NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria
Canadian Collaborating Clinical Trials Network
peer-reviewed manuscripts in a timely manner consistent with NCTN Program
requirements?
Compliance/Quality Assurance/Auditing: How well do the applicant's policies and
procedures proposed for the conduct of NCTN-supported clinical trials comply with
good clinical practice, including all applicable NCI, NIH, and HHS policies and U.S.
federal regulations related to clinical trial research with human subjects, as well as
with NCI/DCTD requirements related to the NCI/DCTD IP policy, NCI/DCTD CRADAs,
CTAs, and CSA for clinical trials conducted under an NCI IND, NCI IDE, or NCI binding
collaborative agreements? How appropriate are the applicant's proposed policies and
procedures in meeting the onsite audit requirements of the NCI National Clinical Trials
Monitoring Branch Guidelines (CTMB) for its member institutions/sites? How
appropriate are the applicant's plans to appropriately address issues with member
institutions/sites noted at the time of audit, including non-compliance, data quality,
data reporting requirement, and timeliness of audits and re-audits? Does the
applicant propose a quality assurance program that is adequately proactive in terms
of ensuring ongoing quality control of data during trial conduct?
2.6.5 Additional Review Item C - Statistics Analysis and Data Management Program
Statistics Analysis: How well has the proposed Canadian Collaborating Clinical Trials
Network demonstrated its ability and track record to provide appropriately designed,
robust, statistical analysis plans for early phase and especially late phase, definitive,
multi-institutional clinical trials in oncology, including integral and integrated
biomarker/correlative science studies? Does it appear that the applicant has the
necessary expertise and experience to incorporate new molecular and imaging
biomarkers into the overall evaluation of NCTN trials appropriately? Are the
procedures for sample size estimation, end point selection, and monitoring plans
adequately described and justified? Are analytical techniques, procedures, and
policies adequate, appropriate, and consistent with accepted standards? Does the
sample of trial reports from the Report of Studies indicated appropriate and timely
data and study analyses?
Data Management: Does the applicant describe well defined policies and procedures
for data management of NCTN trials? How appropriate and robust are the data
management and study monitoring practices of the organization? How well do the
data management systems employed by the proposed SDMC use standard NCTN tools
including the NCTN Common Data Management System (CDMS) and use of NCTNapproved
Common Data Element (CDEs) from the caDSR, the NCTN Regulatory
Support System (RSS), the NCTN Oncology Patient Enrollment Network (OPEN), the
NCI/DCTD Clinical Data Update Systems (CDUS/CDS), the NCI Expedited Adverse Event
Reporting System (AdEERs), the NCI Common Terminology Criteria for Adverse Events
(CTCAE) for data management for NCTN trials, and trial registration in the NCI Clinical
Trials Reporting Program (CTRP) and in the U.S. National Library of Medicine (NLM)
(www.clinicaltrials.gov) along with results reporting, as applicable?
Does the proposed Canadian Collaborating Clinical Trials Network have appropriate
procedures in place to ensure that the NCTN-supported activities are in compliance
for the conduct of clinical trials with respect to NCI/DCTD's IP Option and NCI/DCTD's
collaborative binding agreements for NCI/DCTD IND studies?
Does the Canadian Collaborating Clinical Trials Network have clear guidelines for
institutions/sites related to data timeliness and metrics for data quality for the clinical
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