NCI National Clinical Trials Network (NCTN) Program Guidelines

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!
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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
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