NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – NCI/DCTD Responsibilities
In addition, CTMB staff serves as an educational resource to the cancer research community on issues
related to monitoring and regulatory requirements for the conduct of clinical trials. CTMB staff review
audit reports and findings and assess the adequacy and acceptability of any corrective actions. To assure
consistency in the conduct of onsite audits, CTMB staff or its designee(s) may attend certain onsite audits.
The CTMB has developed the CTMB Audit Information System which permits the on-line submission by the
Network Group Operations Centers of all data related to quality assurance onsite. This includes the
submission of audit schedules, acknowledgment of receipt of preliminary reports, transmission of final
audit reports, and tracking of follow-up responses to audit findings. The system allows restricted access to
the stored data and keeps a record of any data changes. The CTMB Audit Information System can be
accessed only after providing a username and password. A major component of the CTMB Audit
Information System is a module that maintains a roster of member institutions/sites in each Network Group
Operations Center. This roster information is used for determining compliance with monitoring
requirements.
The Network Group Operations Center is responsible for ensuring that all member institutions/sites have
routine audits in accordance with the NCI-CTMB Guidelines for Monitoring of Clinical Trials for Cooperative
Groups, CCOP Research Bases, and the Cancer Trials Support Unit (CTSU) at:
http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm and that the results
of audits are reported to the NCI in accordance with the guidelines. In the event that the NCI/CTMB
determines that a Network Group Operations Center member institution/site fails to comply with these
guidelines, the CTMB may, in consultation with the Network Group Operations Center, suspend the
member institution/site immediately from participating in any NCTN trials led by the Network Group
Operations Center or all NCTN trials regardless of the Center leading the study. The suspension will remain
in effect until the Network Group Operations Center conducts the required audit and the audit report or
remedial action is accepted by the Network Group and the NCI.
The Network Group Operations Center will be responsible for notifying any affected the member
institution/site of the suspension. During the suspension period, no funds from this award may be provided
to the member institution/site for new accruals, and no charges to the award for new accruals will be
permitted. The NCI will also notify a Lead Academic Participating Site that is the direct recipient of a
Cooperative Agreement award under the NCTN Program if it is necessary to suspend accrual at the
Academic Participating Site or at an affiliate site supported under that Lead Academic Participating Site's
Cooperative Agreement based on the Network Group’s audit.
The CTMB staff will review and provide advice regarding mechanisms established by the Network Group
Operations Center and its associated Network Group SDMC for quality control of therapeutic and diagnostic
modalities employed in its trials. The CTMB staff reviews and approves the mechanisms established by the
Network Group Operations Center and its associated Network Group SDMC for study monitoring including
its onsite auditing program. CTEP and/or its contractor staff may attend, as observers, the onsite audits
conducted by the Network Group Operations Center. The frequency of participation by an NCI
representative as observer will be determined by the NCI.
Any data irregularities identified through quality control procedures or through the audit program that
raise any suspicion of intentional misrepresentation of data must be immediately reported to CTMB,
CTEP, NCI. The CTMB must be notified immediately by telephone [301-496-0510] of any findings suspicious
and/or suggestive of intentional misrepresentation of data and or disregard for regulatory safeguards for
any of the three (regulatory, pharmacy, and patient care) components of an audit. Similarly, any data
irregularities identified through other quality control procedures suspicious and/or suggestive of intentional
misrepresentation of data must be immediately reported to CTMB. It is the responsibility of the Network
Group Operations Center, CCOP Research Base, or CTSU to immediately notify CTMB when they learn of
any significant irregularities or allegations related to scientific misconduct by a staff member or institution
participating in the NCTN Program’s clinical trials. It should be emphasized that the
irregularity/misrepresentation does not need to be proven, a reasonable level of suspicion suffices for CTEP
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