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 />
III. DESCRIPTION OF REVIEW PROCESS AND REVIEW CRITERIA FOR NEW AND COMPETING APPLICATIONS ............................................... 151<br />
A. General Information ............................................................................................................................................. 151<br />
1. Role of Peer Review and Review Policies ............................................................................................................................. 151<br />
2. Application Receipt and Referral Process ............................................................................................................................. 152<br />
3. Application Administrative Review ...................................................................................................................................... 152<br />
4. Review Format .................................................................................................................................................................... 152<br />
5. Selection of Reviewers ........................................................................................................................................................ 153<br />
B. Review Criteria ..................................................................................................................................................... 154<br />
1. General Information on Review Criteria and Evaluation for All Key Components of the <strong>NCTN</strong> ............................................. 154<br />
2. Specific Review Criteria for Each of the Key Components of the <strong>NCTN</strong> ................................................................................. 155<br />
2.1 Criteria for <strong>Network</strong> Group Operations Center ...................................................................................................................... 155<br />
2.1.1 Overall Impact - Overall ................................................................................................................................................. 155<br />
2.1.2 Scored Review Criteria – Overall ................................................................................................................................... 155<br />
2.1.3 Scored Review Criteria – Criterion A. <strong>Clinical</strong> Trial Development <strong>Program</strong> .................................................................. 156<br />
2.1.4 Scored Review Criteria – Criterion B. Member Site Accrual <strong>Program</strong>........................................................................... 158<br />
2.1.5 Scored Review Criteria – Criterion C. Operational Management ................................................................................. 158<br />
2.1.6 Scored Review Criteria – Criterion D. <strong>Program</strong> for Collaboration & Participation in Collective Management ............. 160<br />
2.2 <strong>Network</strong> Group Statistics and Data Management Center Review Criteria ............................................................................. 161<br />
2.2.1 Overall Impact - Overall ................................................................................................................................................. 161<br />
2.2.2 Scored Review Criteria – Overall ................................................................................................................................... 161<br />
2.2.3 Scored Review Criteria – Criterion A. Statistical Analysis <strong>Program</strong> & Collaborative Research & Collective Mgt ........ 162<br />
2.2.4 Scored Review Criteria – Criterion B. Data Management <strong>Program</strong> .............................................................................. 163<br />
2.3 <strong>Network</strong> Group Integrated Translational Science Support Center Review Criteria ............................................................... 165<br />
2.3.1 Overall Impact - Overall ................................................................................................................................................. 165<br />
2.3.2 Scored Review Criteria – Overall ................................................................................................................................... 165<br />
2.3.3 Additional Review Item A – Integrated Translational Science <strong>Program</strong> ........................................................................ 166<br />
2.3.4 Additional Review Item B – Pilot Studies and Collaborative Projects ............................................................................ 167<br />
2.4 Lead Academic Participating Site Review Criteria .................................................................................................................. 168<br />
2.4.1 Overall Impact - Overall ................................................................................................................................................. 168<br />
2.4.2 Scored Review Criteria – Overall ................................................................................................................................... 168<br />
2.4.3 Scored Review Criteria – Criterion A. <strong>Clinical</strong> Trial <strong>Program</strong> ......................................................................................... 169<br />
2.4.4 Scored Review Criteria – Criterion B. Site Accrual <strong>Program</strong> ......................................................................................... 170<br />
2.5 <strong>Network</strong> Radiotherapy and Imaging Core Services Centers Review Criteria .......................................................................... 172<br />
2.5.1 Overall Impact - Overall ................................................................................................................................................. 172<br />
2.5.2 Scored Review Criteria – Overall (Including <strong>Program</strong> for Collaborations & Participation in Collective Management) . 172<br />
2.5.3 Scored Review Criteria – Criterion A. Radiotherapy Core Services Center <strong>Program</strong> .................................................... 174<br />
2.5.4 Scored Review Criteria – Criterion B. Imaging Core Services Center <strong>Program</strong> ............................................................. 175<br />
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