NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines
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<strong>NCTN</strong> <strong>Program</strong> <strong>Guidelines</strong> Table of Contents<br />
4. Just-in-Time Information ..................................................................................................................................................... 113<br />
4.1 Other Support for Key Personnel ............................................................................................................................................ 113<br />
4.2 Training on Human Subjects Protection for Key Personnel .................................................................................................... 113<br />
4.3 Onsite Auditing Activities ........................................................................................................................................................ 113<br />
4.4 Provision of Funds to Member Institution/Sites for Per Patient Data Management and Travel & List of Legacy <strong>Trials</strong> ........ 113<br />
4.5 Data and Safety Monitoring Boards/Plans and Updates ......................................................................................................... 114<br />
C. <strong>Network</strong> Group Statistics & Data Management Center Application .................................................................... 115<br />
1. Detailed Budget for Initial Budget Period ............................................................................................................................. 115<br />
2. Research Plan ...................................................................................................................................................................... 117<br />
2.1 Sub-section A. Statistics and Data Management Center Overview ...................................................................................... 118<br />
2.2 Sub-section B. Statistical Analysis <strong>Program</strong> & Collaborative Research and Collective Management ................................... 118<br />
2.3 Sub-section C. Data Management ......................................................................................................................................... 119<br />
2.4 Letter of Support from <strong>Network</strong> Group Operations Center ................................................................................................... 120<br />
2.5 Protection of Human Subjects ............................................................................................................................................... 120<br />
2.6 Resource Sharing Plans .......................................................................................................................................................... 121<br />
3. Appendix Material & Post Submission Materials .................................................................................................................. 121<br />
4. Just-in-Time Information ...................................................................................................................................................... 121<br />
4.1 Other Support for Key Personnel ........................................................................................................................................... 121<br />
4.2 Training on Human Subjects Protection for Key Personnel.................................................................................................... 122<br />
4.3 Data and Safety and Monitoring Boards/Plans Updates ........................................................................................................ 122<br />
D. <strong>Network</strong> Group Integrated Translational Science Center Application ................................................................. 123<br />
1. Detailed Budget for Initial Budget Period ............................................................................................................................. 123<br />
2. Research Plan ...................................................................................................................................................................... 124<br />
2.1 Sub-section A. Integrated Translational Science Center Overview ...................................................................................... 124<br />
2.2 Sub-Section B. Translational Science <strong>Program</strong> ...................................................................................................................... 125<br />
2.3 Sub-section C. Pilot Studies and Collaborative Projects ........................................................................................................ 125<br />
2.4 Letter of Support from <strong>Network</strong> Group Operations Center(s) and <strong>Network</strong> Group SDMCs .................................................. 125<br />
2.5 Protection of Human Subjects ............................................................................................................................................... 125<br />
2.6 Resource Sharing Plans .......................................................................................................................................................... 126<br />
3. Appendix Material & Post Submission Materials .................................................................................................................. 126<br />
4. Just-in-Time Information ...................................................................................................................................................... 126<br />
4.1 Other Support for Key Personnel ........................................................................................................................................... 126<br />
4.2 Training on Human Subjects Protection for Key Personnel.................................................................................................... 127<br />
E. <strong>Network</strong> Lead Academic Participating Site Application ....................................................................................... 128<br />
1. Detailed Budget for the Initial Budget Period ........................................................................................................................ 128<br />
1.1 Estimation of Total Cost Budget Request Based on Potential Accrual to <strong>NCTN</strong> <strong>Trials</strong> ............................................................ 128<br />
1.2 Budget Categories for Funding “Level of Effort” Total Cost Budget Request ......................................................................... 130<br />
1.3 Rationale for Budget Policy .................................................................................................................................................... 132<br />
1.4 Accrual Input by Academic Participating Site for Budget Request ......................................................................................... 133<br />
2. Research Plan ...................................................................................................................................................................... 133<br />
2.1 Sub-section A. Lead Academic Participating Site Overview .................................................................................................. 133<br />
2.2 Sub-section B. <strong>Clinical</strong> Trial <strong>Program</strong> .................................................................................................................................... 134<br />
2.3 Sub-section C. Site Accrual <strong>Program</strong> .................................................................................................................................... 135<br />
2.4 Letters of Support from <strong>Network</strong> Group Operations Centers and Affiliates…………………………………………………….………………. 135<br />
2.5 Protection of Human Subjects ............................................................................................................................................... 135<br />
2.6 Resource Sharing Plans .......................................................................................................................................................... 136<br />
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