CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

核心——方案审查和监控系统

• 批准号: 7494664
• 负责人: SAMUEL JACOBS
• 金额: $ 16.74万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7494664
• 关键词: Accounting; Antineoplastic Protocols; Behavioral; Biometry; Cancer Center; Chairperson; Clinical; Clinical Research; Clinical Trials; Closure; Data; Databases; Doctor of Philosophy; Documentation; Ensure; Insurance; Leadership; Medicine; Monitor; Patient Care; Process; Protocols documentation; Public Health Schools; Registered nurse; Research Design; Research Ethics Committees; Resources; Review Committee; Safety; Services; System; Universities; University of Pittsburgh Cancer Institute; anticancer research; cancer epidemiology; cancer prevention; doxycycline polymethaphosphate sodium complex; implementation trial; research study

The Protocol Review Committee (PRC) of UPCI is responsible for reviewing all clinical cancer research studies conducted at the University of Pittsburgh and UPMC, prior to initiation of the study. The UPCI Data Safety and Monitoring Committee (DMSC) is responsible for the safety, validity of data, appropriate closure of trials, and monitoring of UPCI clinical research. In January 2002, the PRC expanded to three committees. Committees A and B, each meets once a month, in order to facilitate prompt review of cancer treatment protocols. Committee C is responsible for reviewing all behavioral and cancer epidemiology, cancer prevention and control, and complemcntary medicine protocols. The PRC evaluates each protocol,to ensure appropriate study design and scientific quality, availability of outside and/or institutional resources allocated, fiscal accounting of the utilization of resources, insurance billing and third party coverage issues. Following PRC review, documentation is recorded in the UPCI Clinical Trials Management Application (CTMA). This database also includes documentation of all appropriate regulatory approvals.

UPCI的方案审查委员会（PRC）负责审查在匹兹堡大学和UPMC进行的所有临床癌症研究，在研究开始之前。UPCI数据安全和监测委员会（DMSC）负责数据的安全性、有效性、试验的适当结束以及UPCI临床研究的监测。