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
Academic Participating Site (and affiliates if the Lead Academic Participating
Site provides complete management services for the affiliates related to
enrollment of patients on NCTN trials) and in preparing the results of the
academic site’s research contribution to NCTN trials for publication. Research
costs may also include the time and effort involved in direct interactions of
investigators with patients due to the participation of the patient in the
research and the time and effort related to investigator intellectual activities
required for development, implementation, and conduct of clinical trials at the
academic site and affiliates.
NOTE: Funding for positions within the senior leadership of a Network Group
Operations Center (i.e., Executive Committee positions, Scientific and
Administrative Committee Chair/Co-Chair positions, Study Chair positions)
should be funded by the Network Group Operations Center via its grant to its
senior leadership team). The same is true for positions investigators at the
academic site hold in other key components of the NCTN Program – i.e.,
funding for those senior leadership positions should be funded via the key
component’s grant.
� Data management: Research costs include the time and effort involved in
accurate data collection and submission at the by the Lead Academic
Participating Site.
� Scientific Services: Research costs include the time and effort related to
providing specific services such as pathology and radiology at the Lead
Academic Participating Site.
� Administration: Research costs include the time and effort involved in
coordinating NCTN related research activities at the Lead Academic
Participating Site including regulatory activities, implementation of quality
assurance and study monitoring procedures and participation in Network
Groups’ onsite audit programs. If a Lead Academic Participating Site provides
complete management services for affiliates, its budget should include the
resources required to assure proper monitoring of the affiliates.
b) Consultant Costs: Consultant costs are not usually appropriate in this award, so
requests should be justified in detail. These costs include travel, per-diem, and
consultant fees, if applicable and within institutional policy.
c) Supplies, Equipment, and Other Costs: Research costs for appropriate supplies,
with quantitative justifications based on actual use, should be provided. Significant
equipment costs are unusual in this award, and such costs must be justified in
detail. The amount of funds requested for equipment should be based on the
percent of usage. Research costs due to other expenses include those associated
with communication with the various Network Groups’ offices, the costs of
compiling and mailing data and the costs of mailing or handling patient-related
specimens, forms, and materials (e.g., slides, X-ray films).
d) Travel: Travel for a reasonable number of the institution's participating
investigators, data managers, and nurses to attend the regular meetings of the
various Network Groups should be included in the Lead Academic Participating
Site’s budget. Attendance of investigators at meetings on behalf of the Network
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