Clinical Research Shared Services

临床研究共享服务

• 批准号: 8340249
• 负责人: KEVIN J. CULLEN
• 金额: $ 12.82万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-24 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8340249
• 关键词: Ally; Baltimore; Budgets; Cancer Center; Cancer Center Support Grant; Case Report Form; Chest; Cities; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Design; Community Outreach; Control Groups; Dana-Farber Cancer Institute; Data; Databases; Disease; Doctor of Medicine; Doctor of Philosophy; Funding; Genitourinary system; Grant; Growth; Hormone Responsive; Human Resources; Individual; Industry; Institutional Review Boards; Instruction; Life; Malignant Neoplasms; Maryland; Mediation; Medical; Medicine; Mission; Monitor; National Cancer Institute; Patients; Peer Review Grants; Personnel Management; Phase; Physician Executives; Physicians; Positioning Attribute; Preparation; Procedures; Process; Protocols documentation; Publications; Quality Control; Records; Reporting; Research; Research Personnel; Resources; Role; Safety; Services; South Carolina; Structure; System; Therapeutic; Time; Underrepresented Minority; Universities; Workload; anticancer research; cost; data management; leukemia; medical schools; member; organizational structure; professor; programs; protocol development; quality assurance; research and development

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.

临床研究共享服务(CRSS)与临床团队成员和研究人员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，包括与马里兰大学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 马里兰州马里兰州和斯图尔特格林鲍姆癌症中心(UMGCC)和UMGCC的数据安全监测/质量保证委员会。此外，CRSS还参与与赞助商的谈判，与马里兰大学巴尔的摩分校(UMB)的研究和发展办公室(UMB)一起制定临床试验预算。CRSS利用和管理OnCore数据库，为所有患者填写行业赞助研究的病例报告表，并将数据输入由国家癌症研究所和合作组赞助的试验I期或11期试验的适当数据库。OnCore还用于调查员发起的协议中的定制案例报告表格。 CRSS还收集信息，并将未得到充分服务的少数族裔临床试验应计利润的记录转发给巴尔的摩市癌症计划的医疗主任Shana Ntiri博士，以便于与CRC联合进行定期审查。Ntiri博士是临床研究社区外展的联络人。2010财年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美元来自其他同行审查的赠款支持。在最近的三年资助期内，CRSS资助了37种出版物，为UMGCC的激素反应性癌症和实验治疗计划提供服务。