NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
Operations Center is also responsible for the preparation and maintenance of Standard
Operating Procedures (SOPs) that cover all aspects of the Network Group’s activities.
The organizational structure should encompass the Scientific Research and Administrative
Committees that the Network Group will need to support its research objectives as well any
Executive Committee that the Network Group elects to establish. There should be clearly
defined term limits and succession/transition plans for the senior leadership of the Network
Group and for the leadership of its committees. Terms for the key scientific leadership positions
of a Network Group (e.g., designated Network Group Chair, disease committee Chairs, etc.)
should be limited to encourage participation by new investigators and to ensure a diversity of
views over time. The process for filling elected positions for scientific leadership positions
should be well described in the By-laws of the Network Group along with details of any
exceptions to term limits.
Institutional Membership: As described under the Member Site Accrual Program section above,
the Network Group Operations Center is responsible for establishing, maintaining, and
monitoring all its members (i.e., Lead Academic Participating Site members and affiliates, CCOPs,
MB-CCOP, pediatric sites, and other member institutions/sites) that participate in NCTN trials
and credit the Network Group with patient accrual. The Network Group Operations Center must
have a single consolidated roster of all these member categories for the Group that is
incorporated into the CTSU Regulatory Support Services (RSS) and the Oncology Patient
Enrollment Network (OPEN) systems to ensure that patients can be enrolled with appropriate
crediting and accounting. As noted above under the Member Site Accrual Program section,
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.
1.3.2 Development of Study Proposals & Protocols for Clinical Trials
The Network Group Chair shall designate other Network Group investigators to serve as Study
Chairs for each proposed study/protocol. The Network Group Operations Center is responsible
for establishing policies and procedures for development and submission of Network Group
study proposals and protocols to the NCI/DCTD/CTEP Protocol and Information Office (PIO) in a
timely fashion for review and approval by NCI. The Operations Center is also responsible for
assembling appropriate study teams for both protocol development and overseeing conduct of
approved trials. The Network Group Operations Center has these responsibilities for conduct of
approved trials regardless of whether the trial proposal originates from an investigator within or
outside the Network Group. 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 or NCI/DCTD’s Protocol
Review Committee for conduct under the NCTN Program.
Study proposals and protocols (as well as correlative science studies requesting use of
biospecimens collected during the conduct of NCTN trials) should be developed, submitted, and
implemented in accordance with instructions set forth in the DCTD Investigator Handbook (A
Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP,
DCTD, NCI) available at:
http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm, including the use of
all required standard forms. Study proposal and protocols should also be developed per the
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