NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 3: Submission Non-Competing Applications Section II – Research Plan & Budget
Budget commitments for the non-competing years are based upon the funding level for the
competing year. Increases or decreases in funding for any key component of the NCTN
Program may be made on the basis of changes in performance relative to that approved in
the competing application or in the previous year. The actual monies awarded are always, of
course, subject to the availability of funds. Thus, funding levels can be increased or reduced
because of increments or decrements in performance on the part of the awardee,
particularly with respect to funding restricted for use to cover data collection/management
and biospecimen collection related to enrollment of patients on clinical trials and their
follow-up and/or a change in the funds available to the government for distribution.
In particular, the Network Lead Academic Participating Sites will undergo assessment with
possible decrement in funding after 3-years of performance based on the awardee’s accrual
to NCTN trials.
B. Notification of International Involvement in Key Components of NCTN Program
The key component of the NCTN Program must alert the NCI/DCTD Senior Program Specialist for the
NCTN Program and to the Office of Grants Administration (OGA) when a non-competing application
involves any new international (non- U.S.) component, regardless of whether the component receives
federal funding under the awardee’s grant. In such cases, advance clearance from the U.S.
Department of State is required for each non- U.S. component prior to the start date of the award.
The information required by U.S. Department of State is listed below (this information should also
include all non- U.S. subcontracts).
� Estimated annual Total Cost dollar award for the non- U.S. component
� Name, organization, city, and country of the International (non- U.S.) Principal or
Collaborating Investigator(s)
� Biosketch and Curriculum Vitae (CV) for both the domestic Principal Investigator and the
international Principal Investigator
� OHRP assurance number (i.e., Federalwide Assurance number) for the non-US component
In addition, for international sites collaborating with a U.S. Network Group or Canadian Collaborating
Clinical Trials Network on trials sponsored under the NCTN Program (regardless of whether the U.S.
or Canadian organization or the international organization is leading the trial and regardless of
whether any funding is being provided), U.S. Department of State clearance is required for the non-
U.S. country as clinical data is being passed between the U.S./Canadian organization supported under
the NCTN Program and the other country.
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