课题基金 / 基金详情

Data and Safety Monitoring

Data and Safety Monitoring
数据和安全监控
批准号:
7714136
负责人:
THEODORE G KRONTIRIS
金额:
$4.24万
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 2012-11-30

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中文摘要
翻译
希望之城(COH)的数据和安全监测(DSM)的目标是为临床试验提供监督
英文摘要
The goal of Data and Safety Monitoring (DSM) at City of Hope (COH) is to provide oversight of clinical trials conducted at City of Hope Comprehensive Cancer Center independent of the protection of human subjects afforded through the COH Institutional Review Board (IRB) and the scientific review afforded through the Protocol Review and Monitoring System via the Cancer Protocol Review and Monitoring Committee (CPRMC). This function is organized around the Cancer Center's Data and Safety Monitoring Board (DSMB). The principal role of the DSMB is to review all protocol-specific data and safety monitoring plans, periodic reports from protocol management teams, deviation reports, and adverse event reports from investigators as they are submitted to determine the scientific impact of these toxicities on the conduct of the clinical trial in which they occurred. In addition, the DSMB regularly reviews audits of ongoing, high-risk, institutional cancer clinical trials for compliance with federal regulations and Good Clinical Practice (GCP) guidelines. Staff members of the Office of Clinical Research Quality Assurance (OCRQA) perform both detailed audits of ongoing in-house studies as part of the institution's clinical research quality assurance program as well as providing effective reporting of deviations in the conduct of all cancer clinical trials as they may occur. This level of review provides an independent means of confirming the efficacy of the investigational treatment programs ongoing in the Cancer Center. The total annual budget for DSM (5.42 FTEs) is $ 450,592; CCSG funding is requested for $ 59,749, or 13% of the total.
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