Data and Safety Monitoring

希望之城(COH)的数据和安全监测(DSM)的目标是监督临床试验 在希望之城综合癌症中心进行独立于人体受试者的保护 由COH机构审查委员会(IRB)提供，通过 通过癌症方案审查和监测委员会的方案审查和监测系统 (CPRMC)。这项职能是围绕癌症中心的数据和安全监测委员会组织的 (Dsmb)。Dsmb的主要作用是审查所有特定于协议的数据和安全监控计划， 来自方案管理团队的定期报告、偏差报告和不良事件报告 调查人员正在提交他们的报告，以确定这些毒性对行为的科学影响 它们发生的临床试验。此外，dsmb定期审查对正在进行的、高风险、 符合联邦法规和良好临床实践(GCP)的机构癌症临床试验 指导方针。临床研究质量保证办公室(OCRQA)的工作人员完成这两项工作 作为机构临床研究质量的一部分，对正在进行的内部研究进行详细审计 保证计划以及提供所有癌症临床操作中的偏差的有效报告 可能发生的审判。这一级别的审查提供了一种独立的手段来确认 癌症中心正在进行的研究性治疗计划。需求侧管理年度预算总额(5.42 FTE)为450,592美元；CCSG申请的资金为59,749美元，占总额的13%。

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.