Clinical Research Shared Service

临床研究共享服务

• 批准号: 7696610
• 负责人: EDWARD A. SAUSVILLE
• 金额: $ 15.19万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-08 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7696610
• 关键词: Accountability; Adverse event; Agreement; Annual Reports; Applications Grants; Baltimore; Basic Science; Budgets; Calendar; Cancer Center; Cancer Center Support Grant; Cancer and Leukemia Group B; Case Report Form; Categories; Charge; Clinical; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Trials; Collection; Consent; Consent Forms; Contractor; Contracts; Data; Databases; Development; Documentation; Dose; Drug usage; Educational Curriculum; Elements; Eligibility Determination; End Point; Evaluation; Funding; Grant; Guidelines; Gynecology; Hospital Departments; Hospitals; Housing; Human Resources; Image; Industry; Informed Consent; Infusion procedures; Ingestion; Investigational Drugs; Laboratories; Leadership; Maryland; Mediation; Medical; Medical Research; Modification; Monitor; Normal Range; Oncology Group; Patients; Peer Review Grants; Pharmaceutical Preparations; Pharmacology; Pharmacy facility; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Policies; Principal Investigator; Procedures; Process; Protocols documentation; Qualifying; Radiation; Radiation Therapy Oncology Group; Range; Records; Reporting; Research; Research Design; Research Ethics Committees; Research Personnel; Resources; Review Committee; Safety; Sampling; Schedule; Score; Serious Adverse Event; Services; Severe Adverse Event; Site Visit; Source; System; Therapy Clinical Trials; Time; Toxic effect; U-Series Cooperative Agreements; Underrepresented Minority; United States Food and Drug Administration; Universities; Work; demographics; design; dosimetry; handbook; medical schools; member; programs; quality assurance; research and development; research study; response; treatment planning

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.

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 支持临床方案的设计、开发和实施以及 审查委员会，包括马里兰大学医学院(UMSOM)的机构 审查委员会(IRB)，适用于马里兰大学所有项目的临床研究人员 和斯图尔特·格林鲍姆癌症中心(UMGCC)。临床研究监督委员会提供 关于CRSS分配的资源的指导。CRSS促进了UMGCC之间的互动 基础科学研究人员和临床研究人员。中国社会科学院支持研究人员发起科学研究 他们的方案的审查，这是由UMGCC的临床研究委员会(CRC)在 协议被提交给IRB。对于没有外部数据安全监控(DSM)进程的协议， CRSS还支持调查人员与UMGCC的DSM/质量保证进行互动 委员会(DSM/QAC)。 2008财政年度(2008财政年度)，综合社会保障计划的预计预算总额为2,475,926元：581,315元(23%) 来自UMGCC基金的机构支持；来自马里兰大学的764,213美元(31%) 医疗系统；以及1,130,398美元(46%)来自同行评议赠款和工业试验。 自上一次UMGCC的核心拨款申请以来，CRSS已进行了广泛的修订：安装 新的领导层；正式确定了审查UMGCC协议应计费用的过程；修改了DSM/QAC 与IRB的审查同步的过程；致力于跟踪和促进 少数群体参与临床试验的服务不足；并获得和实施OnCore数据库，以 跟踪与不良事件和临床试验有关的人口统计学和里程碑事件。 在2007财年，UMGCC的有效和累积方案组合包括146项治疗试验和 65项非治疗性试验。社区服务中心使用约29.33名相当于全职工作人员的服务，包括 1名管理人员、15名研究协调员、5名数据管理人员或数据助理以及8.33名监管支助人员。 在07财年，242名新患者参加了治疗试验；704名新患者增加到 作为正在进行的研究的一部分，对2000多名患者进行了非治疗性试验。