NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section III – General Management & Network Operating/Funding Principles
48 days for initial review) or if the institution/site can demonstrate other exceptional circumstances that
preclude it from using the NCI CIRB. This requirement does not apply to international (non-U.S.)
institutions/sites participating in NCTN trials (including member institutions/sites of the Canadian
Collaborating Clinical Trials Network), given different regulatory requirements/procedures covering human
subjects protection in other countries.
4. Trial Proposals Originating From Outside the Network Groups
Network Groups will provide trial operations, data management and statistical support for trials originating
from within the Network but also for approved, multi-center phase 2 and 3 trials originating outside the
Network that are prioritized for development by the disease-specific Scientific Steering Committee and
approved for development by NCI/DCTD as part of the NCTN Program. Network Radiotherapy and Imaging
Core Services Centers will also provide core services support for such trials as well as for other approved
collaborations with NCI-supported trials (e.g., NCI-sponsored early phase clinical trials) under the NCTN
Program. In special circumstances, administrative supplements may be provided to Network Groups to
help support trial conduct and integral/integrated translational science based on a direct solicitation for a
trial from NCI/DCTD, particularly for clinical trials in rare cancers. As the primary vehicle for definitive,
large-scale, controlled clinical treatment and advanced imaging trials sponsored by the NCI, the Network
Groups should strive to provide a transparent, user-friendly operation for all NCI-sponsored investigators
who have trial concepts approved by the NCI Scientific Steering Committees.
D. Network Funding Principles
In keeping with the need for collaboration across the NCTN, funding for data collection and management and
for biospecimen collection is provided in a consistent manner for institutions/sites that enroll patients on NCTN
trials. The funding to cover the costs for these activities is provided on a “per enrolled patient” basis (“per case
management funding”) based on a total cost figure. The funding is provided directly by the NCI/DCTD to
Network Lead Academic Participating Sites, by NCI/DCP to CCOPs and MB-CCOPs, and through Network Group
Operations Centers for their member institutions/sites which are not Lead Academic Participating Sites, CCOPs,
or MB-CCOPS.
Any separate, non-NCI/DCTD funding (i.e., funding not provided under the Cooperative Agreements of the
NCTN Program) dispensed by a Network Group to cover costs associated with patient enrollment on NCTN
trials that it leads must be provided to all qualified institutions/sites that participate in its NCTN trials
regardless of which Network Group the enrolling institution belongs to and/or credits with the patient
accrual. This principle is considered an essential feature of the NCTN Program and the Terms and Conditions
of Award as it is fundamental to ensure fairness for work performed across the Network.
The principles covering “per case management funding” are outlined below, including providing “highperformance
per case management funding” to cover the additional data collection, management, and followup
costs/workloads at institutions (with acceptable audit standings) that enroll a large number of patients.
Eligibility for such “high-performance” funding is based on specific thresholds set by NCI/DCTD (with specific
thresholds for Lead Academic Participating Sites, CCOPs and MB-CCOPs, pediatric institutions/sites, and other
member institutions/sites of the Network Groups).
1. Grant Funding for Key Components of the NCTN Program
The allowable costs under the Cooperative Agreements for each of the key components of the NCTN
Program are described under the budget section of the application process for new applications in Part 2 of
these Guidelines. In general, the funds can support costs associated with personnel (e.g., operational staff,
scientific and administrative committees leaders, principal investigators for specific trials), travel,
appropriate equipment, and other operational costs related to the conduct of clinical trials; however, costs
for patient recruitment, patient care, laboratory tests, and reference laboratory research are not allowed
under the grant funding for the NCTN Program, unless approved by the Lead NCTN Program Director and
Associate Director, CTEP for exceptional circumstances related to a specific trial. Funding for research
laboratory tests must be supported from other resources, including BIQSFP funds, commercial and
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