NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – NCI/DCTD Responsibilities
CTMB notification. It is also essential that involved individual(s) and/or institutions follow their own
institutional misconduct procedures in these matters.
5. Data Management and Analysis Review & Use of Standard NCTN Tools and Services
At the request of CTEP, the Biometric Research Branch (BRB) staff, in consultation with other NCI/DCTD
staff, will review mechanisms established by the Network Group for data management and analysis. When
deemed appropriate, BRB staff will make recommendations to ensure that data collection and management
procedures are adequate for quality control and analysis, yet sufficiently simple to encourage maximum
participation of physicians entering patients onto studies and to avoid unnecessary expense. In addition,
the NCI will have access to all Network Group data although the data remain the property of the awardee
institution under the Cooperative Agreement. Data must also be available for external monitoring as
required by NCI's agreement with the FDA relative to the NCI's responsibility as agent sponsor.
During the approval process for study protocols and amendments, NCI/DCTD ensures that these standard
NCTN tools and services are used. In addition, Network Group trial protocols will be periodically audited by
NCI/DCTD to ensure that the tools related to common data elements in compliance with the NCTN Program
approved sections of the data dictionary for common data elements in caDSR are used in the data collection
instruments for the NCTN trials. If issues with compliance are identified, the NCI/DCTD will work with the
Network Group to develop a corrective action plan.
6. Investigational Agent Development and Regulations
The clinical development of new anticancer agents is a highly important use of Network Group resources.
The Network Groups are a vital component of the research apparatus necessary for the clinical
development of the many new investigational agents sponsored by NCI/DCTD. Various branches within
DCTD share the responsibilities for investigational agent development, as described below.
� The Investigational Drug Branch (IDB) is responsible for: (1) planning, within CTEP as well as with
members of the extramural community, overall strategies for studies of new agents in specific
tumor types and (2) coordinating and monitoring trials of new agents developed by the DCTD.
� The Clinical Trials Branch in the Clinical Imaging Program (CIP) is responsible for: (1) planning,
within CIP as well as with members of the extramural community, overall strategies for studies of
new imaging agents in specific tumor types and (2) coordinating and monitoring trials of
new/novel imaging agents under evaluation by NCTN Network Groups.
� The Pharmaceutical Management Branch (PMB) provides for the distribution of investigational
new agents for which DCTD is the sponsor.
� The Regulatory Affairs Branch (RAB) maintains close contact and ongoing dialogue with the
pharmaceutical collaborator and with the FDA to ensure that new agent development complies
with federal regulations and proceeds in a coordinated way.
� The Clinical Investigations Branch (CIB) is involved in promoting comparative Network Group
clinical trials evaluating treatment strategies using new agents versus appropriate control
therapies.
� The Biometric Research Branch (BRB) assesses proposed designs for evaluating the benefits of
investigational agents.
� The Clinical Trials Monitoring Branch (CTMB) verifies adherence by the Network Groups to the
quality assurance procedures of investigational agent trials.
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