NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
the organizational structure, composition, and specific responsibilities of each Network Group
committee (scientific and administrative) as well as study teams and membership for
institutions/sites.
Scientific Research Committees: The primary responsibilities of the scientific research
committees are to develop the specific trial proposals (Letters of Intent (LOI) and Concepts) for
approval by the NCTN Program, oversee protocol development and trial conduct for approved
studies, and to help effect the Network Group’s overall research strategy. Disease committees
(e.g., breast, gastrointestinal, thoracic) are responsible for adhering to procedures for
study/protocol development, including adhering to time-lines for Concept and LOI development
and subsequent protocol development for approved Concepts and LOIs as set out by the
Network Group Operations Center for compliance with NCI/DTCD Operational Efficiency
Working Group timelines. Other committees (e.g. correlative science, experimental
therapeutics, experimental imaging sciences) are responsible for providing input to or
developing ancillary studies for disease committee trials that enhance the quality of the Network
Group’s overall research strategy.
Study Monitoring by Scientific Committees & Study Teams: The primary responsibility for study
monitoring resides with the Study Chair, Study Statistician and other members of the study team
that helps develop and oversees conduct of a specific study. The scientific research committee
(e.g., disease committee) is responsible for assuring that the study team is satisfactorily meeting
its responsibilities for study monitoring.
Administrative Committees: Administrative committees provide essential core service functions
to support the Network Group’s research program. For example, a patient advocacy committee
may provide guidance to a disease committee by obtaining appropriate review and input from
patient advocates with respect to clinical trials supported by the Disease Committee.
Administrative Committees should have clearly described responsibilities and mechanisms for
measuring the performance of the Committees in meeting those responsibilities. Administrative
Committees need not have explicit scientific research agendas, although the activities of these
Committees should be important or even essential to accomplishing the Network Group’s
research agenda (e.g., Audit Committee).
1.1.3 Young Investigator Mentoring/Training:
The Network Group Operations Center is responsible for having a mentorship program to involve
young investigators in Network Group clinical trial research and to help train them eventually to
take on leadership responsibilities for clinical trials and/or committees.
1.1.4 Communications Support
The Network Group Operations Center is responsible organizing and disseminating information
about the Network Group’s scientific activities and major changes in administrative policies and
procedures to its members through annual or biannual Network Group meetings that review the
Group’s progress, establish priorities, and plan future activities. Additional meetings among
Network Group members and meetings with NCI staff may be held as needed. Relevant
Network Group Operations Center responsibilities for meetings include: (a) arranging for
appropriate meeting space and accommodations for attendees; (b) developing and distributing
meeting agendas; and (c) preparing summaries as appropriate after each meeting for Network
Group members and NCI staff.
The Network Group Operations Center is responsible for establishing routine electronic
communication between itself, the associated Network Group Statistics and Data Management
Center, Cancer Trials Support Unit (CTSU), and member sites participating in its trials to facilitate
protocol development, trial conduct, and study monitoring. Relevant communication methods
include website postings, e-mail, teleconferences, and video-conferences.
Page 37 of 241