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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, 促进和报告癌症的I-III期临床试验、试点研究和基于人群的研究, 中心以机构试验为重点。CRO服务包括:方案制定和 维护支持;法规支持;数据系统管理;质量控制;操作支持; 和信息系统。通过集中服务,CRO提供稳定高效的行政管理 在马约诊所癌症中心(MCCC)的整个范围内协调这些活动。 这项服务是提供给所有MCCC调查员,无论马约校园。 CRO支持临床试验和受支持的非干预性基于人群的临床研究 通过以下一项或多项: 同行评审的校外基金(NIH,国防部等), 马约诊所癌症中心(包括CCSG) <$I期和II期(NCI、U 01、N 01) 化学预防网络(CPN) NCI合作组和CCOP计划[MCCC是北中部的研究基地 癌症治疗小组(NCCTG),作为ACOSOG的统计和数据中心 并且是ACOSOG、COG、ECOG、GOG、NCCTG和RTOG的成员] 产业基金 能够为所有人使用相同的远程登记系统、远程数据输入系统和数据库 研究和配置表格、界面和报告,以满足程序和方案的特定需求, 系统和程序在所有赞助商和项目之间保持一致,并确保遵守 监管要求这种一致性促进了效率和方案业务协同作用, 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