NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Canadian Collaborating Clinical Trials Network
application merit evaluation. In this sub-section, the applicants are expected to highlight
their most relevant achievements over the past 5 to 6 years, in addition to details presented
in summary tables. Use of template Tables #8, #9, #10, and #11 as described in Part 4 -
Appendices – Section II.A. of these Guidelines for the NCTN Program is highly
recommended and may be included in the Resources section of the application.
2.4 Sub-section D. Statistics Analysis Program and Data Management (up to 12 pages)
This sub-section should consist of a well-defined organization, approaches, policies, and
procedures for statistical analysis and data management of clinical trials led by the applicant
(including any approved, multi-center Phase 2 and Phase 3 trials that originated from
investigators outside the applicant's organization).
The applicant should provide a brief description of the general approach to statistical trial
design and analysis plans for multi-institutional clinical trials, including guidelines for interim
monitoring and general procedures for sample size estimation and choice of testing and
estimation procedures. Examples of robust statistical trial designs and statistical support
should be described as well as how the organization provides statistical leadership in design
and analysis, including incorporating new, integral and integrated, molecular and imaging
biomarkers and laboratory studies into the overall evaluation of NCTN trials. The applicant
should also describe how the organization ensures that final study analyses are performed in
a manner to provide timely publication of study results and results reporting per NCI and
federal regulations.
The applicant should provide a brief description of the data management and study
monitoring practices of the SDMC, including the flow and review of data following
submission from individual institutions/sites and investigators. The applicant should
describe the data management systems employed and how the SDMC would use standard
NCTN tools including the NCTN Common Data Management System (CDMS) and use of
NCTN-approved 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.
Brief descriptions of training for investigators (including mentorship for junior investigators),
Clinical Research Associates, and study chairs related to data management and study
monitoring for clinical trials should be provided. The applicant should also describe
procedures for study monitoring as well as for data quality control and accuracy verification,
including how the organization conducts auditing activities. The applicant's method for
active trial monitoring, including procedures for accrual and biospecimen collection tracking,
assessing case, eligibility and evaluability, ensuring timely medical review and assessment of
patient data, monitoring of data timeliness, and facilitating staff interactions with study
chairs should be described briefly. The applicant should describe the organization's
guidelines for institutions/sites for data timelines, including a summary of data quality and
timeliness as an indication of its potential to operate efficiently within the NCTN Program.
This information may be summarized in a table. Information on the Statistics Analysis and
Data Management Program may be summarized in a series of tables. Use of template Tables
#1, #2, and #3 as described in Part 4 – Appendices – Section II.B. of these Guidelines is highly
recommended and may be included in the Resources section of the application.
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