Clinical Research Shared Service

临床研究共享服务 临床研究共享服务（CRSS）是人员、资源和流程的中心集合 支持临床协议的设计、开发和实施以及 审查委员会，包括马里兰州医学院（UMSOM）的机构 审查委员会（IRB），适用于在马里兰州马琳大学所有项目中工作的临床研究者 Stewart Greenebaum癌症中心（UMCCC）临床研究监督委员会提供 对CRSS分配的资源的指导。CRSS促进UMCCC之间的交互 基础科学研究者和临床研究者。CRSS支持研究者发起科学研究， 审查他们的方案，这是由UMCCC的临床研究委员会（CRC）在 将方案提交给IRB。对于没有外部数据安全监测（DSM）过程的方案， CRSS还支持调查人员与UMCCC的DSM/质量保证部门进行互动 委员会（DSM/QAC）。 对于2008财政年度（FY 08），CRSS的预计总预算为2，475，926美元：581，315美元（23%） 来自UMCCC基金的机构支持;来自马里兰州大学的764，213美元（31%） 医疗系统;和1,130,398美元（46%）来自同行评审的赠款和工业试验。 CRSS自UMCCC最后一次核心赠款申请以来进行了广泛修订：安装 新的领导层;正式制定了审查UMCCC协议应计费用的流程;修改了DSM/QAC 与IRB审查同步的流程;致力于跟踪和促进 少数人参与临床试验;并获得和实施Oncore数据库， 跟踪与不良事件和临床试验相关的人口统计学和里程碑。 2007财年，UMCCC的积极和累积方案组合包括146项治疗试验， 65个非治疗性试验。CRSS使用大约29.33全职同等人员的服务，包括 1名经理，15名研究协调员，5名数据经理或数据助理，以及8.33名监管支持人员。 在2007财年，242名新患者参加了治疗试验; 704名新患者参加了 非治疗性试验;作为正在进行的研究的一部分，对2,000多名患者进行了随访。

Clinical Research Shared Service The Clinical Research Shared Service (CRSS) is the central set of personnel, resources, and processes that supports the design, development, and implementation of clinical protocols and interactions among review committees, including the University of Maryland School of Medicine's (UMSOM's) Institutional Review Board (IRB), for clinical investigators working in all programs at the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). The Clinical Research Oversight Committee provides guidance on resources that are apportioned by CRSS. CRSS facilitates interactions between UMGCC's basic science investigators and clinical investigators. CRSS supports investigators in initiating the scientific review of their protocols, which is performed by UMGCC's Clinical Research Committee (CRC) before the protocol is submitted to the IRB. For protocols without an external Data Safety Monitoring (DSM) process, the CRSS also supports investigators in their interactions with UMGCC's DSM/Quality Assurance Committee (DSM/QAC). For Fiscal Year 2008 (FY08), the total projected budget for CRSS is $2,475,926: $581,315 (23 percent) from institutional support through UMGCC's funds; $764,213 (31 percent) from the University of Maryland Medical System; and $1,130,398 (46 percent) from peer-reviewed grants and industrial trials. The CRSS has been revised extensively since the last core grant application from UMGCC: installed new leadership; formalized a process for reviewing accrual to UMGCC protocols; revamped the DSM/QAC process that has been synchronized with reviews of the IRB; dedicated an effort to track and promote underserved minority participation in clinical trials; and acquired and implemented the Oncore¿ database to track demographics and milestones pertaining to adverse events and clinical trials. For FY07, UMGCC's portfolio of active and accruing protocols included 146 therapeutic trials and 65 nontherapeutic trials. CRSS uses the services of approximately 29.33 full-time equivalents, including 1 manager, 15 research coordinators, 5 data managers or data assistants, and 8.33 regulatory support staff. During FY07, 242 new patients were accrued to therapeutic trials; 704 new patients were accrued to nontherapeutic trials; and more than 2,000 patients were being followed as part of ongoing research studies.