NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
protocol development). A specific budget page covering the Network Group's quality
assurance and study monitoring activities, onsite audit program, and must be included.
Funds for correlative science research and/or reference laboratories are not supported
under the NCTN Program and should not be included in the application. Funding for
integral and integrated laboratory and/or biomarker studies for NCTN trials can be covered
by BIQSFP applications (see information on the BIQSFP at: http://biqsfp.cancer.gov/) as well
as through other sources of funding (e.g., R01/P01 grants, industry and charitable support),
and potentially through administrative supplements for specific trials under the NCTN
Cooperative Agreement.
The following budget guidelines apply specifically to the Network Group Operations Center
budget. The categories listed below (with the exception of “Mechanisms for Per Case Data
Management Funding”) refer to those contained in the section of the PHS 398/SF424
pertaining to the detailed budget for initial budget period. NOTE: Specific job descriptions
and qualifications for funded personnel (administrative as well as scientific leadership)
should be covered in this budget section and not repeated in the research plan narrative.
a) Personnel: A staffing plan for the Network Group Operations Center, including
position descriptions and qualifications should be provided. Precise justification for
the amount of effort requested for each position is essential, including the
following:
� Scientific Leadership: Research costs include the time and effort involved in
developing the Network Group’s research strategy and its repertoire of
trials/protocols as well as the trial monitoring, analysis of results, and
publication of those results of Network Group research in peer reviewed
journals. These costs also include funding for scientific research and
administrative committee chairs and/or vice-chair or co-chair positions as well
as study chairs, if applicable.
� Scientific Services: Research costs include the time and effort involved in
providing scientific services such as scientific review (toxicity review, pathology
review, surgical review) specific to the research goals of a Network Group study
(i.e., not associated with conventional patient care or for educational
purposes). As noted above, correlative science research outside of
biospecimen and/or special image collection approved for specific trials is not
funded under the NCTN. Funding for integral and integrated laboratory and/or
biomarker assessment for NCTN trials can be covered by BIQSFP applications or
other funding sources as described in Section 1.1 above.
Network Group Operations Center budgets also should not include scientific
services related to development of innovations in advanced imaging and
radiotherapy treatments unless it is a specific, essential component of the
Network Group’s overall research strategy. It is anticipated that services for
developmental work in these areas would only be funded in 1 Network Group
and would need to be requested as a specific budget item in the appropriate
categories in the PHS 398 budget pages and as a specific budget line item in the
Common Budget Outline. General quality assurance for imaging and
radiotherapy for clinical trials should be part of the Network Radiotherapy and
Imaging Core Services Centers.
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