Data and Safety Monitoring

项目总结（见说明）： 数据安全监测/质量保证委员会（DSM/QAC）确保马里兰州大学Marlene和Stewart Greenebaum癌症中心（UMCCC）临床研究受试者的患者安全。UMCCC的DSM/QAC持续审查内部和外部严重不良事件（SAE），以确定是否向机构审查委员会（IRB）快速报告 马里兰州大学医学院（UMSOM）和/或变更知情同意书。 UMCCC的DSM/QAC被IRB认可为UMCCC方案的DSM记录主体，该方案没有独立的DSM过程。DSM/QAC以这种身份审查以下类型的方案：任何阶段的制药商发起的试验，所有I期试验（无论申办者如何），以及独立DSM委员会不活跃的NCI申办或公司II期试验。上 至少每年一次，这需要审查知情同意书的通用性和准确性、方案监管文件夹、应答率、稽查结果，以及审查期间的累积是否在最新IRB审查的允许入组范围内。DSM/QAC将审查与UMSOM的IRB签订合同并由UMSOM的IRB执行的稽查，其中50%的患者属于其权限范围内的方案类型。 必要时，DSM/QAC还可指导其对DSM/QAC权限范围内试验的稽查。DSM/QAC审查的时间安排在年度IRB审查之前。最后，在履行其机构任务，提供早期临床试验的实时管理，DSM/QAC还将评估I期研究的剂量限制性毒性，在每个队列之后，剂量递增之前，每半年一次。需求管理/质保局会议 每月一次，需要三名成员的法定人数。在2009日历年，在DSM/QAC会议上采取了129项行动。其中，93项为方案年度审查，9项为安全性审查，13项为主要研究者对DSM/QAC先前质询的回复审查，12项为内部安全性审查或IRB进行的稽查审查，结果有两项方案暂停（计为不同的行动）。在93项年度审查中，78项被批准继续进行; 12项仍然开放，但规定了纠正措施; 3项被提交临床研究委员会考虑关闭，所有应计费用都很差。

PROJECT SUMMARY (See Instructions): The Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) ensures the safety of patients who are subjects in clinical research at the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). UMGCC's DSM/QAC reviews in an ongoing fashion Severe Adverse Events (SAEs), internal and external, to define whether expedited reporting to the Institutional Review Board (IRB) ofthe University of Maryland School of Medicine (UMSOM) and/or altering informed consent is warranted. UMGCC's DSM/QAC is recognized by IRB as the DSM body of record for UMGCC protocols that do not have a freestanding, independent DSM process. DSM/QAC reviews in that capacity the following types of protocols: investigator-initiated trials of any phase, all Phase I trials irrespective of sponsor, and NCI-sponsored or corporate Phase II trials for which an independent DSM committee is not active. On at least an annual basis, this entails reviewing the currency and accuracy of the consent form, the protocol regulatory binder, response rates, audit results, and whether accrual during the review period is within the allowed enrollment according to the latest IRB review. DSM/QAC will review audits contracted to and performed by UMSOM's IRB of 50 percent of patients accrued to the protocol types under its purview. DSM/QAC may also direct its own audits, as necessary, of trials under DSM/QAC purview. The timing of the DSM/QAC review is prior to the annual IRB review. Finally, in pursuing its institutional mandate to provide real-time governance of the conduct of early-phase clinical trials, DSM/QAC will also assess Phase I studies for dose-limiting toxicities after each cohort, before dose escalation, and semiannually. DSM/QAC meets monthly and requires a quorum of three members. For calendar year 2009, 129 actions occurred at DSM/QAC meetings. Of these, 93 were annual reviews of protocols, 9 were safety reviews, 13 were reviews of responses from principal investigators to previous queries from DSM/QAC, and 12 were reviews of internal safety reviews or IRB conducted audits, with two protocols suspended as a result (counted as distinct actions). Of the 93 annual reviews, 78 were approved for continuance; 12 remained open but had corrective actions prescribed; and 3 were referred for consideration of closure by the Clinical Research Committee, all with poor accruals.