Data Safety Monitoring Board (DSMB)

数据安全监控委员会 (DSMB)

• 批准号: 8084112
• 负责人: Matthew Carabasi
• 金额: $ 7.68万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-03 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8084112
• 关键词: Behavioral Research; Cancer Center; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Data; Ensure; Malignant Neoplasms; Modification; Monitor; Monitoring Clinical Trials; Office Management; Protocols documentation; Research Activity; Research Ethics Committees; Research Personnel; Review Committee; Safety; Social Welfare; Universities; anticancer research; authority; data integrity; falls; human subject; patient safety

DATA AND SAFETY MONITORING The Data and Safety Monitoring Plan (DSMP) of the Kimmel Cancer Center (KCC) provides for the oversight and monitoring of clinical trials to ensure the: 1. Safety of patients; and 2. Validity and integrity of the data collected on these trials. Responsibility for data and safety monitoring at Thomas Jefferson University resides in: 1. The Clinical Cancer Research Review Committee (CCRRC) which oversees the scientific review of all new and ongoing cancer-related clinical trials within the KCC; 2. The Clinical Research Management Office (CRMO) which provides strategic assistance and support to the CCRRC; 3. The IRB which has primary responsibility for the protection of the welfare of human subjects involved in biomedical and behavioral research. The IRB has full authority to approve, request modifications prior to approval, disapprove, suspend or terminate for cause all research activities that fall within its jurisdiction; and 4. The Data and Safety Monitoring Boards (DSMB), which are responsible for data and safety monitoring of Kimmel Cancer Center investigator initiated trials (KCC NT). The DSMP requires that every Kimmel Cancer Center protocol include a Data and Safety Monitoring plan. The CCRRC will not review a study that does not have such a plan, and the TJU IRB will not accept a study for review and approval until it has been approved by the CCRRC.

数据和安全监测 Kimmel癌症中心（KCC）的数据和安全性监测计划（DSMP）规定， 监督和监测临床试验，以确保： 1.患者的安全;以及 2.这些试验中收集的数据的有效性和完整性。 托马斯杰斐逊大学的数据和安全监测责任在于： 1.临床癌症研究审查委员会（CCRRC）负责监督以下方面的科学审查： KCC内所有新的和正在进行的癌症相关临床试验; 2.临床研究管理办公室（CRMO）提供战略援助和支持 CCRRC; 3. IRB主要负责保护相关人类受试者的福利 在生物医学和行为学研究中。IRB有全权批准、要求修改 在批准之前，不批准，暂停或终止其范围内的所有研究活动 管辖权;以及 4.数据和安全监测委员会（DSMB），负责数据和安全 Kimmel癌症中心研究者发起的试验（KCC NT）的监测。 DSMP要求Kimmel癌症中心的每个方案都包括数据和安全性监测计划。 CCRRC将不会审查没有此类计划的研究，TJU IRB将不会接受研究 审查和批准，直至获得CCRRC批准。