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中文摘要
翻译
核心A将为计划项目的各个方面提供科学、预算、行政、后勤和生物统计监督。核心委员会将促进研究者之间的沟通,共享试剂、工具、标本和数据;确保每个项目的资金分配和资金使用得当;提供文书支持;与分包机构协调项目;定期组织研究者会议;提供生物统计协助。Bolli博士,核心负责人,将负责该计划项目的整体协调、整合和管理,适当利用资金,遵守机构和联邦法规, 该计划的生产力,以及与该计划有关的任何问题。主要研究者将得到执行委员会其他成员的协助,执行委员会将由四名项目负责人和四名核心负责人组成。主要研究者和执行委员会将在 每月讨论四个项目的科学进展、数据、问题和未来方向。 科学职责包括(1)领导研究者保持关注重点,(2)提供统计协助,以及(3)每周召开一次所有项目研究者会议。行政和财务职责包括:(1)实施计划项目支持指南,(2)根据NIH指南管理预算,(3)监控每个项目和核心的预算,以及(4)确保遵守机构和NIH法规。在中心工作的生物统计学家将是Dr. Maiying Kong。她将出席执行委员会的月度会议,审查 实验数据,分析它们,并为未来的研究计算组的大小。她将把10%的时间用于这个项目。该项目的一个重要方面是,在Dr. Kong发布最终数据分析之前,对CPC进行体内研究的研究者将对治疗保持盲态。另一个重要的方面是,所有样本量将在实验开始前选择(基于Kong博士的把握度分析),并且不会改变;实验将在达到预定样本量之前进行,而不知道中期结果。达到预定样本量后,将所有数据交给Dr. Kong,在那里将揭盲并通过适当的统计方法进行分析。每个项目将使用核心A的25%。
英文摘要
Core A will provide scientific, budgetary, administrative, logistic, and biostatistical oversight to all aspects of the Program Project. The Core will facilitate communication among investigators and sharing of reagents, tools, specimens, and data; will ensure appropriate allocation of funds to each Project and appropriate use of these funds; will provide clerical support; will coordinate the Projects with subcontracted institutions; will organize regular investigator meetings; and will provide biostatistical assistance. Dr. Bolli, Core Leader, will be responsible for the overall coordination, integration, and administration of the Program Project, for the appropriate utilization of the funds, for compliance with institutional and federal regulations, for the scientific productivity of the Program, and for any issues related to the Program. The Principal Investigator will be assisted by the other members of the Executive Committee, which will be composed of the four Project Leaders and the four Core Leaders. The Principal Investigator and the executive Committee will meet on a monthly basis to discuss the scientific progress, data, problems, and future directions for the four Projects. Scientific responsibilities include (1) providing leadership in maintaining the focus of the investigators, (2) providing statistical assistance, and (3) weekly meetings of all Program Project Investigators. Administrative and financial responsibilities include (1) implementing guidelines for Program Project support, (2) administering the budget according to NIH guidelines, (3) monitoring budgets for each Project and Core, and (4) ensuring compliance with the institutional and NIH regulations. The Biostatistician working in the Core will be Dr. Maiying Kong. She will attend the monthly meetings of the Executive Committee, review the experimental data, analyze them, and calculate group sizes for future studies. She will devote 10% of his/her time to this Program Project. An important aspect of this Program Project is that the investigators performing in vivo studies of CPCs will be blinded to the treatment until the final data analysis is released by Dr. Kong. Another important aspect is that all sample sizes will be selected before the experiments are started (based upon power analysis by Dr. Kong) and will not be changed; the experiments will be carried out until the predetermined sample sizes are achieved, without any knowledge of interim results. After the predetermined sample sizes are achieved, all data will be given to Dr. Kong, where they will be unblinded and analyzed by appropriate statistical methods. Each Project will utilize 25% of Core A.
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University of Louisville Regional Clinical Center for the CCTRN
  • 批准号:
    8448108
  • 项目类别:
  • 资助金额:
    $44.55万
  • 财政年份:
    2012
  • 负责人:
    Roberto Bolli
  • 依托单位:
University of Louisville Regional Clinical Center for the CCTRN
  • 批准号:
    8288932
  • 项目类别:
  • 资助金额:
    $48.1万
  • 财政年份:
    2012
  • 负责人:
    Roberto Bolli
  • 依托单位:
University of Louisville Regional Clinical Center for the CCTRN
  • 批准号:
    9437819
  • 项目类别:
  • 资助金额:
    $46.8万
  • 财政年份:
    2012
  • 负责人:
    Roberto Bolli
  • 依托单位:
University of Louisville Regional Clinical Center for the CCTRN
  • 批准号:
    9230424
  • 项目类别:
  • 资助金额:
    $46.8万
  • 财政年份:
    2012
  • 负责人:
    Roberto Bolli
  • 依托单位:
海外基金