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
NOTE: The applicants are expected to highlight the track record of the applicant team and
its member site for accrual over the past 5 to 6 years, summarized in tables. Use of
template Tables #5, #6, and #7 as described in Part 4 - Appendices – Section II.A. of these
Guidelines document for the NCTN Program is highly recommended and may be included in
the Resources section of the application.
2.3 Sub-section C. Operational Management (up to 6 pages)
This sub-section should describe the applicant's organizational structure, governance,
standard operating procedures, and operational efficiency program in order to demonstrate
the applicant applicant's capability to develop, activate, and conduct clinical trials in a timely
manner.
The scope and authority of the applicant's leadership team for operations, statistics, and
data management, the Director of Operations position, and the Executive/Advisory
Committee should be described, including succession planning for key leadership positions.
This description should also include the relationship/rules for institutional membership in
the Canadian Collaborating Clinical Trials Network as well as financial management policies.
For applications designating multiple PD(s)/PI(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)/PI(s)) Leadership Plan section of
the PHS 398). A rationale for choosing a multiple PD(s)/PI(s) approach should be described.
The governance and organizational structure of the leadership team for the Canadian
Collaborating Clinical Trials Network should be described including communication plans,
process for making decisions on scientific direction, and procedures for resolving conflicts.
The roles and administrative, technical, and scientific responsibilities for the organization
should be delineated for the PD(s)/PI(s), including responsibilities for human subjects in
clinical studies. If budget allocation is planned, the distribution of resources to specific
components of the organization and/or the individual PD(s)/PI(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's plan for operational efficiency in study development, trial activation, and
timely completion of studies it leads as well as timely activation within Canada for NCTN
trials that the Canadian Collaborating Network decides to participate in. The applicant team
should describe how it will provides regulatory support for Canadian sites to participate in
NCTN trials led by U.S. Network Groups
Also, explain how the Canadian team will use the NCI standard tools and services for the
conduct of clinical trials (e.g., Clinical Data Management System, Oncology Patient
Enrollment System, and Regulatory Support System for the NCTN). Address how the
Canadian Collaborating Network will assure compliance with NCI, NIH, and HHS policies and
all applicable U.S. federal regulations regarding the protection of human subjects in clinical
research. Explain how the Canadian Collaborating Network will address study monitoring
and reporting (e.g., explain how these aspects are covered by the applicant’s policies on
Data and Safety Monitoring, Data Sharing, Biospecimen Sharing, Onsite Auditing, and Clinical
Trial Registration and Reporting. Describe the applicant’s plan to ensure that results from
clinical trials will be published in peer-reviewed manuscripts in a timely manner consistent
with NCTN Program requirements.
NOTE: The applicant’s capabilities and potential to conduct large-scale operations related to
developing, activating, and conducting clinical trials is essential and will be a factor in the
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