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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 1: Overview of <strong>NCTN</strong> <strong>Program</strong> Section III – General Management & <strong>Network</strong> Operating/Funding Principles<br />

III. General Management & <strong>Network</strong> Operating and Funding Principles<br />

A. General Management<br />

Direct programmatic oversight of the <strong>NCTN</strong> <strong>Program</strong> is provided by the <strong>NCI</strong> Division of Cancer Treatment and<br />

Diagnosis (DCTD) and its programs. The Chief of the <strong>Clinical</strong> Investigations Branch within the Cancer Therapy<br />

and Evaluation <strong>Program</strong> (CTEP), DCTD, <strong>NCI</strong> is the Lead <strong>Program</strong> Director of the <strong>NCTN</strong> <strong>Program</strong>. The Lead<br />

<strong>Program</strong> Director works with the Co-<strong>Program</strong> Directors for the key components of the <strong>NCTN</strong> <strong>Program</strong> from the<br />

Biometric Research Branch, the Cancer Diagnosis <strong>Program</strong>, the Cancer Imaging <strong>Program</strong>, and the Radiation<br />

Research <strong>Program</strong> as well as other <strong>NCI</strong> Senior Scientific and Administrative staff from all the branches within<br />

CTEP, other DCTD and <strong>NCI</strong> programs and offices, and the <strong>NCI</strong>/DCTD Senior <strong>Program</strong> Specialist to oversee the<br />

<strong>NCTN</strong> <strong>Program</strong>.<br />

<strong>NCI</strong>/DCTD staff involved with the <strong>NCTN</strong> <strong>Program</strong> also work closely with <strong>NCI</strong> staff from the Division of Cancer<br />

Prevention (DCP), especially DCP program staff for the Community <strong>Clinical</strong> Oncology <strong>Program</strong> (CCOP) and the<br />

Minority-Based CCOP (MB-CCOP) <strong>Program</strong>, to manage the <strong>NCTN</strong> <strong>Program</strong> as the CCOPs and MB-CCOPs<br />

participate directly in the clinical trials of the <strong>NCTN</strong> and the <strong>Network</strong> Groups of the <strong>NCTN</strong> also can serve as<br />

Research Bases for the CCOP program. General information on DCTD, DCP, and the programs involved in the<br />

direct programmatic oversight as well as the scientific and administrative activities of the <strong>NCTN</strong> <strong>Program</strong> is<br />

available from the <strong>NCI</strong> public website at the URLs listed below:<br />

<strong>NCI</strong> Division of Cancer Treatment and Diagnosis (DCTD): http://dctd.cancer.gov/<br />

<strong>NCI</strong>/DCTD Cancer Therapy Evaluation <strong>Program</strong> (CTEP): http://ctep.cancer.gov/<br />

<strong>NCI</strong>/DCTD Biometric Research <strong>Program</strong> (BRB): http://brb.nci.nih.gov/<br />

<strong>NCI</strong>/DCTD Cancer Diagnosis <strong>Program</strong> (CDP): http://dctd.cancer.gov/<strong>Program</strong>Pages/cdp/default.htm<br />

<strong>NCI</strong>/DCTD Cancer Imaging <strong>Program</strong> (CIP): http://imaging.cancer.gov/<br />

<strong>NCI</strong>/DCTD Radiation Research <strong>Program</strong> (RRP): http://rrp.cancer.gov/<br />

<strong>NCI</strong> Division of Cancer Prevention (DCP): http://prevention.cancer.gov/<br />

<strong>NCI</strong>/DCP Community <strong>Clinical</strong> Oncology <strong>Program</strong> (CCOP) and Minority-Based CCOP (MB-CCOP):<br />

http://prevention.cancer.gov/programs-resources/programs/ccop<br />

External strategic oversight of the <strong>NCTN</strong> <strong>Program</strong> is provided by the <strong>NCI</strong> <strong>Clinical</strong> <strong>Trials</strong> and Translational<br />

Research Advisory Committee (CTAC), especially the Strategic Planning Subcommittee of CTAC. Internal<br />

strategic oversight of the <strong>NCTN</strong> <strong>Program</strong> is provided by the <strong>NCI</strong> <strong>Clinical</strong> and Translational Research Operations<br />

Committee (CTROC). These programs are described in Part 1 – Section I.D.7.5 of these <strong>Guidelines</strong>.<br />

B. <strong>NCTN</strong> Leadership Management Committee<br />

The <strong>NCTN</strong> Leadership Management Committee is composed of key members of <strong>NCI</strong>/DCTD and <strong>NCI</strong>/DCP<br />

involved in the direct programmatic oversight of the <strong>NCTN</strong> <strong>Program</strong> and the Senior Leaders of the <strong>Network</strong><br />

Group Operations Centers, the <strong>Network</strong> Group Statistics and Data Management Centers, the <strong>Network</strong><br />

Radiotherapy and Imaging Core Services Centers, and the Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong><br />

involved in the direct management of clinical trials and support services. This management committee makes<br />

key recommendations regarding the policies, procedures, and conduct of the <strong>NCTN</strong> <strong>Program</strong> to the <strong>NCI</strong> as<br />

described in Part 1 – Section IV.D.4. of these <strong>Guidelines</strong>). The goal is for the <strong>NCI</strong>/DCTD and extramural <strong>NCTN</strong><br />

senior leadership to work collaboratively in managing the <strong>Program</strong>.<br />

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