Data and Safety Monitoring

数据和安全监控

• 批准号: 7491903
• 负责人: JAMES A STEWART
• 金额: $ 11.44万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-23 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7491903
• 关键词: Biometry; Clinical; Clinical Research; Clinical Trials; Data; Databases; Ensure; Generations; Medical Informatics; Medicine; Mission; Monitor; Policies; Procedures; Protocols documentation; Reporting; Research; Research Personnel; Review Committee; Safety; Severe Adverse Event; System; Toxic effect; Wisconsin; Work; experience; human subject; member; oncology; outreach; professor; quality assurance; response

The Data and Safety Monitoring System.(DSMS) of the UWCCC ensures that all clinical research being conducted under the auspices of the UWCCC is in compliance with federal requirements and most importantly that human subject safety is always optimized. The DSMS is assisted in its mission of safety and compliance by experienced UWCCC research staff, a Data and Safety Monitoring Committee (DSMC) composed of experienced clinical researchers, and the ongoing use of ONCORE database which allows more efficient tracking of protocols and protocol subjects. The DSMC reviews reports on quality assurance (internal audits, response reviews), protocol deviations and severe adverse events. The DSMC also provides data review, data abstraction and entry, forms monitoring and final report generation for studies developed and solely monitored by the UWCCC. The DSMC is chaired and co-chaired by James Stewart, Professor of Medicine, and KyungMann Kim, Professor of Biostatistics and Medical Informatics, each with > 20 years of clinical trials experience.

数据和安全监测系统。（DSMS）的UWCCC确保所有临床研究 在UWCCC的主持下进行符合联邦要求， 重要的是，人类受试者的安全总是最优化的。DSMS在其安全使命中得到协助， 由经验丰富的UWCCC研究人员、数据和安全监测委员会（DSMC） 由经验丰富的临床研究人员组成，并持续使用ONCORE数据库， 更有效地跟踪协议和协议主题。DSMC审查质量保证报告 （内部稽查、回复审查）、方案偏离和严重不良事件。DSMC还提供 数据审查、数据提取和输入、表格监测和为研究编制最终报告 由UWCCC单独监控DSMC由詹姆斯·斯图尔特（James Stewart）教授担任主席和联合主席。 医学，KyungMann Kim，生物统计学和医学信息学教授，各有20年以上的 临床试验经验。