NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget & Research Plan
Network Group SDMCs
2.1 Sub-section A. Statistics and Data Management Center Overview (up to 12 pages)
This sub-section should provide a general overview of the Statistics and Data Management
Center (SDMC) and describe the general features and operations of the SDMC. The
applicant should provide a diagram illustrating the organizational structure of the SDMC in
this sub-section, particularly the relationship between the Statistical Analysis Program and
the Data Management Program and describe how the SDMC would interact with the other
key components of the NCTN Program.
The applicant's key standard operating procedures for the conduct of clinical trials related to
the following should be provided in the Resource section of the application:
� Procedures for Statistical Analysis (e.g., guidelines for interim monitoring, general
procedures for sample size estimation, accrual rate estimation, and choice of
testing and estimation procedures)
� Data Management and Monitoring Policies & Procedures for Clinical Trials
� Procedures to Ensure Security and Confidentiality of Patient Data
� Conflict of Interest Policy
� Onsite Auditing Policy and Procedures
� Model Statistical Analysis Template for Clinical Trials
� Sample of Trial Reports (i.e., 3 trials) from the SDMC Report of Studies
2.2 Sub-section B. Statistical Analysis Program & Collaborative Research and Collective
Management (up to 30 pages)
Statistical Analysis Program: This functional component should consist of a well-defined
organization, approaches, policies, and procedures for statistical analysis of clinical trials in
specific disease areas and patient populations. The applicant should describe the
organizational structure, governance, and standard operating procedures in order to
demonstrate the applicant's capability to design, monitor, and analyze clinical trials in a
timely manner. The expertise and experience as well as the scope and authority of the
applicant's statistical leadership team, including how the team directs the Data Management
Program and how the team interacts with the Director of Operations position for the
associated Network Group Operations Center should be described, including succession
planning for key leadership positions in the statistical program.
For applications designating multiple PD(s)/PIs(s), a leadership plan related to the multiple
PD/PI designation must be included in the appropriate section of the application (i.e.,
Multiple Program Director(s)/Principal Investigator(s) (PD(s)/PIs(s), Leadership Plan section
of the PHS 398). A rationale for choosing a multiple PD/PI approach should be described. The
governance and organizational structure of the leadership team for the SDMC should be
described including communication plans, process for making decisions and procedures for
resolving conflicts. The roles and administrative, technical, and statistical responsibilities for
the SDMC should be delineated for the PD(s)/PIs(s), including responsibilities for protection
of information on human subjects in clinical studies. If budget allocation is planned, the
distribution of resources to specific components of the SDMC and/or the individual
PD(s)/PIs(s) should be delineated in the Leadership Plan. In the event of an award, the
requested allocations may be reflected in a footnote of the Notice of Award.
The applicant should describe 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
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