NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
All Network Group studies funded under this Cooperative Agreement, in whole or in part,
must use also use CTEP CAEPRs for agents used in NCTN trials even if the agent is used in a
trial that is not under a CTEP IND or CIP IND.
In addition, for any study using agents under a CTEP or other DCTD-sponsored IND, any
increase in the incidence of expected toxicities and any plans to change a trial design or
close a trial early due to toxicity should immediately be discussed with the Investigational
Drug Branch (IDB) and Clinical Investigations Branch (CIB) at CTEP, or the Clinical Trials
Branch at CIP if a CIP IND imaging agent is involved before any action is taken. For NCTN
studies that are not being conducted under a DCTD IND, any major patient safety issues
(e.g., study closure/suspension for adverse events, inappropriate randomization of patients
to treatment arms, etc.) also require immediate notification to the Clinical Investigations
Branch at CTEP (or Clinical Trials Branch at CIP if an IND imaging agent is involved) before
any action is taken.
In general, for studies with these types of immediate safety issues that are under monitoring
by a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) as
defined in Part 1: Section IV.B.1.5.6, immediate notification should be made to the
DSMB/DMC Chair and the Lead NCTN Program Director. For therapeutic studies that are
not under DSMB/DMC monitoring, immediate notification should be made to the disease
liaison physician in the Clinical Investigations Branch at CTEP (along with the agent liaison
physician in the Investigational Drug Branch at CTEP for studies being conducted under CTEP
IND) with a copy to the Lead NCTN Program Director. For imaging studies that are not
under DSMB/DMC monitoring and/or those being conducted in under CIP IND, immediate
notification should be made to the physician imaging agent liaison in the Clinical Trials
Branch at CIP with a copy to the Lead NCTN Program Director.
� CTRP/clinicaltrials.gov Registration and Outcomes Reporting: All NCTN trials must also be
registered and appropriate information updated in the NCI Clinical Trials Reporting Program
(CTRP) as described at: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/main as
well as registered in the U.S. National Library of Medicine clinical trials database (i.e., at
www.clinicaltrials.gov). Changes in the trial design and accrual as well as results reporting
from NCTN trials are also required to be reported in clinicaltrials.gov as required under the
Food and Drug Administration Amendments Act (FDAAA), Section 801. The Network Group
Operations Center should work with its associated Network Group Statistics and Data
Management Center to coordinate activities to ensure information on Group NCTN trials is
appropriately updated in these systems.
� CDUS/CDS Reporting: In addition, data must be submitted on all NCTN trials, as
appropriate, to the NCI/DCTD Clinical Data Update System (CDUS/CDS) at
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/cdus.htm.
The Network Group Operations Center should work with its associated Network Group
Statistics and Data Management Center to coordinate activities to ensure information on
Network Group NCTN trials is appropriately updated in all these systems.
� DSMB/DMC Recommendations for NCTN Trials: The Network Group Operations Center in
conjunction with the associated Network Group Statistics and Data Management Center
(SDMC) is required to send a listing (or an email with internet access link to a listing) of all
Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC)
recommendations accepted by the Network Group Chair(s) to the Lead NCTN Program
Director after every scheduled DSMB/DMC meeting. DSMB/DMC recommendations
accepted by the Network Group Chair(s) after ad hoc DSMB/DMC meetings/calls must also
be communicated to the Lead NCTN Program Director.
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