NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Network Lead Academic Participating Sites
Groups, or at special (i.e., non-routine) meetings of committees of the various
Network Groups, should generally be funded through the respective Network
Group Operations Center or Network Group Statistics and Data Management
Center, rather than through this award.
e) Patient care costs: NCI will not support costs associated with routine patient care.
Only in the most unusual circumstances would a Network Group clinical trial require
interventions beyond those considered appropriate for the care of cancer patients.
In those circumstances, a Network 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 the PD(s)/PI(s) and grantee institution of each applicable Network Group
Operations Center 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. 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 intervention” management funding to
their respective member institutions/sites that enrolled patients on the trial and
credited the Network Group Operations Center with the accrual. Alternatively, the
NCI/DCTD could decide to provide such funding directly to Lead Academic
Participating Sites enrolling patients on the trial via an administrative supplement if
it was expected that enrollment to the trial would be concentrated primarily at
these sites. NCT/DCTD would specify, at the time such funding was approved, how
the funding would be provided to the Lead Academic Participating Sites.
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.
f) Consortium/Contractual costs: Separate budget pages with detailed justification of
all requested items should be submitted for each consortium agreement and
applicable indirect costs should be included.
g) Consortium/ Contractual Arrangements: Consortium arrangements and all other
contractual arrangements, including mechanisms for reimbursement for
administration management/data management for patient accrual, must be
formalized in writing in accordance with applicable NIH Grants Policy requirements
available at: http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch15.htm. A
statement that the applicant organization and the collaborating organization have
established or are prepared to establish a formalized agreement that will ensure
compliance with all pertinent NCI, NIH, DHHS, and federal regulations and policies
must be included in the application. Also include all pertinent biographical sketches
and a list of all other support for all relevant consortium participants.
1.3 Rationale for Budget Policy
Lead Academic Participating Sites considered “high performance” sites and receive a higher
rate for per case data management funding because of the institutional burden of the large
number of patients accrued and the efforts of the academic center’s investigators in the
scientific development of trials across the NCTN. Thus, the academic site performs two
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