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CORE--CLINICAL RESEARCH OFFICE

CORE--CLINICAL RESEARCH OFFICE
核心--临床研究室
批准号:
6990026
负责人:
JAN C BUCKNER
金额:
$35.85万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2004
资助国家:
美国
项目状态:
已结题
起止时间:
2004-09-15 至 2009-02-28

项目摘要

项目成果

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中文摘要
翻译
临床研究办公室(CRO)的目的是提供中央管理和监督职能,以协调、促进和报告中心的癌症临床研究,无论其来源如何。CRO通过向马约诊所癌症中心(MCCC)研究者提供以下服务来实现这一目的:1)方案开发和维护支持,2)法规支持,3)数据系统管理,4)质量控制,5)运营支持和6)信息系统。 通过集中服务,CRO提供了一个稳定而高效的行政结构,以协调MCCC整个范围内的这些活动,包括I-III期临床试验、中试研究和基于人群的研究。 临床研究办公室以前是马约诊所癌症中心统计部门共享资源的一部分。这一共享资源由两个股组成-统计股和研究支助服务股。由于最近范围的显著扩大和监管负担的增加,这两个单位现已分离,形成生物统计共享资源和临床研究办公室。 CRO支持由以下一项或多项支持的临床试验和非干预性基于人群的临床研究: ?同行评审的校外基金(NIH,DoD等), ?马约诊所癌症中心(包括CCSG) ?二期土地(NCI、U 01、N 01) ? NCI合作组和CCOP计划(MCCC是北中部的研究基地 癌症治疗组(NCCTG)和ECOG、RTOG、GOG、ACoSOG和COG成员) ?产业基金 所有研究使用相同数据库以及配置表格、界面和报告以满足项目或方案特定需求的能力,允许所有申办者和项目之间的系统和程序保持一致。这种一致性促进了效率和方案业务的协同作用。
英文摘要
The purpose of the Clinical Research Office (CRO) is to provide central management and oversight functions for coordinating, facilitating, and reporting on the cancer clinical research of the center, whatever the origin. The CRO accomplishes this purpose by providing the following services to Mayo Clinic Cancer Center (MCCC) investigators: 1) Protocol development and maintenance support, 2) Regulatory support, 3) Data systems management, 4) Quality control, 5) Operational support, and 6) Information systems. With centralized services, the CRO provides a stable and efficient administrative structure to coordinate these activities across the entire scope of the MCCC, including phase I-III clinical trials, pilot studies, and population-based studies. The Clinical Research Office previously functioned as part of the Mayo Clinic Cancer Center Statistics Unit Shared Resource. This shared resource was comprised of two units - the Statistics Unit and the Research Support Services Unit. Due to the recent significant expansion in scope and increase in regulatory burden, the two units have now separated, forming the Biostatistics Shared Resource and the Clinical Research Office. The CRO supports clinical trials and non-interventional population-based clinical research that are supported by one or more of the following: ? Peer-reviewed extramural funds (NIH, DoD, etc.), ? Mayo Clinic Cancer Center (including CCSG) ? Phase land Phase II (NCI, U01, N01) ? NCI Cooperative Group and CCOP Programs (MCCC is the research base of the North Central Cancer Treatment Group (NCCTG) and a member of ECOG, RTOG, GOG, ACoSOG, and COG) ? Industry funds The ability to use the same database for all studies and to configure tables, interfaces, and reports to meet program or protocol specific needs, allows the systems and procedures to be consistent between all sponsors and programs. This consistency fosters efficiency and programmatic operational synergy.
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Alliance NCORP Research Base
  • 批准号:
    8790220
  • 项目类别:
  • 资助金额:
    $963.03万
  • 财政年份:
    2014
  • 负责人:
    JAN C BUCKNER
  • 依托单位:
Collaborations and NCORP Collective Management
  • 批准号:
    10915754
  • 项目类别:
  • 资助金额:
    $40.66万
  • 财政年份:
    2014
  • 负责人:
    JAN C BUCKNER
  • 依托单位:
North Central Cancer Treatment Group
  • 批准号:
    7933204
  • 项目类别:
  • 资助金额:
    $22.5万
  • 财政年份:
    2009
  • 负责人:
    JAN C BUCKNER
  • 依托单位:
NCCTG Biospecimen Resource
  • 批准号:
    7616774
  • 项目类别:
  • 资助金额:
    $89.24万
  • 财政年份:
    2005
  • 负责人:
    JAN C BUCKNER
  • 依托单位:
海外基金