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CORE--CLINICAL TRIAL PROTOCOL REVIEW/MONITORING SYSTEM

CORE--CLINICAL TRIAL PROTOCOL REVIEW/MONITORING SYSTEM
核心——临床试验方案审查/监测系统
批准号：
6599281
负责人：
CARLOS J CARRERA
金额：
$18.37万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
项目状态：
已结题
起止时间：
2002-06-11 至 2003-04-30
来源：
https://reporter.nih.gov/project-details/6599281
关键词：
biomedical facility clinical trials experimental designs health care service evaluation health services research tag human data neoplasm /cancer neoplasm /cancer therapy

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中文摘要
翻译
描述：这个系统要求癌症中心有一个委员会
英文摘要
Description: This required system for cancer centers has a committee composed of ten members and the unit is headed by Carlos Carrera, M.D. The committee has statistical and primarily clinical representation, with ad hoc additional basic scientist reviewers. There are 4 aims which include providing peer review of all cancer-related clinical protocols; review of protocol progress; authorization of continuation or discontinuation of protocols and prioritize protocols by discipline through the Specialized Cancer Units. From May 1999 through February 2000, the PRMS reviewed 87 protocols, 58 NCI, 16 institutional, and 13 from pharmaceutical companies. The PRMS has 4 categories of decisions: Approval, Approved Pending IND, Approved Pending Clarification, and Deferred. Monitoring is provided for informed consent (Level 1), for accrual (Level 2), and for in-depth monitoring (Level 3). The Chair, Dr Carlos Carrera, continues in his role from the prior submission.
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CORE--CLINICAL TRIAL PROTOCOL REVIEW/MONITORING SYSTEM
CORE--CLINICAL TRIAL PROTOCOL REVIEW/MONITORING SYSTEM
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