Administrative Core

核心A将为计划项目的所有方面提供科学、预算、行政、后勤和生物统计方面的监督。中心将促进调查人员之间的交流和试剂、工具、标本和数据的共享；将确保为每个项目适当分配资金并适当使用这些资金；将提供文书支助；将与转包机构协调项目；将定期组织调查人员会议；并将提供生物统计援助。核心领导博利博士将负责方案项目的总体协调、整合和管理，适当使用资金，遵守机构和联邦法规，科学 本计划的生产力以及与本计划相关的任何问题。首席调查员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。首席调查员和执行委员会将于 每月讨论四个项目的科学进展、数据、问题和未来方向。 科学责任包括(1)在保持研究人员的关注方面提供领导，(2)提供统计援助，以及(3)所有计划项目调查人员每周开会。行政和财务责任包括(1)执行计划项目支持指南，(2)根据NIH指南管理预算，(3)监督每个项目和核心的预算，以及(4)确保遵守机构和NIH规定。在核心工作的生物统计师将是孔麦英博士。她将出席执行委员会的月度会议，审查 实验数据，分析它们，并计算群体大小，以供未来研究。她将把他/她10%的时间投入到这个项目中。这项计划的一个重要方面是，在孔博士公布最终数据分析之前，对CPC进行活体研究的研究人员将对治疗视而不见。另一个重要方面是，所有样本量将在实验开始前选择(基于孔博士的功率分析)，并且不会改变；实验将一直进行，直到达到预定的样本量，而不知道中期结果。在达到预定的样本量后，所有数据将被提供给孔博士，在那里他们将被解盲并用适当的统计方法进行分析。每个项目将利用核心A的25%。

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.