NCI National Clinical Trials Network (NCTN) Program Guidelines

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NCTN Program Guidelines Table of Contents II. SUGGESTED FORMATS - TABLES FOR NEW & NON-COMPETING APPLICATIONS ............................................................................ 195 A. Network Group Operations Centers & Canadian Collaborating Clinical Trials Network ........................................ 195 Table 1. Key Leadership Staffing .............................................................................................................................................. 195 Table 2. Primary Scientific Achievements for Trials by Disease Area, Trial Phase, & Trial # ....................................................... 195 Table 3. Other Important Achievements for Trials by Disease Area, Trial Phase, & Trial # ........................................................ 196 Table 4. List of Approved Applications for Use of “Banked” Biospecimens from Applicant Clinical Trials .................................. 196 Table 5. Summary Accrual for All Clinical Trials (All Cancers) by Trial Phase by Members of the Applicant Network Group ...... 196 Table 6. Summary Accrual By Major Cancer Category & Trial Phase by Members of Applicant Network Group ....................... 197 Table 7. Summary Accrual By Major Cancer Category and Trial Phase to All Trials Led by Applicant Network Group ................ 198 Table 8. Operational Timelines for Development of Trial Proposals Sorted by Major Cancer Category, Start Date, & Trial # .... 199 Table 9. Operational Timelines for Trial Conduct by Major Cancer Category & Trial Phase/#.................................................... 200 Table 10. Operational Timelines for Trial Completion by Major Cancer Category & Trial Phase/# ............................................ 200 Table 11. Summary of Onsite Auditing Activity for Clinical Trials .............................................................................................. 201 B. Network Group Statistics & Data Management Centers & Canadian Collaborating Clinical Trials Network ........ 202 Table 1. Key Leadership Staffing for the SDMC ......................................................................................................................... 202 Table 2. Summary of General Data Timelines for Open Studies ................................................................................................ 202 Table 3. Summary of Data Quality and Data Timeliness – Serious AE Reporting ....................................................................... 203 C. Network Lead Academic Participating Sites ........................................................................................................ 204 Table 1. Key Leadership Staffing .............................................................................................................................................. 204 Table 2. Primary Scientific Achievements for Trials by Major Cancer Category, Trial Phase, & Trial # ....................................... 204 Table 3. Other Important Achievements for Trials by Major Cancer Category, Trial Phase, & Trial # ........................................ 205 Table 4. List of Approved Applications for Use of “Banked” Biospecimens from Phase 2 and Phase 3 Clinical Trials ................ 205 Table 5. Summary Accrual for All Clinical Trials for All Cancers by Trial Phase .......................................................................... 206 Table 6. Summary Accrual by Applicant Components by Major Cancer Category and Trial Phase ............................................. 207 Table 7. Summary Accrual by Major Cancer Category and Trial Phase to All Trials.................................................................... 208 Table 8. Operational Timelines for Activation of Clinical Trial Proposals at Academic Participating Site Applicant ................... 208 D. Network RT & Imaging Core Services Centers ...................................................................................................... 209 Table 1. Summary of Clinical Trials Using RT Core Services by Major Cancer Category, Trial Phase, & Trial # ............................ 209 Table 2. Summary of Clinical Trials Using Imaging Core Services by Major Cancer Category, Trial Phase, & Trial #.................... 209 III. SCHEMA OF NCI/DCTD STUDY PROPOSAL REVIEW/EVALUATION ............................................................................................ 210 IV. COST COMPONENTS FOR BUDGET PREPARATION FOR NETWORK GROUP OPERATIONS CENTERS AND SDMCS, NETWORK LEAD ACADEMIC PARTICIPATING SITES, AND CANADIAN COLLABORATION CLINICAL TRIALS NETWORK NEW APPLICATIONS ........................................ 211 A. Guidelines for General Budget Inputs for Estimating Total Cost Budget Requests – Type 1 Application ............... 211 B. Guidelines for Estimating Total Cost Budget Request for Adult Ops Center, SDMC & Canadian Network .......... Error! Bookmark not defined. C. Guidelines for Estimating Total Cost Budget Request for Pediatric Ops Center and SDMC .................................. 2123 D. Guidelines for Estimating Total Cost Budget Request for Network Lead Academic Participating Sites ................. 215 Page 12 of 241
NCTN Program Guidelines Table of Contents V. OTHER IMPORTANT NCI/NIH URLS, FEDERAL CITATIONS, AND LIST OF ABBREVIATIONS ............................................................... 216 A. Website URLs referenced in these Guidelines ....................................................................................................... 216 B. Other Federal Citations for NIH Grants Involved in Human Subjects Research & Websites ................................... 218 C. Important Abbreviations Referenced in these Guidelines ..................................................................................... 220 VI. SAMPLE TABLE OF CONTENTS FOR PHS 398 APPLICATION (EXAMPLE: NETWORK GROUP OPERATIONS CENTER) ................................ 223 VII. MODEL FOR NCTN PROGRAM DATA SHARING POLICY FOR NETWORK GROUP OPS CENTERS & SDMCS ......................................... 224 VIII. NCTN PROGRAM DATA AND SAFETY MONITORING BOARD (DSMB) POLICY FOR PHASE 3 TRIALS & RANDOMIZED PHASE 2 TRIALS .. 227 IX. COMMON BUDGET OUTLINE FOR NETWORK GROUP OPERATIONS CENTER APPLICATIONS – SUGGESTED FORMAT ............................. 233 X. ACCRUAL INPUT BY MEMBER INSTITUTION/SITES FOR NETWORK GROUP OPERATIONS CENTER, CANADIAN COLLABORATING CLINICAL TRIALS NETWORK & LEAD ACADEMIC PARTICIPATING SITE APPLICATIONS .......................................................................................... 236 XI. LIST MEMBER INSTITUTIONS/PARTICIPATING SITES FOR NETWORK GROUPS/CANADIAN COLLABORATING NETWORK APPLICATIONS ... 2368 XII. SUMMARY OF UPDATES TO GUIDELINES DOCUMENT VERSION 1.1 (DATED 12/15/2012) REVISIONS LISTED BY PAGE # .......... 2369 Page 13 of 241
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TYPE OF STUDY PART 3: Submission No
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Participating Site Member Category
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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