Data and Safety Monitoring System
Data and Safety Monitoring System
批准号:
7698903
负责人:
Romnee Clark
金额:
$1.97万
依托单位国家:
美国
项目类别:
财政年份:
2008
资助国家:
美国
项目状态:
已结题
起止时间:
2008-09-01 至 2013-08-31
关键词:
Adverse eventCancer CenterClinical ResearchClinical TrialsClosureCommunitiesDataDisputesEnsureEventFundingGoalsIndustryMalignant NeoplasmsMonitorMonitoring Clinical TrialsOncology GroupOutcomePoliciesPrincipal InvestigatorProceduresProcessProtocol ComplianceProtocols documentationQuality ControlRecommendationReportingResearch PersonnelReview CommitteeSafetySiteSystemdexamethasone 21-palmitatepatient safetyquality assuranceresponse
中文摘要
ID西蒙癌症中心的数据和安全监控功能是主要的
临床试验监督委员会(CTMC)的职责。它的功能与之密切相关
科学审查委员会,该委员会评估所有与癌症相关的临床研究的科学价值
该中心的审判。
IUSCC临床试验监测委员会(CTMC)由Romnee Clark博士担任主席。这个
CTMC的主要职责是评估试验专用数据安全性的充分性
由SRC审查的每个议定书的监测计划(DMSP),以审查ILJSCC赞助的
患者安全研究,确保方案和不良事件报告的合规性,并进行
内部审计和质量保证审查。
临床研究委员会(CRC)由临时副主任凯西·米勒博士担任主席
临床研究,监督SRC和CTMC的政策和程序,每月收到
报告这些委员会的活动,并在发生争端时进行仲裁。
英文摘要
The Data and Safety Monitoring function of the ID Simon Cancer Center is the primary
responsibility of the Clinical Trials Monitoring Committee (CTMC). Its function is closely related to
the Scientific Review Committee, which evaluates the scientific merit of all cancer-related clinical
trials of the Center.
The IUSCC Clinical Trials Monitoring Committee (CTMC) is chaired by Dr. Romnee Clark. The
primary responsibilities of the CTMC are to assess the adequacy of trial-specific data safety
monitoring plans (DMSP's) for each protocol reviewed by the SRC, to review ILJSCC-sponsored
studies for patient safety, to ensure protocol and adverse event report compliance, and to conduct
internal audits and quality assurance reviews.
The Clinical Research Committee (CRC) chaired by Dr. Kathy Miller, Interim Associate Director for
Clinical Research, oversees the policies and procedures of the SRC and CTMC, receives monthly
reports of the activities of these committees, and arbitrates in the event of disputes.
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会议论文
Data and Safety Monitoring System
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批准号:8637217
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项目类别:
-
资助金额:$8.26万
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财政年份:1999
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负责人:Romnee Clark
-
依托单位:
Data and Safety Monitoring System
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批准号:8321648
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项目类别:
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资助金额:$3.12万
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财政年份:--
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负责人:Romnee Clark
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依托单位:
Data and Safety Monitoring System
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批准号:8381239
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项目类别:
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资助金额:$2.51万
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财政年份:--
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负责人:Romnee Clark
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依托单位:
Data and Safety Monitoring System
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批准号:8139251
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项目类别:
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资助金额:$3.73万
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财政年份:--
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负责人:Romnee Clark
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依托单位:
Data and Safety Monitoring System
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批准号:8710490
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项目类别:
-
资助金额:$0.54万
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财政年份:--
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负责人:Romnee Clark
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依托单位:
Data and Safety Monitoring System
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批准号:7921536
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项目类别:
-
资助金额:$3.46万
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财政年份:--
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负责人:Romnee Clark
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依托单位:
Data and Safety Monitoring System
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批准号:8727161
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项目类别:
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资助金额:$0.71万
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财政年份:--
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负责人:Romnee Clark
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依托单位:
海外基金