Clinical Research Shared Service

临床研究共享服务

基本信息

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
项目类别：
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

项目摘要

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）是一组人员，资源和流程支持临床方案的设计，开发和实施审查委员会，包括马里兰大学医学院（UMSOM）机构审查委员会（IRB），用于马里兰州大学所有课程工作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 CRS任命的资源指南。 CRSS收藏夹umgcc之间的互动基础科学研究者和临床研究人员。 CRSS支持调查人员启动科学审查其协议，该协议由UMGCC的临床研究委员会（CRC）执行协议已提交给IRB。对于没有外部数据安全监控（DSM）过程的协议， CRS还支持调查人员与UMGCC的DSM/质量保证进行互动委员会（DSM/QAC）。对于2008财年（08财年），CRS的预计总预算为$ 2,475,926：581,315美元（23％）从机构支持到UMGCC的资金；马里兰大学的$ 764,213（31％）医疗系统；以及同行评审的赠款和工业试验的1,130,398美元（46％）。自UMGCC上一次核心赠款应用程序以来，CRSS已进行了广泛的修订：已安装新领导；正式对审查UMGCC协议准确性的过程进行了形式化；修改了DSM/QAC 与IRB的评论同步的过程；致力于追踪和促进服务不足的少数群体参与临床试验；并获取并实施了oncore¿数据库跟踪与不良事件和临床试验有关的人口统计学和里程碑。对于07财年，UMGCC的主动和应计方案组合包括146次治疗试验和 65个非治疗试验。 CRSS使用大约29.33个全职等效的服务，包括 1名经理，15位研究协调员，5位数据经理或数据助手和8.33个监管支持人员。在07财年期间，将242名新患者获得治疗试验。 704名新患者被接受非治疗试验；作为正在进行的研究的一部分，有2,000多名患者被遵循。