in a broad<br />

sense? Is a refinement, improvement, or new application of theoretical concepts,<br />

approaches or methodologies, instrumentation, or interventions proposed?<br />

Page 161 of 241

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