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/Management: Research costs include the time and
effort of the Operations Center staff that support the scientific leadership of
the Network Group in development of study proposals and study protocols as
well as the management of trials after activation (e.g., protocol amendment
processing).
� Administration: Research costs include the time and effort involved in the
overall management/administration of the Network Group's resources,
regulatory activities, quality assurance, study monitoring procedures, etc.
� Data and Safety Monitoring Boards (Required Funding in Application as
Separate Line Item as Funding is Restricted for this Purpose): Research costs
include the time and effort involved in the overall management/administration
by the Network Group Operations Center for the Data and Safety Monitoring
Board for the Network Group’s phase 3 and randomized phase 2 trials.
� Auditing (Required Funding in Application as Separate Line Item as Funding is
Restricted for this Purpose): Personnel costs and travel for the Network Group
Operations Center to support the Network Group auditing program.
� Tumor Bank Coordination (Required Funding in Application as Separate Line
Item as Funding is Restricted for this Purpose): Personnel costs to support
coordination of the activities of the Network Group Operations Center and the
associated Network Group SDMC with those of the Tumor Bank for the
Network Group (i.e., coordination support for linking biospecimens and clinical
data so there is an accurate inventory of available biospecimens and requests
for “banked” biospecimens for approved studies can be appropriately
supported).
b) Consultant Costs: Reasonable consultant costs are allowed if the consultant is
contributing in a substantial way to the conduct or development of Network
Group’s research strategy, although clear and quantifiable justification is required.
Most of a Network Group's consultant costs should appear in the Operations Center
budget. These costs include travel, per-diem and consultant fees, if applicable and
within institutional policy.
c) Equipment: Only those equipment items that are required to conduct Network
Group studies should be included. Justification should include percent of time used
for Network Group business as well as necessity for purchase. The amount of funds
requested should be based on percent of use.
d) Supplies: Research costs for appropriate supplies with quantitative justifications
based on actual use should be provided.
e) Travel: The importance of meetings to the achievements of any Network Group's
overall research strategy is obvious, as is the necessity to maintain careful control
over the size of this budget item. The budget for travel must be itemized and
justified. It should include the following:
� Trips by the Network Group's leadership and investigators on behalf of the Network
Group to the NCI and other national organizations where the results of Network Group
research are presented or where Network Group research strategies are to be
discussed;
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