NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Lead Academic Sites
The Lead Academic Participating Site governance should clearly describe how activities related
to the NCTN across various disciplines and departments at the institution will be coordinated
and, in particular, describe how funding associated with patient enrollment will be distributed to
the various disciplines and clinical departments involved in NCTN trials at the institution. This is
considered critical to achieve the aims of the NCTN which supports clinical trials across a broad
range of diseases and involves multiple disciplines.
Institutional Support (Facilities, Equipment, and Programs): The Lead Academic Participating
Site’s facilities, equipment, and programs should include comprehensive medical training
programs and preclinical laboratories that perform basic research to help foster collaborations
with the clinical investigators at the site who participate in the NCTN that will enhance NCTN
research.
Affiliates: If the Lead Academic Participating Site has affiliates, the affiliate network must be
clearly described (including reference to the distinct NCI institutional codes for the affiliates that
are used for patient enrollment). The Lead Academic Participating Site must provide all data
management activities for the affiliate if it is included in the award (i.e., the Lead Academic
Participating Site is responsible for complete monitoring and management of the enrollment of
patients at affiliate sites to NCTN trials).
4.1.4 NCI Central Institutional Review Board Membership
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. See http://www.ncicirb.org for information on the requirements for a
signatory institution under the adult NCI CIRB. This requirement may be waived by the Lead
NCTN Program Director through an exemption review process if the institution/site can
adequately show that NCTN studies can be reviewed in a timely manner by its local IRB (or other
Central IRB) that is equivalent to the review timelines for the NCI CIRB (i.e., about 35 to 48 days
for initial review) or if the institution/site can demonstrate other exceptional circumstances that
preclude it from using the NCI CIRB.
Exemption requests with supporting documentation of the timely IRB review must be submitted
to the Lead NCTN Program Director by the PI(s)/PD(s) of the Network Lead Academic
Participating Site. If an exemption is granted, the Network Lead Academic Participating Site is
responsible for including reports of IRB timelines in its annual progress report as well as any
other pertinent information. The Lead NCTN Program Director may withdraw the exemption
and require that the Network Lead Academic Participating Site use the NCI CIRB for applicable
NCTN studies if justification for the exemption is not warranted on a continuing basis.
4.1.5 Clinical Trials Operations – Conduct of Clinical Trials & Data Management
The Lead Academic Participating Sites should have a clearly articulated process for prioritizing
which NCTN trials to activate at their institutions. Investigators at Lead Academic Participating
Sites form the cornerstone of the research programs for the Network Groups of the NCTN and
must perform at a high level through submission of accurate and timely clinical data as well as
ancillary materials necessary to support the NCTN (e.g., tumor specimens, imaging studies,
pathology slides). The Principal Investigator(s) at each Lead Academic Participating Site is
responsible for the performance of the academic center and its essential components as well as
of any affiliates for which it provides complete management services and for assuring adherence
to NCTN, Network Group, NCI, OHRP, and FDA policies and procedures.
It is the responsibility of the Principal Investigator(s) at the site to ensure that the procedures for
data submission for each NCTN protocol are understood by all investigators at the academic
center and its essential components as well as at any affiliates, and that protocol-specified data
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