NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 4: Appendices Section I – NCI/DCTD Policies for NCTN (URLs to Website Pages) Part 4: Appendices I. NCI/DCTD Policies for the NCTN Program (URLs to Websites) A. NCI National Clinical Trials Network Program (NCTN) Guidelines http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies B. Investigator’s Handbook (A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI) http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm C. NCI-CTMB Guidelines for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Cancer Trials Support Unit (CTSU) http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm D. IP Option Policy: http://ctep.cancer.gov/industryCollaborations2/default.htm#guidelines_for_collaborations http://ctep.cancer.gov/industryCollaborations2/default.htm E. Operational Efficiency Working Group (OEWG) Policy and Timelines: http://ctep.cancer.gov/SpotlightOn/OEWG.htm F. Policy on Contract Review http://ctep.cancer.gov/industryCollaborations2/guidelines.htm (Under NCI Standard Protocol Language for Collaborative Agreements) G. Early Stopping Guidelines for Slowly-Accruing Phase 3 Studies http://ctep.cancer.gov/protocolDevelopment/default.htm#cde_data_pol_cdus (Under CDE / Data policies / CDUS – Slow Accrual Guidelines for Phase 3 Trials) H. Adverse Event Expedited Reporting System (AdEERS) http://ctep.cancer.gov/protocolDevelopment/electronic_applications/adeers.htm http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf I. Information on Common Data Elements (CDE) Approved for Use in CTEP-sponsored Clinical Trials https://cabig.nci.nih.gov/community/concepts/caDSR/ J. NCI’s Common Terminology Criteria for Adverse Events (CTCAE) http://ctep.cancer.gov/reporting/ctc.html K. NCI Clinical Trials Cooperative Group Program Guidelines for the Development, Conduct and Analysis of Clinical Trials with International Collaborating Institutions (Under Guidelines & Policies) http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies L. CTEP Conflict of Interest Policy for Cooperative Group Phase 3 Clinical Trials (Under Guidelines and Policies) http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies M. NCI Templates for Simplified Model Informed Consent Documents for NCTN Trials http://cancer.gov/clinicaltrials/patientsafety/simplification-of-informed-consent-docs/page3 Page 194 of 241
PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications II. Suggested Formats - Tables for New & Non-Competing Applications Current and/or relevant information in the past 5-6 years should be used in the tables unless otherwise indicated. Suggested reporting period over past 5-6 years for all tables requested for the application, unless otherwise indicated, is January 1, 2007 thru June 30, 2012. A. Network Group Operations Centers & Canadian Collaborating Network List of Tables with Suggested Formats Network Group Operations Center applicants should include key leadership, scientific achievements, accrual, and other information (e.g., operational efficiency timelines) 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 accrual and other 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 (not industry, investigator-initiated, or early phase trials). Accrual tables are for cancer treatment trials only; if applicant wishes to emphasize significant past accrual on 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 the NCI Cooperative Group Program, that information can be presented in the text of Research Plan under “Member Site Accrual Program.” Leadership, scientific achievement, and other information from DCTD-sponsored Cooperative Group primary advanced imaging studies can be included in the appropriate non-accrual tables with achievements from treatment trials. Canadian Collaborating Clinical Trial Network applicants can also include 1 separate accrual table (modified Table 7) to show treatment trial accrual for trials they lead for their own organization to highlight their potential for accrual across a range of diseases; however, this table must be clearly labeled as accrual distinct from the accrual tables on their past participation in NCI Cooperative Group Program. Table 1. Key Leadership Staffing of Network Group As of Date Application Preparation: MM/DD/YYYY This table should reflect current positions in the Network Group held by investigators with institutional affiliation as of date this table was prepared for inclusion in application. Please Note: For key positions by Network Group investigators in NCI Scientific Steering Committees, task forces & working Groups, NCI CIRBs, etc., that information should be provided in the text of the “Program for Collaboration & Participation in Collective Management” of Research Plan for Operations Center (see page 111 on research plan & page 160 on review criteria) & Canadian Collaborating Network applications (see page 148 research plan & page 182 review criteria). Staffing Category for Network Group Operations Center Executive or Oversight Committee (All members should be listed) Data and Safety Monitoring Board or Data Monitoring Committee (All members should be listed) Scientific Committee #1 (List Chair and Vice-Chair(s) of the overall scientific committee only – Do not include subcommittee heads) Administrative Committee #1 (List Chair and Vice-Chair(s) of the overall administrative committee only – Do not include subcommittee heads) ETC. Chair Member Status Member Name Title Institution Vice-Chair Members ……. Chair Vice-Chair Members ……. Chair Vice-Chair Vice-Chair Chair Vice-Chair Vice-Chair Length of Service in Position Table 2. Important, Primary Scientific Achievements for Trials by Disease Area, Trial Phase, & Trial # from MM/DD/YYYY to MM/DD/YYYY (Include important, primary scientific achievements that were reported only in the past 5-6 years) - Please Note: The primary scientific achievement refers to the Primary Endpoint(s) for the trial specified in the protocol document. Applicants should briefly explain the importance of the achievement regardless of whether the results were positive or negative as it is the importance of the achievement that is the focus of the table for reviewers, not number of publications. Cancer Site etc. Trial Phase Year (Publication or FDA Indication or Other) Trial Number & Brief Title Experimental Agent or Regimen Primary Endpoint Result - Indication Manuscript or Abstract Reference Incorporated into Practice Guidelines (Type Guidelines, Year)? FDA-Approved Labeling Indication or Other Important Impact (Describe)? Date Trial Activation Date Trial Closed to Accrual Total Accrual Page 195 of 241
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Page 143 and 144: PART 2: Submission of New/Competing
Page 187 and 188: PART 3: Submission of Non-Competing
Page 189 and 190: TYPE OF STUDY PART 3: Submission No
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Page 197 and 198: PART 4: Appendices Section II - Req
Page 201 and 202: Participating Site Member Category
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Page 223 and 224: Part 4: Appendices - VI. Sample Tab
Page 225 and 226: Part 4: Appendices - VII. Model for
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Page 233 and 234: Part 4: Appendices - IX. Common Bud
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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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