NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.1 – Review Criteria
Network Group Operations Center
coordination and productivity of operational activities including protocol development?
Does the staffing plan for the proposed Network Group Operations Center provide
appropriate and clearly defined position descriptions and qualifications and is it
adequate for required activities? Does the applicant propose sound financial
management policies and procedures for grant administration, subcontracting with
collaborating organizations, purchase service agreements for member institutions/sites,
and other related activities (e.g., laboratory testing needed for specific clinical trials)?
Governance: Does the applicant team define a clear governance structure for the
proposed Network Group Operations Center? If the application includes multiple
PD(s)/PI(s), is it clear how activities and responsibilities will be carried out among the
multiple PD(s)/PI(s) and is the delineation of responsibilities appropriate? Are the scope
and authority of the senior leadership, Director of Operations position, and
Executive/Advisory Committee for the proposed Network Group Operations Center
clearly and appropriately addressed? How comprehensive are the expertise and
experience of the applicant's senior administrative management team? Are the
background and expertise of the proposed Director of Operations appropriate to
oversee the operational management of the Group? Are the policies and procedures for
institution/site membership clear and appropriate for the NCTN Program? Are the
proposed operating procedures for interactions with member institutions/sites
appropriate?
If the applicant proposes to include international institutions/sites as full members of
the Network Group Operations Center, does the applicant have appropriate monitoring
plans for these sites as well as performance assessment monitoring to ensure that the
NCTN-supported activities meet the same requirements regarding conduct of clinical
trials expected of a full U.S. member institution/site? If the applicant plans to enroll
patients on trials that are led by non-NCTN international clinical trials organizations,
does the applicant propose appropriate policies and procedures to comply with
applicable regulations and requirements defined in the Terms and Conditions of the
Award for a Network Group Operations Center?
Clinical Trial Operations - Development: Are the structure and composition of trial
proposal and protocol development teams proposed by the applicant appropriate? How
well does the applicant's proposed trial proposal and protocol development process
mesh with NCI standard tools and services, including use of Common Data Elements and
standard Case Report Form modules? How appropriate are the proposed Network
Group Operations Center's policies and standardized procedures for development and
monitoring of trial proposals and protocols (including its tracking and project
management systems) for ensuring that the applicant would meet NCI-mandated trial
activation timelines for operational efficiency (i.e., Operational Efficiency Working
Group [OEWG] timelines)?
Clinical Trial Operations – Conduct: How appropriate are the proposed Network Group
Operations Center's policies for timely and efficient development and processing of
protocol amendments, including timely communication of new safety information and
amendments to member institutions/sites? Are appropriate communications policies
proposed to support the work of the scientific research and administrative committees,
coordinate activities with the associated proposed Network Group Statistics and Data
Management Centers as well as member institutions/sites and the NCI Cancer Trials
Support Unit (CTSU) related to trial conduct? Does the applicant propose appropriate
training programs for protocol chairs, institutional site PD(s)/PI(s), and CRAs? Does the
proposed Network Group Operations Center have appropriate key standard operating
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