CORE--PROTOCOL REVIEW AND MONITORING SYSTEM
CORE--PROTOCOL REVIEW AND MONITORING SYSTEM
批准号:
7111832
负责人:
SAMUEL JACOBS
金额:
$6.2万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
中文摘要
UPCI的方案审查委员会(PRC)负责在研究开始前审查在匹兹堡大学和UPMC进行的所有临床癌症研究。UPCI数据安全和监测委员会(DMSC)负责数据的安全性、有效性、试验的适当关闭以及UPCI临床研究的监测。
2002年1月,委员会扩大为三个委员会。A委员会和B委员会每月各举行一次会议,以促进迅速审查癌症治疗方案。C委员会负责审查所有行为和癌症流行病学、癌症预防和控制以及补充医学方案。PRC对每个方案进行评估,以确保适当的研究设计和科学质量、外部和/或分配的机构资源的可用性、资源利用的财务会计、保险账单和第三方覆盖问题。
PRC审查后,将文件记录在UPCI临床试验管理应用程序(CTMA)中。该数据库还包括所有适当的监管批准文件。
英文摘要
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.
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会议论文
CLINICAL RESEARCH SERVICES CLINICAL TRIALS OFFICE
-
批准号:6989585
-
项目类别:
-
资助金额:$19.46万
-
财政年份:2004
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--PROTOCOL REVIEW AND MONITORING SYSTEM
-
批准号:6989599
-
项目类别:
-
资助金额:$6.02万
-
财政年份:2004
-
负责人:SAMUEL JACOBS
-
依托单位:
Cancer Center Model For Early Phase Clinical Trials
-
批准号:6666180
-
项目类别:
-
资助金额:$63.88万
-
财政年份:2003
-
负责人:SAMUEL JACOBS
-
依托单位:
Cancer Center Model For Early Phase Clinical Trials
-
批准号:6794174
-
项目类别:
-
资助金额:$64.66万
-
财政年份:2003
-
负责人:SAMUEL JACOBS
-
依托单位:
Cancer Center Model For Early Phase Clinical Trials
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批准号:7124526
-
项目类别:
-
资助金额:$2.1万
-
财政年份:2003
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--CLINICAL RESEARCH SERVICES CLINICAL TRIALS OFFICE
-
批准号:7494660
-
项目类别:
-
资助金额:$54.09万
-
财政年份:--
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--PROTOCOL REVIEW AND MONITORING SYSTEM
-
批准号:7279248
-
项目类别:
-
资助金额:$6.39万
-
财政年份:--
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--PROTOCOL REVIEW AND MONITORING SYSTEM
-
批准号:7494664
-
项目类别:
-
资助金额:$16.74万
-
财政年份:--
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--CLINICAL RESEARCH SERVICES CLINICAL TRIALS OFFICE
-
批准号:7111828
-
项目类别:
-
资助金额:$20.04万
-
财政年份:--
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--CLINICAL RESEARCH SERVICES CLINICAL TRIALS OFFICE
-
批准号:7279244
-
项目类别:
-
资助金额:$20.64万
-
财政年份:--
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--PROTOCOL REVIEW AND MONITORING SYSTEM
-
批准号:7669409
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项目类别:
-
资助金额:$15.53万
-
财政年份:--
-
负责人:SAMUEL JACOBS
-
依托单位:
CORE--CLINICAL RESEARCH SERVICES CLINICAL TRIALS OFFICE
-
批准号:7669405
-
项目类别:
-
资助金额:$50.19万
-
财政年份:--
-
负责人:SAMUEL JACOBS
-
依托单位:
海外基金