Clinical Research Shared Services

临床研究共享服务（CRSS）与临床团队成员和研究者一起参与临床试验设计、审查、实施和质量保证监测准备的所有细节，包括与马里兰州医学院机构审查委员会、马里兰大学临床研究委员会（CRC）（或方案审查和监测系统）的互动。 马里兰州Marlene和Stewart Greenebaum癌症中心（UMCCC），以及UMCCC的数据安全监测/质量保证委员会。此外，CRSS还与马里兰大学巴尔的摩分校（UMB）的研发办公室一起参与与申办者的谈判，以制定临床试验预算。CRSS利用并管理所有患者的Oncore <$数据库，完成行业申办研究的病例报告表，并将数据输入由国家癌症研究所申办的I期或11期试验和合作组申办试验的适当数据库。Oncore还用于在制药商发起的方案中定制病例报告表。 CRSS还收集信息，并将服务不足的少数族裔应计临床试验的记录转发给巴尔的摩市癌症项目的医学主任Shana Ntiri博士，以便于与CRC一起进行定期审查。Ntiri博士担任临床研究社区外展的联络员。在2010财政年度，CRSS费用为3，325，306美元，其中280，124美元来自癌症中心支持补助金 358，876美元来自其他同行评审的赠款支持。在最近的3年资助期内，CRSS支持了37篇出版物，为UMCCC的激素反应性癌症和实验治疗项目提供服务。

The Clinical Research Shared Service (CRSS) participates with members of clinical teams and investigators on all details of clinical trial design, review, implementation, and preparation for quality assurance monitoring, including interactions with the Institutional Review Board of the University of Maryland School of Medicine, the Clinical Research Committee (CRC) (or Protocol Review and Monitoring System) of the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC), and the Data Safety Monitoring/Quality Assurance Committee of UMGCC. In addition, CRSS participates in negotiating with sponsors to develop budgets for clinical trials in conjunction with the Office of Research and Development at the University of Maryland-Baltimore (UMB). CRSS utilizes and manages the Oncore¿ database for all patients¿completing case report forms for industry-sponsored studies and entering data into appropriate databases for Phase I or Phase 11 trials sponsored by the National Cancer Institute and cooperative group sponsored trials. Oncore¿ is also utilized for customized case report forms in investigator-initiated protocols. CRSS also collects information and forwards records of underserved minority accrual to clinical trials to Dr. Shana Ntiri, medical director of the Baltimore City Cancer Program, to facilitate periodic reviews in conjunction with CRC. Dr. Ntiri serves as the liaison for clinical research community outreach. During fiscal year 2010 CRSS costs were $3,325,306, of which $280,124 were from the Cancer Center Support Grant and $358,876 were from other peer-reviewed grant support. During the latest 3-year grant period, 37 publications were supported by CRSS, serving the Hormone Responsive Cancers and Experimental Therapeutics Programs at UMGCC.