NCI National Clinical Trials Network (NCTN) Program Guidelines

NCTN Program Guidelines Table of Contents
3. Appendix Material & Post Submission Materials ................................................................................................................. 136
4. Just-in-Time Information ..................................................................................................................................................... 136
4.1 Other Support for Key Personnel ........................................................................................................................................... 136
4.2 Training on Human Subjects Protection for Key Personnel.................................................................................................... 136
5. Applications for New Network Lead Academic Participating Sites ....................................................................................... 137
F. Network Radiotherapy & Imaging Core Services Centers Application ................................................................... 138
1. Detailed Budget for Initial Budget Period ............................................................................................................................. 138
2. Research Plan ...................................................................................................................................................................... 139
2.1 Sub-section A. Network Radiotherapy and Imaging Core Services Centers Overview ......................................................... 140
2.2 Sub-section B. Radiotherapy Core Services Center ............................................................................................................... 141
2.3 Sub-Section C. Imaging Core Services Center ........................................................................................................................ 141
2.4 Sub-section D. Program for Collaborations and Participation in Collective Management ................................................... 141
2.5 Protection of Human Subjects ............................................................................................................................................... 142
2.6 Resource Sharing Plans .......................................................................................................................................................... 142
3. Appendix Material & Post Submission Materials ................................................................................................................. 143
4. Just-in-Time Information ..................................................................................................................................................... 143
4.1 Other Support for Key Personnel ........................................................................................................................................... 143
4.2 Training on Human Subjects Protection for Key Personnel.................................................................................................... 143
4.3 List of Legacy Trials ................................................................................................................................................................ 143
G. Canadian Collaborating Clinical Trials Network Application ................................................................................. 144
1. Detailed Budget for the Initial Budget Period....................................................................................................................... 144
2. Research Plan ...................................................................................................................................................................... 144
2.1 Sub-section A. Operations, Statistics, and Data Management Center Overview .................................................................. 144
2.2 Sub-section B. Clinical Trial Development & Member Site Accrual Program ........................................................................ 145
2.3 Sub-section C. Operational Management ............................................................................................................................. 146
2.4 Sub-section D. Statistics Analysis Program and Data Management ...................................................................................... 147
2.5 Sub-section E. Program for Collaborations and Participation in Collective Management .................................................... 148
2.6 Protection of Human Subjects ............................................................................................................................................... 148
2.7 Resource Sharing Plans .......................................................................................................................................................... 148
3. Appendix Material & Post Submission Materials ................................................................................................................. 149
4. Just-in-Time Information ..................................................................................................................................................... 149
4.1 Other Support for Key Personnel ........................................................................................................................................... 149
4.2 Training on Human Subjects Protection for Key Personnel.................................................................................................... 149
4.3 Onsite Auditing Activities ....................................................................................................................................................... 149
4.4 Provision of Funds to Member Institution/Sites for Per Patient Data Management & List of Legacy Trials ......................... 150
4.5 Data and Safety Monitoring Boards/Plans ............................................................................................................................. 150
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