NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
institutions/sites are described below. Note: “Special per case management” funding is not
part of the Network Group Operations Center budget as it will be provided periodically as
administrative supplements for specific trials, if needed, and “High-Performance
intervention per case Management” funding is not part of the budget for adult Network
Group Operations Centers as their member institutions/sites that qualify for that funding will
receive it either via direct grant funding in a Network Lead Academic Participating Site
award, CCOP/MB-CCOP award, or via a special initiative program administered by the NCI
Cancer Trials Support Unit (CTSU) at NCI/DCTD’s direction.
� Screening Per Case Management Funding: Funding to cover data management costs
for patients enrolled on a trial that require specific screening with informed consent as
part of the trial (e.g., investigational molecular test of their tumor) and who do not
subsequently undergo the study treatment/intervention and/or randomization because
of the screening results.
� Basic Intervention Per Case Management Funding: Funding to cover data management
costs for enrolled patients who undergo the study treatment/intervention and/or
randomization. Basic intervention funding is divided into therapeutic (treatment
intervention or pilot studies) or advanced imaging interventions. This base amount is
set at the same level for all treatment trials; however, the base amount for advanced
imaging trials may be different. This funding category also includes funding for average
follow-up per case data management for an NCTN trial (i.e., separate payments for
follow-up are not provided). Please note that the basic intervention per case cost
includes any screening performed (i.e., per case funding is provided for an enrolled
patient for either screening or intervention but not both). Likewise, intervention per
case management funding is provided at either the basic level or the high-performance
level, but not both – see the information on high-performance intervention per case
management funding below.
� Advanced Imaging Trial Per Case Management Funding: Funding to cover data
management and imaging costs for complex imaging used in advanced imaging trials
(above the base intervention per case amount described above) would be provided to
all NCTN participating sites by the Network Group Operations Center with a specialty
focus in this area that leads these trials (including providing the funding to other
Network Group Operations Centers for their members which participate in the trials) as
these studies are expected to be limited in number relative to the number of treatment
trials. This funding is provided on a trial by trial basis as approved by NCI/DCTD.
� Biospecimen Collection Per Case Management Funding: Funding to cover biospecimen
collection and any associated management costs for patients enrolled on study who
undergo the study treatment/intervention and/or randomization for trials with required
or optional biospecimen collections – this category of funding would not be expected to
be given in association with screening per case funding except in unusual circumstances.
This funding is provided on a trial by trial basis as approved by NCI/DCTD.
� Quality of Life Per Case Management Funding: Funding to cover data
collection/management costs associated with patient enrollment in quality of life substudies
incorporated into NCTN treatment or advanced imaging clinical trials is not
provided by NCI/DCTD except in special circumstances as described below.
“Quality of Life Per Case Management” funding is provided by the NCI Division of Cancer
Prevention (DCP) through the CCOP/MB-CCOP grants and to other member
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