NCI National Clinical Trials Network (NCTN) Program Guidelines

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TYPE OF STUDY PART 3: Submission Non-Competing Applications Section II – Research Plan & Budget Summary Accrual Table for ALL Studies by a Lead Academic Participating Site (LAPS) by Annual Funding Period - (Annual Grant Year) Disease Area: _______________ (AND PROVIDE REPORT SUMMARIZING ACCRUAL ACROSS ALL DISEASE AREAS) Time Period (Calendar Dates) for Actual Accrual: ___________________________________________ Time Period (Calendar Dates) for Projected Accrual: __________________________________________ Patients Enrolled in Current Period on All NCTN Studies by LAPS & Affiliates: Actual (projected) Accrual - Lead Center/Components Actual (projected) Accrual - Affiliates (Affiliates are those completely managed by LAPS and included in the LAPS award PILOT Treatment or Advanced Imaging Studies (% Screened Pts) PHASE 1 Treatment or Advanced Imaging Studies (% Screened Pts) PHASE 2 Treatment or Advanced Imaging Studies (% Screened Pts) PHASE 3 Treatment or Advanced Imaging Studies (% Screened Pts) Other Per Patient Special or Biospecimen Collection (% Biospecimen Pts) � Accrual figures should include both eligible and ineligible patients. Follow-up figures should include any patients in follow-up at any time during the current funding period being reported in the application. � Pilot studies refer to studies testing the feasibility of administration of the therapeutic intervention/approach and any other trials that do not fit into the other categories listed. � Actual data should usually be available for the 3 most recently completed quarters of the annual grant year (funding period) and data should be projected for the current quarter; however, the applicant should list the specific calendar dates for actual data and the specific calendar dates for the projected data supplied in the heading information for the table so that it is clear to reviewers what is being presented. If an applicant does not make projections by certain categories (e.g., the applicant projects data only by “all studies” not by specific categories of studies, the applicant should designate that this information is “Not Available” in the appropriate location in the table. The designation of “Not Applicable” should be used to indicate that that category is not appropriate for the applicant and no data will be forthcoming for that category. � A patient in follow-up is defined as a patient who is 1 year from his/her effective on-study date, who is not known to be dead, and for whom at least annual follow-up is required Page 190 of 241 ALL Treatment or Advanced Imaging Studies
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. Page 191 of 241
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Part 4: Summary of Updates to Guide
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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