NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
Membership Roster: The Network Group Operations Center is responsible for having a comprehensive
and consolidated membership roster of all its sites and associated investigators and research staff and
for maintaining the roster for both auditing and financial management purposes with “real-time” status
of all members within the Regulatory Support System (RSS) of the NCI Cancer Trials Support Unit
(CTSU). All member institutions/sites must have appropriate and accurate NCI institutional codes
approved by NCI. Institutions/sites are assigned to one of the following mutually exclusive categories
across the entire Network for the NCTN Program for purposes of NCI/DCTD funding and crediting of
accrual: (1) Lead Academic Participating Site (academic center and its essential components); (2)
Affiliates included in a Lead Academic Site award (because they are completely managed by the Lead
Academic Participating Site); (3) CCOP; (4) MB-CCOP; (5) Pediatric site; and (6) other Network Group
member institutions/sites. For example, a site that is a CCOP has that designation across the NCTN
Program regardless of the number of Network Groups to which it belongs.
Collection and Transmission of Data and Biospecimens: All data, as well as any biospecimens collected,
for an NCTN trial must be sent by the institutions/sites participating in the trial to the Network Group
that is leading the trial, unless an exception is approved by the NCI/DCTD to accommodate the needs of
a specific trial. The Network Group Operations Center is responsible for overseeing the timely
collection and transmission of data and biospecimens from all its member institution/sites to NCTN
trials for patient accruals that are credited to the Network Group. Collection and banking of tissues and
other biological specimens is an increasingly important aspect of Network Group clinical research. For
NCTN trials that it leads, the Network Operations Center is responsible for coordinating the acquisition
and shipping of protocol-specified tumor specimens and biological fluids (with relevant clinical data) to
the appropriate laboratories for testing and to a tumor/specimen repository for storage of specimens
for future correlative science laboratory studies. The Network Group Operations Center is also
responsible for ensuring that all its members submit required biospecimens for NCTN trials when the
Network Group Operations Center is credited with the accrual even if the Network Group is not leading
the trial.
Trial Access and Crediting of Patient Enrollment: Network Groups member institutions/sites must be
able to enroll patients on all adult phase 3 trials (and selected phase 2 trials) conducted by the
Network, irrespective of the specific Network Group which is leading the trial and providing data
management and statistical analysis for it. Member institutions/sites of the adult Network Groups are
allowed to credit any Network Group to which they belong for patient accrual except that non-
Canadian international sites must credit the Network Group that is leading the NCTN if they are a
member of that Group to ensure consistency of regulatory oversight outside North America. Canadian
sites that belong to more than 1 Network Group may also have to credit the Network Group that holds
a Clinical Trial Application (CTA) for the trial in Canada if a CTA is required per Health Canada
regulations. Note: International sites (i.e., non-U.S. sites) that are full members of any of the Network
Group Operations Center or the Canadian Collaborating Clinical Trials Network may not be able to
participate in all NCTN trials because of special regulatory issues specific to the country of the
international member. The Network Group Operations Centers must specify any potential restrictions
related to enrollment from international members prior to trial activation.
It is also anticipated that affiliates of main members for a particular Network Group will follow the
crediting decision of the main member for a particular trial; however, that is at the discretion of the
Network Groups through their membership rules. Institutions/sites that are members of the pediatric
Network Group must credit the pediatric Network Group when it is leading a trial.
Use of the NCI Central Institutional Review Board: All U.S. institutions/sites participating in NCTN trials
as members of 1 or more Network Groups (including Network Lead Academic Participating Sites,
CCOPs, and MB-CCOPs) are required to use the pediatric and/or adult NCI Central Institutional Review
Board for any NCTN trial under an NCI CIRB’s purview. This requirement may be waived by the Lead
NCTN Program Director through an exemption review process if the institution/site can adequately
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