NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 3: Submission Non-Competing Applications Section II – Research Plan & Budget
1.2 Clinical Trial Performance
Network Group Operations Centers (or Network Lead Academic Participating Sites) should
also summarize the timeliness of AdEERS reports submission, the date of the last audit for
institutional members (or Lead Academic Participating Site), compliance with specimen
submission, etc. in the annual report.
The NCI-Guidelines for Onsite Monitoring of Clinical Trials for Cooperative Groups, CCOP
Research Bases, and the Cancer Trials Support Unit (CTSU) require all institutions to be
audited at least once every 36 months. In order for NCI to review the Network Group
Operations Center’s compliance with this requirement, each Network Group Operations
Center should conduct an annual review of all audits performed and provide in the noncompeting
continuation application an accounting similar to the table provided for new
applications. Any significant audit problems, as defined in the Clinical Trials Monitoring
Branch Guidelines for Onsite Auditing, encountered during the preceding year should be
fully described and the corrective action(s) taken explained for any Network Group
Operations Center’s institutional/site members (including and Network Lead Academic
Participating Site).
The Network Lead Academic Participating Sites should also provide a similar report for any
audits conducted during the reporting period for the main academic site and any individual
components that are audited as well as any affiliate(s) for which the main academic site
provides complete management services.
1.3 Timelines for Protocol Development, Trial Activation, and Trial Completion
The annual progress report should list protocol development activities during the current
funding period for the Network Group Operations Centers and the Canadian Collaborating
Clinical Trials Network, in terms of submitted and approved Letters of Intent (LOIs) and
Concepts, submitted and approved protocols, activated and completed trials with associated
OEWG timelines. This table should be organized by major disease category and then by trial
phase.
1.4 Progress & Summary of Research Accomplishments of Key Components of NCTN Program
The annual progress report for each key component of the NCTN Program should report on
the component’s progress regarding the goals and activities outlined in the research plan of
the corresponding Type 1 application (or Type 2 application, if applicable in the future). This
should include information on how the key component has contributed to the goals of the
NCTN Program with emphasis on what the key component has accomplished in the current
funding period.
The application should provide a brief, narrative description of the contributions of the key
component to NCTN clinical trials and research goals and other NCTN Program activities and
initiatives, including important collaborations, during the current funding period. This
summary narrative should be adequate to convey the important facets of the activity and
any significant findings (e.g., patients accrued, open dose level, important toxicities
observed, pharmacokinetic findings, anti-tumor activity observed, scientific leadership on
new trials, translational science advances, etc.).
The annual progress report should list the titles and complete references of all publications
not previously reported. This includes manuscripts submitted or accepted for publication.
Only those publications resulting directly from activities of the key component of the NCTN
Program funded by the Cooperative Agreement should be reported.
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