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中文摘要
翻译
临床研究办公室(CRO)提供中央管理和监督职能,以协调、 协助和报道L期癌症的临床试验、先导研究和人群研究 以机构试验为重点的中心。CRO服务包括:协议开发和 维护支持;监管支持;数据系统管理;质量控制;运营支持; 和信息系统。通过集中服务,CRO提供稳定而高效的行政管理 在梅奥诊所癌症中心(MCCC)的整个范围内协调这些活动。 这项服务适用于所有MCCC调查人员,无论是在梅奥校区。 CRO支持支持的临床试验和非干预性人群临床研究 通过以下一项或多项: ?同行审查的外部基金(国家卫生研究院、国防部等), 梅奥临床癌症中心(含CCSG) ?第一阶段和第二阶段(NCI,U01,N01) ?化学预防网络(CPN) NCI合作小组和CCOP计划[MCCC是中北部的研究基地 癌症治疗小组(NCCTG)是ACOSOG的统计和数据中心 并是ACOSOG、COG、ECOG、GOG、NCCTG和RTOG的成员] ?行业基金 能够对所有用户使用相同的远程登记系统、远程数据输入系统和数据库 研究并配置表格、接口和报告,以满足程序和协议的特定需求 所有赞助商和项目之间的体系和程序保持一致,并确保符合 监管要求。这种一致性促进了效率和方案运营协同,同时 利用不同NCI临床试验支持机制的专业知识。
英文摘要
The Clinical Research Office (CRO) provides central management and oversight functions for coordinating, facilitating and reporting on phase l-lll clinical trials, pilot studies and population-based studies of the Cancer Center with an emphasis on institutional trials. CRO services include: protocol development and maintenance support; regulatory support; data systems management; quality control; operational support; and information systems. With centralized services, the CRO provides a stable and efficient administrative structure to coordinate these activities across the entire scope of the Mayo Clinic Cancer Center (MCCC). This service is available to all MCCC investigators regardless of Mayo campus. 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 I and Phase II (NCI, U01, N01) ¿ Chemoprevention Network (CPN) ¿ NCI Cooperative Group and CCOP Programs [MCCC is the research base of the North Central Cancer Treatment Group (NCCTG), serves as the Statistics and Data Center for the ACOSOG and is a member of ACOSOG, COG, ECOG, GOG, NCCTG and RTOG] ¿ Industry funds The ability to use the same remote registration system, remote data entry system and database for all studies and to configure tables, interfaces and reports to meet program and protocol specific needs allows systems and procedures to be consistent between all sponsors and programs and ensures compliance with regulatory requirements. This consistency fosters efficiency and programmatic operational synergy while leveraging expertise across different NCI mechanisms of clinical trial support.
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NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1
  • 批准号:
    9914075
  • 项目类别:
  • 资助金额:
    $98.4万
  • 财政年份:
    2019
  • 负责人:
    STEVEN R ALBERTS
  • 依托单位:
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1
  • 批准号:
    10115645
  • 项目类别:
  • 资助金额:
    $108.41万
  • 财政年份:
    2019
  • 负责人:
    STEVEN R ALBERTS
  • 依托单位:
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1
  • 批准号:
    10582519
  • 项目类别:
  • 资助金额:
    $86.79万
  • 财政年份:
    2019
  • 负责人:
    STEVEN R ALBERTS
  • 依托单位:
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1
  • 批准号:
    10356075
  • 项目类别:
  • 资助金额:
    $93.1万
  • 财政年份:
    2019
  • 负责人:
    STEVEN R ALBERTS
  • 依托单位:
海外基金