NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 3: Submission Non-Competing Applications Section II – Research Plan & Budget II. Non-Competing Continuation Applications Format and Budget Requests The information included in a non-competing continuation application (also called an annual progress reports or Type 5 Application) should be provided in formats similar to the ones presented in this Part of the Guidelines and should follow the requirements of the PHS2590 available at: http://grants.nih.gov/grants/funding/2590/2590.htm. Providing the information in a standard format will allow both the key component of the NCTN Program and the responsible the responsible Lead NCTN Program Director and Co-Program Directors/Project Scientists to evaluate the progress of the key component more easily and to identify areas that need attention. The format may be varied somewhat, depending on the key component submitting the application; however, it should be similar to what is presented here. The instructions on the following pages cover application formats for all key components of the NCTN Program. The non-competing continuation application must specify the 12-month period for which data are being reported, and this same 12-month period should be used for all information presented. It is anticipated that additional instructions/modification as to what information should be included in the annual progress report may be given to awardees of all the key components of the NCTN Program by the Lead NCTN Program Director prior to submission of the first annual progress report, especially with respect to streamlining the report. A. Applications for all Key Components of the NCTN Program 1. Research Plan (Annual Progress Report – Type 5 Application) The Research Plan for each Type 5 application should follow the requirements of the PHS2590. In all cases, brief and concise descriptions in the research plan of annual progress are encouraged. Sections 1.1 and 1.2 on accrual and clinical trial performance described below apply only to the annual progress reports for the Network Group Operations Centers, the Canadian Collaborating Clinical Trials Network, and the Network Lead Academic Participating Sites. Section 1.3 on clinical trial development applies only to the annual progress reports for the Network Group Operations Centers and the Canadian Collaborating Clinical Trials Network. 1.1 Accrual Performance & Accrual by Gender and Ethnicity/Race Network Group Operations Centers, Network Academic Participating Sites, and the Canadian Collaborating Clinical Trials Network should provide a summary table that lists the number of patients accrued during the current funding period (i.e., the three [3] most recently completed quarters during the funding period plus a projection for the current fourth quarter) with the exact calendar dates/time-periods used to provide the actual and projected accrual noted at the top of the table. Accrual for all studies (treatment and advanced imaging) and per patient biospecimen collection on trials that were open during the annual project period should be reported summarized by major disease category and trial phase. A similar report summing accrual across all disease areas should also be provided. Total accrual provided by the Network Group Operation Center’s or the Canadian Collaborating Clinical Trials Network for all its member institutions/sites (or by the Network Lead Academic Participating Site for its sites and affiliate(s) for which it provides complete management serviced) broken down by sex/gender and ethnicity/race for all accrual across all NCTN trials should also be presented using the standard Inclusion Enrollment Report format provided in the PHS2590. This table should be modified to show sex/gender and ethnicity/race breakdown in accrual for the previous 3 years (if applicable) in addition to the current funding period summarized by major disease category only. A summary table for accrual across all diseases should also be provided. Distribution of subjects should NOT be provided by individual study or trial phase. Page 188 of 241
TYPE OF STUDY PART 3: Submission Non-Competing Applications Section II – Research Plan & Budget Summary Accrual Table for ALL Studies by a Network Group Operations Center or Canadian Collaborating Clinical Trials Network 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 Led by Network Group: Actual (projected) Accrual - Credited to Group Actual (projected) Accrual - Credited to Other Groups ========================================== Patients Enrolled in Current Period on All NCTN Studies NOT Led by Network Group: Actual (projected) Accrual - Credited to Group Total Patients in Follow-Up on All NCTN Studies Led by Network Group Actual (projected) – Credited to Any Group 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 189 of 241 ALL Treatment or Advanced Imaging Studies
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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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