课题基金 / 基金详情

Core--clinical

Core--clinical
核心--临床
批准号:
6365595
负责人:
BERTIL E GLADER
金额:
$24.87万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2000
资助国家:
美国
项目状态:
已结题
起止时间:
2000-09-28 至 2005-08-31

项目摘要

项目成果

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中文摘要
翻译
临床核心的目标是:(1)协助临床试验设计;(2)维护适当的监管基础设施,并确保地方、州和联邦各级对拟议和未来的临床试验的合规性;(3)与私营CRO和国家PEGT数据管理专家进行接口和数据传输。三项临床试验的患者将在斯坦福大学或费城儿童医院接受治疗。虽然记录保存最终将由患者接受治疗的中心负责,但斯坦福大学将作为领导中心,通过Core维护试验的整体组织框架。虽然斯坦福大学的GCRC将作为临床核心的实际地点,但这两个机构的参与者都有代表。以下是对斯坦福大学的GCRC的描述和对CHOP的GCRC的简要概述。临床核心的职责在此进行了描述。
英文摘要
The goal of the Clinical Core is to: (1) assist in clinical trial design; (2) maintain the appropriate regulatory infrastructure and ensure compliance at the local, state, and federal levels for proposed and future clinical trials; (3) interface and data transfer to the private CRO and National PEGT data management specialists. Patients in three clinical trials will be treated at Stanford University or The Children's Hospital of Philadelphia. While record keeping will ultimately be the responsibility of the center in which the patient is treated, Stanford University will serve as the lead Center for maintaining the overall organizational framework of the trials through the Core. While the GCRC at Stanford University will serve as the physical site of the Clinical Core, participants from both institutions are represented. A description of the GCRC at Stanford and a brief summary of the GCRC at CHOP follows. The duties of the clinical core is described herein.
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  • 项目类别:
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  • 财政年份:
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  • 负责人:
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  • 依托单位:
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  • 项目类别:
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  • 财政年份:
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  • 负责人:
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  • 依托单位:
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