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: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714136
• 关键词: Accreditation; Adverse event; Advisory Committees; Amendment; Annual Reports; Area; Biometry; Biostatistics Core; Budgets; Cancer Center; Cancer Center Support Grant; Cities; City of Hope Comprehensive Cancer Center; Clinical Investigator; Clinical Practice Guideline; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Communities; Conduct Clinical Trials; Conflict of Interest; Data; Development; Education; Ensure; Evaluation; Funding; Goals; Guidelines; Head; Hematology; Housing; Information Sciences; Institution; Investigational New Drug Application; Investigational Therapies; Malignant Neoplasms; Medical Oncology; Monitor; Monitoring Clinical Trials; Office for Human Research Protections; Operative Surgical Procedures; Pediatrics; Pharmacy facility; Phase; Phase III Clinical Trials; Policies; Principal Investigator; Process; Protocols documentation; Regulation; Regulatory Affairs; Reporting; Research; Research Activity; Research Ethics Committees; Research Personnel; Research Subjects; Resources; Risk; Role; Safety; Schedule; Specialist; Standards of Weights and Measures; System; Toxic effect; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States National Institutes of Health; Update; cancer research center director; human subject; medical specialties; member; programs; quality assurance; technology development; treatment program

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.

City of Hope（COH）的数据和安全性监测（DSM）旨在监督临床试验 在City of Hope综合癌症中心进行，不受人类受试者保护 通过COH机构审查委员会（IRB）提供的科学审查， 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）。该功能是围绕癌症中心的数据和安全监测委员会组织的 （DSMB）。DSMB的主要职责是审查所有方案特定数据和安全性监查计划， 方案管理团队的定期报告、偏离报告和不良事件报告 研究人员，因为他们提交，以确定这些毒性的科学影响的行为， 临床试验中发生的。此外，DSMB定期审查正在进行的、高风险的、 符合联邦法规和药物临床试验质量管理规范（GCP）的机构癌症临床试验 指南临床研究质量保证办公室（OCRQA）的工作人员负责 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稽查 保证计划，并提供有效的偏差报告，在所有癌症临床 审判，因为他们可能会发生。这一级别的审查提供了一种独立的方法来确认 癌症中心正在进行的研究性治疗计划。电力需求侧管理年度总预算（5.42 FTE）为450，592美元; CCSG资金要求为59，749美元，占总额的13%。