NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III – Other NCTN Review Criteria & Info
4.1 Applications from Foreign Organizations
Applications from foreign organizations are not permitted for the following key components
of the NCTN Program:
� Network Group Operations Centers
� Network Group Statistics and Data Management Centers
� Network Group Integrated Translational Science Support Center
� Network Lead Academic Participating Sites
� Network Radiotherapy and Imaging Core Services Centers
4.2 Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1)
the Select Agent(s) to be used in the proposed research, 2) the registration status of all
entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety,
biocontainment, and security of the Select Agent(s).
4.3 Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2)
Sharing Model Organisms, if applicable, and 3) Genome Wide Association Studies (GWAS).
Applicants should review the information in the associated Funding Opportunity
Announcement for the key component of the NCTN Program as to what needs to be
submitted with respect to Resource Sharing Plans. However, final approval of all Resource
Sharing Plans is determined by NCI/DCTD staff prior to the start date of the award:.
4.4 Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research.
C. Review Scoring
All scored components of the applications under the NCTN Program (i.e., the General Core Review
Criteria Category and the Scored Additional Specific Review Criteria Categories) are scored
numerically using the 9-point scale (1 =exceptional; 9=poor) scoring scale. Any of these components
can be rated Not Recommended for Further Consideration (NRFC) if the component lacks significant
and substantial merit.
For each discussed application, a final numerical impact/priority score from 1 (exceptional) to 9
(poor) will be given by each eligible SEP member (those without conflicts of interest). Each reviewer’s
overall impact/priority score will reflect his/her evaluation of the likelihood that the overall
application will have a sustained powerful impact clinical research conducted by the NCTN.
Reviewers will focus on the scored categories, excluding any components not recommended for
further consideration, in assigning the final overall impact/priority score. However, inclusion of
components of poor quality will be considered evidence of poor judgment by the Principal
Investigator(s) for the application. Reviewers do not have the option to select only the better
components of an application to improve the overall impact/priority score.
If an application has many major weaknesses and therefore is likely to have low impact relative to all
other applications normally received by the NCI, the review panel may choose to expedite the
discussion/ or to not discuss the application. An entire application can be not recommended for
further consideration if it lacks significant and substantial merit or presents serious ethical problems
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