NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications B. Network Group SDMCs & Canadian Collaborating Network – List of Tables with Suggested Formats - Current and/or relevant information in the past 5-6 years should be used in the tables unless otherwise indicated. Suggested reporting period over the past 5-6 years for all tables requested for the application, unless otherwise indicated, is January 1, 2007 through June 30, 2012). Network SDMC applicants should include key leadership and other information (e.g., data timeliness) from participation in the former NCI-sponsored Cooperative Group Clinical Trials Program. Only if the applicant did not participate in the former NCI-sponsored Cooperative Group Program should the applicant provide information from cancer clinical treatment trials supported by an equivalent non-profit, late-phase (primarily phase 3) clinical trials network organization that conducts oncology treatment trials. Data quality and timeline tables are for cancer treatment trials only; if applicant wishes to emphasize these parameters on past primary, advanced imaging studies under the NCI Cooperative Group Program funded by NCI Division of Cancer Treatment & Diagnosis (DCTD) or equivalent system for applicants who did not participate in NCI Cooperative Group Program, that information can be presented in the text of the Research Plan under the “Data Management” section if primary advanced imaging studies are a primary focus of the Network Group (however, the key leadership staffing table should reflect positions related to both treatment and primary, advanced imaging trials). Table 1. Key Leadership Staffing for the SDMC – Use the same format and reporting date as in the table for the Network Group Operations Center Application This table should reflect current positions in the Network Group held by investigators & their institutional affiliation as of the date this table was prepared for inclusion in application. Please Note: For key positions by Network Group Statistics and Data Management staff/investigators in NCI Scientific Steering Committees, task forces and working Groups, NCI CIRB, etc., that information should be provided in text of the “Statistical Analysis Program & Collaborative Research and Collective Management” of Research Plan for Network SDMC (see page 119 on research plan & page 163 on review criteria). For Canadian Collaborating Clinical Trial Network applicants, this information should be provided in text of the “Program for Collaborations and Participation in Collective Management” of Research Plan (see page 144 on research plan & page 182 on review criteria). Table 2. Summary of General Data Timeliness* for Open Treatment Studies MM/DD/YYYY to MM/DD/YYYY for Open Treatment Studies Led by Applicant Network Group (Include only studies open over past 5-6 years) Phase Trials Phase 1 Phase 2 (includes Phase 1/2 Studies) Phase 3 (includes Phase 2/3 Studies) Year Accrual 1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6 % Eligible Patients Eligibility CRF Reporting % Timeliness Eligibility CRF Reporting % Accuracy Treatment Cycle # (or Equivalent) % Timeliness Treatment Cycle # (or Equivalent) % Accuracy Off-Study CRF Reporting % Timeliness *Applicant team can select major CRF categories that it believes represent a measure of the submission of general data timeliness to its trials (the columns above are examples only). Also, table may report general data timeliness by members of applicant Network Group as well as by non-members of the applicant Network Group to trials led by the applicant. Page 202 of 241 Off-Study CRF Reporting % Accuracy
PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications Table 3. Summary of Data Quality and Data Timeliness – Serious AE Reporting for All Member Sites for Treatment Trials Led by the Applicant Network Group from MM/DD/YYYY to MM/DD/YYYY Summary Statistics for All Member Institutions/Sites for Applicant Network Group for Accrual to Treatment Trials LED by the Network Group Year 1 2 3 4 5 6 (or for first 6 months of year 6) Definitions: Accrual to Treatment Trials % Eligible Patients ADR/SAE Reporting % Timeliness ADR/SAE Reporting % Accuracy � Accrual data is for Group studies (i.e., Group-only and Group-Led Intergroup studies). � ADR = AdEERS; SAE = Serious Adverse Event. % Follow-up Forms Submitted on Time � Accuracy percentage for ADR/SAE Reporting is the percent of ADR forms amended for a change in toxicity Grade or addition of a toxicity Grade 3+. For example, if the total number of ADR forms received during the time-period covered by the report is 1,000, and out of those 1,000 ADR reports, 45 of them required a change in toxicity Grade or the addition of a grade 3+ or higher AE, then the accuracy percentage would be calculated as: ((1000 – 45) / 1000) = 95.5%. Groups should provide the exact definition that they use to calculate their accuracy percentage with this report in a brief paragraph note below the table. � Timeliness percentage for ADR/SAE Reporting is the percent of follow-up data submitted as of January 31 of the project year (December 31 for project year 5) with a 6-month grace period. � Disciplinary actions imposed by the Group during the current funding period should be described and explained in a brief paragraph note below the table (e.g., # of sites placed on probation for auditing or other issues). Page 203 of 241
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NCTN Program Guidelines Table of Co
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PART 1: Overview of NCTN Program Se
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Page 189 and 190: TYPE OF STUDY PART 3: Submission No
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Page 239 and 240: Part 4: Summary of Updates to Guide
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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