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 />
PART 1: OVERVIEW OF THE <strong>NCTN</strong> PROGRAM ...................................................................................................................... 14<br />
I. INTRODUCTION ................................................................................................................................................................ 14<br />
A. Purpose and Content of <strong>Guidelines</strong> ......................................................................................................................... 14<br />
B. Background, Overview, and Purpose of the <strong>NCTN</strong> <strong>Program</strong>.................................................................................... 14<br />
C. Overall Goal of the <strong>NCTN</strong> <strong>Program</strong> ......................................................................................................................... 15<br />
D. Anticipated Organization of Key Components of the <strong>NCTN</strong> <strong>Program</strong> ...................................................................... 15<br />
1. <strong>Network</strong> Group Operations Centers .......................................................................................................................................16<br />
2. <strong>Network</strong> Group Statistics and Data Management Centers .....................................................................................................16<br />
3. <strong>Network</strong> Group Integrated Translational Science Centers ......................................................................................................17<br />
4. <strong>Network</strong> Lead Academic Participating Sites ...........................................................................................................................17<br />
5. <strong>Network</strong> Radiotherapy and Imaging Core Services Centers ....................................................................................................17<br />
6. Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> ......................................................................................................................17<br />
7. Interactions with Other <strong>NCI</strong>-supported <strong>Program</strong>s ..................................................................................................................17<br />
7.1 <strong>NCI</strong> <strong>Clinical</strong> <strong>Trials</strong> Tumor Banks................................................................................................................................................. 17<br />
7.2 <strong>NCI</strong> Community <strong>Clinical</strong> Oncology <strong>Program</strong>s (CCOPs) & Minority-Based CCOPs (MB-CCOPs).................................................. 18<br />
7.3 <strong>NCI</strong> Cancer <strong>Trials</strong> Support Unit (CTSU) ...................................................................................................................................... 18<br />
7.4 <strong>NCI</strong> Central Institutional Review Boards (CIRBs) ....................................................................................................................... 19<br />
7.5 <strong>NCI</strong> Advisory & Scientific Committees ...................................................................................................................................... 19<br />
7.5.1 <strong>NCI</strong> <strong>Clinical</strong> <strong>Trials</strong> and Translational Research Advisory Committee (CTAC) ..................................................................... 20<br />
7.5.2 <strong>NCI</strong> Scientific Steering Committees (SSCs) ....................................................................................................................... 20<br />
7.5.3 <strong>NCI</strong> <strong>Clinical</strong> and Translational Research Operations Committee (CTROC) ........................................................................ 20<br />
II. GOALS OF <strong>NCTN</strong> RESEARCH ............................................................................................................................................... 22<br />
A. <strong>Clinical</strong> Treatment <strong>Trials</strong> & Advanced Imaging <strong>Trials</strong> .............................................................................................. 22<br />
B. Ancillary Studies ..................................................................................................................................................... 22<br />
C. Cancer Control, Symptom Management, Prevention, and Quality of Life Studies ................................................... 22<br />
D. Collaborations Among <strong>Network</strong> Group and with Other Organizations on <strong>Clinical</strong> <strong>Trials</strong> ......................................... 23<br />
E. <strong>NCTN</strong> <strong>Clinical</strong> <strong>Trials</strong> Originating from Outside the <strong>Network</strong> Groups ........................................................................ 23<br />
F. Conduct of <strong>NCTN</strong> <strong>Clinical</strong> Research ......................................................................................................................... 23<br />
III. GENERAL MANAGEMENT & NETWORK OPERATING AND FUNDING PRI<strong>NCI</strong>PLES .............................................................................. 24<br />
A. General Management ............................................................................................................................................ 24<br />
B. <strong>NCTN</strong> Leadership Management Committee ............................................................................................................ 24<br />
C. <strong>Network</strong> Operating Principles ................................................................................................................................ 25<br />
1. Access to <strong>NCTN</strong> <strong>Trials</strong> & Crediting for Patients Accrual to <strong>Trials</strong> .............................................................................................25<br />
2. Submission of Data and Biospecimens for <strong>NCTN</strong> <strong>Trials</strong> ...........................................................................................................25<br />
3. Use of the <strong>NCI</strong> Central Institutional Review Board .................................................................................................................25<br />
4. Trial Proposals Originating From Outside the <strong>Network</strong> Groups ..............................................................................................26<br />
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