NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
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.
1.4 Program for Collaborations and Participation in Collective Management
The Network Group Operations Center is responsible for developing collaborations with other Network
Groups as well as other NCI-sponsored programs and investigators (e.g., SPOREs, Cancer Centers,
R01/P01 investigators) to augment and enhance the clinical research strategy and research productivity
of its portfolio of clinical trials conducted in the NCTN. In addition, the Network Group Operations
Center is also responsible for participating in the collective management of the Network including
participation in appropriate NCTN Program activities and initiatives (e.g., NCI Scientific Steering
Committees, NCI CIRB, etc.) and through the NCTN Leadership Management Committee by making
recommendations to NCI for modifications to the Program as well as to standard NCTN common tools
and services.
Each Network Group Operations Center is required to have policies to encourage other Network
Groups to name co-principal investigators for studies that the Center leads (in disease areas that other
Network Groups have scientific research goals and/or scientific research committees) in order to
augment accrual via collaboration on its NCTN trials.
1.5 Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans
The Network Group Operations Center is responsible for assuring that the Network Group and its
member sites are in compliance with all applicable federal regulations concerning the conduct of
human subjects research. Policies and guidelines to be addressed include the following:
1.5.1 Office for Human Research Protection (OHRP) Assurances
The Network Group Operations Center must assure that each member (this includes all affiliates
or participating sites enrolling patients under any of the membership categories for the Network
Group) has a current, approved Federalwide Assurance (FWA), on file with OHRP. Information
on assurances is available on the OHRP website at: http://www.hhs.gov/ohrp/. In addition,
federal regulations (45CFR46) require that applications and proposals involving human subjects
must be evaluated with reference to risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others, and the importance
of the knowledge gained or to be gained.
1.5.2 IRB Review of NCTN Trials by Member Institutions/Sites
The Network Group Operations Center must assure that each protocol for an NCTN trial that one
of its member institutions/sites credits to the Network Group is reviewed and approved by the
appropriate Institutional Review Board (IRB) of the Network Group member prior to patient
entry via the Regulatory Support Services (RSS) of the CTSU, and assure that each protocol is
reviewed annually by the IRB so long as the protocol is active (it is anticipated that the adult or
pediatric NCI CIRB will be the IRB of record in most cases). The Network Group must ensure that
each member site of the Group forwards its regulatory documents to RSS, otherwise the site will
not be allowed to enroll patients on NCTN trials.
1.5.3 Assurance of Appropriate Informed Consent by Member Institutions/Sites
The Network Group Operations Center must have procedures in place to ensure that each
member institution/site is trained and understands the policies and procedures relevant to
ensuring that patients are enrolled on studies with appropriate informed consent per NCI/NIH
policy and federal regulations. The template for the NCI informed consent document must be
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