Data and Safety Monitoring

数据和安全监控

基本信息

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
项目类别：
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

项目摘要

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.

希望之城 (COH) 数据和安全监测 (DSM) 的目标是对临床试验进行监督在希望之城综合癌症中心进行，独立于对人类受试者的保护通过 COH 机构审查委员会 (IRB) 提供，并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）。该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，方案管理团队的定期报告、偏差报告和不良事件报告研究人员提交以确定这些毒性对实验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、机构癌症临床试验符合联邦法规和良好临床实践 (GCP) 指导方针。临床研究质量保证办公室 (OCRQA) 的工作人员同时履行这两项职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审核保证计划以及提供所有癌症临床行为偏差的有效报告可能发生的试验。这一级别的审查提供了确认有效性的独立方法癌症中心正在进行的研究性治疗计划。帝斯曼年度预算总额（5.42 FTE）为 450,592 美元； CCSG 请求资金为 59,749 美元，占总额的 13%。