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. Specific Awardee Rights & Responsibilities - Network Group Statistics and Data Management Centers
Throughout these Terms and Conditions of Award, “Network Group Statistics and Data Management
Center” or “SDMC” refers to the organizational structure which is composed of the key personnel (including
the scientific and administrative leaders of the Center) responsible for implementing statistical design and
analysis as well as data management for clinical trials and collaborating on research goals of the NCTN
Program through the Center.
2.1 Statistical Analysis Program & Collaborative Research and Collective Management
2.1.1 Statistical Leadership
The Network Group’s Statistics and Data Management Center (SDMC) is responsible for the
statistical leadership of the Network Group research agenda and all aspects of data
management. The SDMC is responsible for helping the Network Group Operations Center
develop the statistical research design and analysis plan for Network Group studies as well as for
providing statistical analysis, appropriate interim monitoring plans, interpretations, and
conclusions in regard to study data.
The SDMC conducts final study analyses at the protocol-prescribed time and participates on
publication writing teams for the primary study analysis as well as secondary study analyses.
Cross-protocol analyses may be performed by the SDMC, as necessary, to support the research
agenda of the Network Group, Network Group collaborations as well as when requested by
NCI/DCTD for the NCTN Program.
2.1.2 Governance, Organizational Structure, and Policies and Procedures
Governance: The Network Group’s Statistics and Data Management Center (SDMC) is under the
leadership of the “designated” Network Group Statistician, who coordinates the statistical and
data management policies and procedures related to Network Group-funded activities with the
assistance of the staffs of the associated Network Group’s Operations Center. The Multiple
Principal Investigator (PI) option is encouraged for the Network Group SDMC award given the
team science approach of the research effort. Information on the Multiple PI Option is available
at http://grants.nih.gov/grants/multi_pi/index.htm. If this option is used, the Network Group
SDMC should designate a “Contact PI” among the multiple PIs. The Network Group Statistician
(or Contact Principal Investigator under the Multiple PI option) or designee is also responsible
for all grant-related activities and for communication about these activities with the appropriate
NCI/DCTD staff.
Organizational Structure: The SDMC is responsible for development and maintenance of an
organizational structure for the SDMC with clear and appropriate staff roles and reporting
responsibilities, especially with respect to the role and reporting responsibilities of the Network
Group Director of Operations (who must also be listed as key personnel in the Network Group
SDMC application and award). . The SDMC must also agree to abide by the Constitution and By-
Laws of its associated Network Group Operations Center.
Standard Operating Procedures: The SDMC must have Standard Operating Procedures (SOPs)
covering all aspects of data management, study monitoring, and data analysis for Network
Group trials. The SOPs should include plans for training Network Group investigators and Clinical
Research Associates (CRAs) at member participating sites and Study Chairs and Study Teams
about their responsibilities for data management and study monitoring.
2.1.3 Facilities and Equipment
The SDMC must have the appropriate facilities and equipment, especially with respect to
information technology, to provide for complete data management for all aspects of the
Network Group’s clinical trials.
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