CORE--CLINICAL INVESTIGATIONS SUPPORT FACILITY
CORE--CLINICAL INVESTIGATIONS SUPPORT FACILITY
批准号:
6443826
负责人:
DARCY V SPICER
金额:
$9.16万
依托单位国家:
美国
项目类别:
财政年份:
1980
资助国家:
美国
项目状态:
已结题
起止时间:
1980-04-01 至 2005-11-30
中文摘要
临床研究支持办公室(CISO)的成立是为了向南加州大学/诺里斯综合癌症中心的研究人员提供服务、技术和科学咨询,以提高科学生产率并促进跨学科互动和研究。CISO是一个由个人组成的集中式组织,在临床试验开发和管理方面具有特定和专门的角色。CISO为方案制定、审查、优先顺序、法规遵从性、研究进行和监控以及质量保证提供集中管理。这一共享资源有两个组成部分:一个集中的协议管理单元和一个研究护理/数据管理单元。临床研究活动的集中管理对于癌症中心有效地进行临床试验至关重要。CISO方案和数据管理系统为开展外部资助和内部同行评审和监测的研究临床试验提供必要的集中支持服务。CISO与临床调查委员会和质量保证委员会的运作紧密结合。CISO维护所有协议和法规文件,分发协议,提供集中的数据质量控制和监督,以及维护协议数据库。研究护理/数据管理股提供集中的职能,在患者资格评估、数据质量控制和监督方面向调查人员提供咨询和协助。CISO拥有一套办公室,位于Topping Tower的7层,卫星空间位于洛杉矶县+南加州大学医疗中心患者治疗区附近。
英文摘要
The Clinical Investigations Support Office (CISO) was established to provide investigators at the USC/Norris Comprehensive Cancer Center services, technologies and scientific consultation to enhance scientific productivity and foster interdisciplinary interaction and research. CISO is a centralized organization of individuals with specific and specialized roles in clinical trials development and administration. CISO provides a centralized administration for protocol development, review, prioritization, regulatory compliance, study conduct and monitoring and quality assurance. This shared resource has two components: a centralized Protocol Administration Unit and a Research Nursing/Data Management Unit. The centralized administration of clinical research activities is critical to the efficient conduct of clinical trials at the Cancer Center. The CISO protocol and data management system provides the centralized support services necessary for the conduct of externally- funded and internally peer-reviewed and monitored research clinical trials. CISO is tightly integrated with the operations of the Clinical Investigations Committee and the Quality Assurance Committee. CISO maintains all protocols and regulatory documents, distributes protocols, provides centralized data quality control and oversight, and maintenance of protocols databases. The Research Nursing/Data Management Unit provides the centralized function of advising and assisting investigators in patient eligibility assessments, data quality control and oversight. CISO occupies a suite of offices located on the 7th floor o the Topping Tower and satellite space located in proximity to patient treatment areas at the Los Angeles County+USC Medical Center.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
SCCISARS 2: An e-Solution to Protect Human Subjects
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批准号:6777898
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项目类别:
-
资助金额:$35.0万
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财政年份:2002
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负责人:DARCY V SPICER
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依托单位:
A PHASE I STUDY OF THE GARFT INHIBITOR AG2034 IN PATIENTS WITH ADVANCED CANCER
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批准号:6421242
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项目类别:
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资助金额:$15.58万
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财政年份:2000
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负责人:DARCY V SPICER
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依托单位:
PHASE II RANDOMIZED STUDY OF PACLITAXEL VS PACLITAXEL+PSC833 FOR BREAST CANCER
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批准号:6421187
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项目类别:
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资助金额:$15.58万
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财政年份:2000
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负责人:DARCY V SPICER
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依托单位:
PHASE II RANDOMIZED STUDY OF PACLITAXEL VS PACLITAXEL+PSC833 FOR BREAST CANCER
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批准号:6303709
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项目类别:
-
资助金额:$3.56万
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财政年份:1999
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负责人:DARCY V SPICER
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依托单位:
A PHASE I STUDY OF THE GARFT INHIBITOR AG2034 IN PATIENTS WITH ADVANCED CANCER
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批准号:6113677
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项目类别:
-
资助金额:$3.56万
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财政年份:1998
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负责人:DARCY V SPICER
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依托单位:
GNRH AGONIST REGIMEN FOR BREAST CANCER PREVENTION
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批准号:2718898
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项目类别:
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资助金额:$19.63万
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财政年份:1998
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负责人:DARCY V SPICER
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依托单位:
PHASE II RANDOMIZED STUDY OF PACLITAXEL VS PACLITAXEL+PSC833 FOR BREAST CANCER
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批准号:6113629
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项目类别:
-
资助金额:$3.56万
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财政年份:1998
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负责人:DARCY V SPICER
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依托单位:
A PHASE I STUDY OF THE GARFT INHIBITOR AG2034 IN PATIENTS WITH ADVANCED CANCER
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批准号:6274911
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项目类别:
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资助金额:$3.67万
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财政年份:1997
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负责人:DARCY V SPICER
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依托单位:
PHASE II RANDOMIZED STUDY OF PACLITAXEL VS PACLITAXEL+PSC833 FOR BREAST CANCER
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批准号:6274863
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项目类别:
-
资助金额:$3.67万
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财政年份:1997
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负责人:DARCY V SPICER
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依托单位:
A PHASE I STUDY OF THE GARFT INHIBITOR AG2034 IN PATIENTS WITH ADVANCED CANCER
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批准号:6303764
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项目类别:
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资助金额:$3.56万
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财政年份:--
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负责人:DARCY V SPICER
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依托单位:
A PHASE I STUDY OF THE GARFT INHIBITOR AG2034 IN PATIENTS WITH ADVANCED CANCER
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批准号:6353695
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项目类别:
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资助金额:$15.58万
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财政年份:--
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负责人:DARCY V SPICER
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依托单位:
海外基金