NCI National Clinical Trials Network (NCTN) Program Guidelines

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Cancer Site *** etc. PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications Table 9. Operational Timelines for Trial Conduct by Major Cancer Category & Trial Phase/# Sorted by Major Cancer Category, Start Date, and Trial # from MM/DD/YYYY to MM/DD/YYYY (Include only trials open during the past 5-6 year period that are still accruing patients or that are temporarily closed to accrual and/or treatment) Cancer Site *** etc. Trial Phase LOI or Concept Trial Number & Brief Title Date Study Open for Patient Accrual* Trial Status (Open or Temporarily Closed to Accrual and/or Tx) Sample Size Accrual to Date % Projected Monthly Accrual Rate Estimated Study Closure Date (i.e., Closed to Accrual) Anticipated Primary Completion Date ** *For studies with the initial LOI/Concept submitted prior to 4/1/2010, use the date of activation of the trial for the “Date Study Open for Patient Accrual” column in the table. For studies with the initial LOI/Concept submitted after 4/1/2010, the NCI/DCTD OEWG definition used to define the date the study was open for patient enrollment should be used for this column in the table. ** Anticipated primary completion date follows the definition used for the NCI Clinical Trials Reporting Program (CTRP) and www.clinicaltrials.gov. *** For major cancer categories, use the same categories that are used for Tables #6 and #7 on pages 197 and 198, respectively. Table 10. Operational Timelines for Trial Completion by Major Cancer Category & Trial Phase/# Sorted by Major Cancer Category, Start Date, and Trial # from MM/DD/YYYY to MM/DD/YYYY (Include only trials closed to accrual during the past 5-6 year period) Trial Phase Trial Number & Brief Title Date Study Open for Patient Accrual Date Study Closed Sample Size Total Accrual Anticipated Primary Completion Date ** Results Reporting Date for CTRP/FDAAA Publication Submission Date Publication Date Publication Reference Comments *For studies with the initial LOI/Concept submitted prior to 4/1/2010, use the date of activation of the trial for the “Date Study Open for Patient Accrual” column in the table. For studies with the initial LOI/Concept submitted after 4/1/2010, the NCI/DCTD OEWG definition used to define the date the study was open for patient enrollment should be used for this column in the table. ** Anticipated primary completion date follows the definition used for the NCI Clinical Trials Reporting Program (CTRP) and www.clinicaltrials.gov. *** For major cancer categories, use the same categories that are used for Tables #6 and #7 on pages 197 and 198, respectively. Page 200 of 241
Participating Site Member Category Main Members Affiliates of Main Members CCOPs & MB-CCOPs CCOP and MB-CCOP Components Other Membership Categories (Describe) PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications Table 11. Summary of Onsite Auditing Activity for Clinical Trials Over 3-Year Period (2009-2011) --- THIS IS A SUMMARY TABLE ONLY. DO NOT INCLUDE SITE SPECIFIC INFORMATION. Table is based on # of audits performed by applicant for its member institutions over a 3-year period. The NCI-CTMB Guidelines for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Cancer Trials Support Unit (CTSU) require all Participating Sites to be audited at least once every 36 months. Each Group should conduct a comprehensive review of its membership and provide in its competing continuation and non-competing applications (i.e., Type 2 and Type 5 applications) an accounting for all Participating Sites in tabular format summarized by member category only (not by individual site). Audit specific information for particular participating sites will be requested for Type 5 applications with a specific format in a future update to these Guidelines. Network Group Operation Center applicants should complete the table below to summarize their auditing activities over the 3-year period from 2009 to 2011. The table below should be modified to reflect the membership categories of the applicant Group. *Sites that are terminated or withdrawn within 3-Yr period & later re-activated should still be counted in these columns. # ACTIVE Participating Sites with Separate NCI Institution Codes as of Date Table Prepared # Participating Sites TERMINATED Over 3-Year Period (2009-2011)* # Participating Sites WITHDRAWN Over 3-Year Period (2009-2011)* Audit Category # Routine Audits Performed & % Routine Audits with Specific Ratings by Audit Category Over 3-Yr Period (2009 – 2011) # Routine Audits % Acceptable % Acceptable with Follow-Up % Unacceptable # Re-Audits & Off-Cycle Audits Performed and % Re-Audits & Off-Cycle Audits with Specific Ratings by Audit Category Over 3-Yr Period (2009 – 2011) Audit Category IRB/ICC IRB/ICC Pharmacy Pharmacy Patient Cases Patient Cases IRB/ICC IRB/ICC Pharmacy Pharmacy Patient Cases Patient Cases IRB/ICC IRB/ICC Pharmacy Pharmacy Patient Cases Patient Cases IRB/ICC IRB/ICC Pharmacy Pharmacy Patient Cases Patient Cases IRB/ICC IRB/ICC Pharmacy Pharmacy Patient Cases Patient Cases # Re- Audits & Off-Cycle Audits % Acceptable % Acceptable with Follow-Up Page 201 of 241 % Unacceptable
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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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PART 1: Overview of the NCTN Progra
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PART 2: Submission of Competing New
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PART 2: Submission of New/Competing
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Page 149 and 150: PART 2: Submission of New/Competing
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Page 189 and 190: TYPE OF STUDY PART 3: Submission No
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Page 237 and 238: Part 4: Appendices - VII. Accrual I
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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