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
section and describe how the Canadian Collaborating Clinical Trials Network 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:
� Data and Safety Monitoring Board Policy for Phase 3 Trials & Randomized Phase 2 Trials
� Data and Safety Monitoring Plan for Phase 1 and Phase 2 Trials
� Conflict of Interest Policy
� Onsite Auditing Policy and Procedures
� Constitution & By-laws for Institution/Site Membership and Individual
Participant/Investigator Membership (including Scientific and Administrative Committee
Membership)
� Standard Template for the Informed Consent Document
� 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
� 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. Clinical Trial Development & Member Site Accrual Program (up to 12
pages)
This sub-section should consist of a well-defined research strategy by the applicant for the
development of clinical trials with a specific research focus and patient populations that
complement the research strategy of the U.S. NCTN Program. In particular, the applicant
should address how its research agenda will complement the NCTN Program as a whole even
though the applicant would be expected to participate in only a limited portion of the NCTN
Program. The applicant should address how it decides what research collaborations to
pursue with the NCTN Program. The applicant should highlight its most important
achievements over the past 5 to 6 years as well as its most promising current and future
research initiatives and trials as an indication of its potential to contribute to the NCTN
Program. This sub-section should also include information on the applicant’s senior research
teams (for scientific research committees and administrative committees) and the applicant
should also describe how it will mentor new/young investigators in clinical trial research.
NOTE: Information on the applicant’s scientific leadership in clinical trial development as
well as achievements of its past (over the prior 5 to 6 years) and current clinical trial
development program may be summarized in tables. Use of template Tables #1, #2, #3, and
#4 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.
This sub-section should also consist of a well-defined plan for accrual to NCTN trials by the
applicant's member institutions/sites. This plan should encompass accrual to the occasional
trial led by the applicant as well as trials that will be led by U.S. Network Groups Operations
Centers. Emphasis should be placed on overall accrual across the entire NCTN. This subsection
should present information on the potential of the applicant to accrue patients to
oncology clinical treatment trials and advanced imaging trials in a publicly funded clinical
trials system across a broad range of diseases, including rare cancers, via its member
institutions/sites.
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