NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
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. 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.
Exemption requests with supporting documentation of the timely IRB review from member
institution/sites of the Network Group must be submitted to the Lead NCTN Program Director by the
supporting Network Group. If an exemption is granted, the Network Group Operations Center is
responsible for including reports of IRB timelines for their sites that have received an approved
exemption 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 institution/site use the NCI CIRB
for applicable NCTN studies if justification for the exemption is not warranted on a continuing basis.
1.3 Operational Management
1.3.1 Governance, Organizational Structure, Policies & Procedures, and Membership
The Group’s Operations Center is responsible for coordinating study proposals, protocol
development, protocol submission, study conduct, performance reporting, quality assurance
including quality control and study monitoring, protocol amendments/status changes,
adherence to requirements regarding investigational agent management and all federal
regulations. In addition, the Operations Center is responsible for the financial management of
the Network Group Operations Center, including issuing subcontracts or purchased services
agreements related to per case funding as well as overall management of the funds associated
with the Cooperative Agreement. The Network Group Operations Center is also responsible for
specifying the mix of funding available for the trial that it leads prior to trial activation as well as
for providing information in a timely manner on appropriate modifications in funding on the trial
during the course of accrual. The Network Group is also responsible for providing this
information if it is the primary lead in the U.S. for an international trial (excepting trials led by
the Canadian Collaborating Clinical Trials Network). Specific responsibilities of the Operations
Center include the following:
Governance: The Network Group Operations Center is under the leadership of a “designated”
Network Group Chair elected by the Network Group membership, who coordinate(s) all the
scientific and administrative decisions related to Network Group-funded activities and the
Network Group’s institutional members with the assistance of the staff of the associated
Network Group’s Statistics and Data Management Center. The Multiple Principal Investigator
(PI) option is encouraged for the Network Group Operations Center award given the team
science approach of the research effort. Information on the Multiple PI Option is available at
http://grants.nih.gov/grants/multi_pi/index.htm. If this option is used, the Network Group
Operations Center should designate a “Contact PI” among the multiple PIs. The designated
Network Group Chair (or Contact Principal Investigator under the Multiple PI option) is also
responsible for all grant-related activities and for communication about these activities with the
appropriate NCI/DCTD staff.
Organizational Structure, By-laws, and Standard Operating Procedures: The Network Group
Operations Center is responsible for development and maintenance of an organizational
structure for the Network Group, including a Constitution and By-laws for the Group. The
organizational structure of the Network Group Operations Center should be established with
clear and appropriate staff roles and reporting responsibilities, especially with respect to the role
and reporting responsibilities of the Network Group Director of Operations (who must also be
listed as key personnel in the Network Group Operations Center application and award). The
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