NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
Group may make a case for reimbursement of patient care costs associated with the
particular research element as an administrative supplement. The justification should be
presented at the level of the Network Group Chair(s) to the Lead NCTN Program Director
with a specific request from each institution based upon likely accrual to the specific study.
This request would need to be approved/funded by NCI/DCTD for the specific trial prior to
activation of the study. Alternatively, the Network Group could seek other sources of
funding for these costs (e.g., company collaborators, other NIH/NCI grant funding, charitable
foundation funding).
In the case such funding was approved by NCI for a specific NCTN trial, it would be expected
that the Network Group Operations Centers would provide this funding as per case “special
per case management” funding to their respective member institutions/sites that enrolled
patients on the trial and credited the Network Group Operations Center with the accrual. At
its discretion, for the Lead Academic Participating Sites, the NCI/DCTD could decide to
provide such funding directly to Lead Academic Participating Sites (and the affiliates included
in its award) that are enrolling patients on the trial via an administrative supplement to their
grants if it was expected that enrollment to the trial would be concentrated primarily at
these sites. NCI/DCTD would specify, at the time such funding was approved for an NCTN
trial, how the funding would be provided to the Lead Academic Participating Sites awardees.
Rationale for patient care cost policy: This policy is based on the observation that Network
Group NCTN trials always involve treatment or imaging that is administered with therapeutic
intent to patients who require medical care, and always involves therapy that is either
considered standard medical treatment or can reasonably be expected to be superior to it.
Therefore, all costs associated with standard patient care are legitimately borne by third
party carriers.
1.4 Per Case Management Funding - Adult Network Group Operations Center Budgets
(Restricted)
This category of funding must be included in the budget of the Network Group Operations
Center and must be restricted for this purpose. The Network Group Operations Center’s
budget for per case data collection and management and biospecimen collection funding
(also called “per case management” funding) should be estimated based on accrual
projections for patient enrollment by its member institutions/sites to all NCTN trials that the
institutions/sites credit to the Network Group Operations Center. This funding amount is
based on the amounts and funding algorithm specified in Part 4: Appendices – Section IV
(Total Cost Figures for Budget Preparation) using the definitions provided below for the
various categories of “per case management” funding.
The amount for these funding categories as specified in Part 4: Appendices – Section IV
reflect the total cost that must be provided to the participating site that is a member of
the Network Group Operations Office and which does not receive its funding via a grant as
a Lead Academic Participating Site, COOP, or MB-CCOP, or as a pediatric site via the Pediatric
Network Group’s grant. These amounts are based on the “category” of funding as defined
below and are set at the same level across the entire NCTN regardless of the Network Group
Operations Center leading the trial. Only these amounts should be used in creating the
application budget. These amounts are paid by the Network Group Operations Center based
on accrual to any NCTN trial for which the member credits the Network Group Operations
Center regardless of which Network Group is leading the trial.
The various categories of NCI/DCTD supported “per case management” funding that should
be included in an adult Network Group Operations Center budget for its member
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