Data Safety Monitoring Board (DSMB)

数据和安全监控 金梅尔癌症中心(KCC)的数据和安全监测计划(DSMP)为 监督和监测临床试验，以确保： 1.病人的安全；及 2.在这些试验中收集的数据的有效性和完整性。 托马斯·杰斐逊大学对数据和安全监控的责任在于： 1.临床癌症研究评审委员会(CCRRC)负责监督对 KCC内所有新的和正在进行的与癌症相关的临床试验； 2.提供战略援助和支持的临床研究管理办公室(CRMO) 向CCRRC提交； 3.对保护所涉人类受试者的福利负有主要责任的IRB 在生物医学和行为研究方面。IRB拥有批准、请求修改的完全权力 在批准之前，不批准、暂停或因此终止所有属于其 司法管辖权；以及 4.负责数据和安全的数据和安全监控委员会(DSMB) 监测基梅尔癌症中心研究人员发起的试验(KCC NT)。 DSMP要求每个金梅尔癌症中心的协议都包括一个数据和安全监测计划。 CCRRC不会审查没有这样计划的研究，TJU IRB也不会接受研究 在CCRRC批准之前进行审查和批准。

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.