NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group
Statistics and Data Management Centers (SDMCs)
2.1.4 Collaborative Research and Collective Management
The SDMC is responsible for supporting the statistical analyses for collaborations with other
Network Groups as well as other NCI-sponsored programs and investigators (e.g., SPOREs,
Cancer Centers, R01/P01 investigators) to augment and enhance the clinical research strategy
and research productivity of its portfolio of clinical trials conducted in the NCTN. The SDMC
should also be able to provide statistical and data management support for trials that originate
from outside the Network Group that are prioritized by the NCI Scientific Steering Committees
and approved by NCI as well as for other collaborations with NCI-sponsored early phase clinical
trials networks under the NCTN Program.
Independent research by the SDMC should be focused on developing innovative clinical trial
designs and analysis methodologies consistent with the Network Group research agenda and
appropriate for planned studies. While NCI/DCTD encourages development of and
experimentation with new study designs within the Network Group framework, purely statistical
research unrelated to Network Group studies must be funded through other mechanisms.
In addition, the SDMC is also responsible for participating in the collective management of the
Network including participation in appropriate NCTN Program activities and initiatives (e.g., NCI
Scientific Steering Committees, NCI CIRB, etc.) and through the NCTN Leadership Management
Committee by making recommendations to NCI for modifications to the Program as well as to
standard NCTN common tools and services.
2.2 Data Management
2.2.1 Data Management Policies and Use of Standard NCI Tools
The SDMC should establish data management policies and procedures for ensuring data
accuracy, timeliness, completeness, and consistency for Network Group NCTN trials. The
general categories that should be addressed by the SDMC data management policies are listed
below.
� The SDMC should provide a data management system for central storage, security,
processing and retrieval of study results that incorporates security features consistent with
DHHS guidelines.
� The SDMC should have procedures for backing up the Network Group’s clinical and
administrative data, including intermittent duplication of the database with storage at a
remote facility.
� The SDMC should protecting patient confidentiality at all steps in the submission and
analysis of clinical trials data and ensure the technical integrity and security of patient in
compliance with federal regulations, including the Health Insurance Portability and
Accountability Act (HIPPA).
� The SDMC must ensure, in coordination with the Network Group Operations Center, that
data management operating policies and practices are in compliance with the Network
Group’s official policy on sharing research data (e.g., Data Sharing Policy) as approved by
NCI/DCTD.
� The SDMC is required to use standard NCTN tools and services for the design and conduct of
NCTN trials including, but not limited to: (a) the Common Data Management System for
study design/build and data collection with case report reports (CRFs) designed by the
SDMC that are compliant with the NCTN Program approved sections of the data dictionary
for common data elements in the NCI Cancer Data Standards Registry and Repository
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