Operations and Clinical Assessment Core
Operations and Clinical Assessment Core
批准号:
8099708
负责人:
STEPHEN M STRAKOWSKI
金额:
$63.11万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2010
资助国家:
美国
项目状态:
已结题
起止时间:
2010-07-01 至 2012-06-30
关键词:
Administrative PersonnelAdvisory CommitteesBiometryClinicalClinical assessmentsData Base ManagementEnsureEvaluationGoalsInformed ConsentMeasurementNIH Program AnnouncementsPatient RecruitmentsPreparationProtocols documentationReportingResearch DesignResourcesRoleSample SizeStatistical Data InterpretationTranslationsdata managementhuman subjectmeetingsoperation
中文摘要
操作和临床评估核心(OCAC)满足CIDAR中描述的所需核心
节目公告(PA05-039)。OCAC将发挥三大职能:1)总体中心
行政;2)科目征聘和评估;3)数据库管理和统计
分析。因此,OCAC被划分为与这些专业相对应的三个部门
功能。每个部门都有一名主管专门负责确保该部门的目标和目的
部门会议;这些董事向斯特拉科夫斯基博士报告,斯特拉科夫斯基博士将担任OCAC主任,除了他的
作为BITREC的总体总监。行政司将对BITREC进行全面管理;
为了实现这一目标,它将由BITREC主任、一个指导委员会、两个外部咨询机构组成
委员会和行政人员。斯特拉科夫斯基博士将领导这个部门,与他的角色一致
OCAC和BITREC主管。OCAC的临床评估和招聘部(CARD)将
提供患者招募、知情同意和人体受试者监管职能,以及初步
评估。我们选择将这些职能集中在一起,以便整合项目和维护
各项目的主题管理和评估保持一致。德尔贝洛博士将指导这张卡。这个
按照CIDAR计划公告的要求,生物统计司(BD)包括在OCAC中,
尽管,鉴于生物统计学在这个中心中的核心作用,该司在许多方面将发挥作用
核心。生物统计司将是所有项目和核心使用的中心资源。这个部门将
提供将临床假说转换为可检验的统计假说的专业知识,选择
有效的研究设计和测量方案、样本量需求的估计、采集和
数据管理、统计分析和最终报告的准备。生物统计司将联合指导
萨科普博士和阿恩特博士写的。OCAC的各司将提供组织和整合
在所有剩余的核心和项目中发挥作用。
英文摘要
The Operations and Clinical Assessment Core (OCAC) fulfills the required core described in the CIDAR
Program Announcement (PA05-039). The OCAC will serve three major functions: 1) overall center
administration; 2) subject recruitment and assessment; and 3) database management and statistical
analysis. Consequently, the OCAC has been divided into three divisions corresponding with these major
functions. Each division has a director specifically assigned to ensure that the goals and objectives for that
division are met; these directors report to Dr. Strakowski, who will serve as OCAC director, in addition to his
role as overall BITREC director. The Administrative Division will provide overall management of the BITREC;
to achieve this goal it will be composed of the BITREC director, a Steering Committee, two external advisory
committees and administrative personnel. Dr. Strakowski will direct this division, consistent with his roles as
OCAC and BITREC director. The Clinical Assessment and Recruitment Division (CARD) of the OCAC will
provide patient recruitment, informed consent and human subjects regulatory functions, and initial
assessments. We have chosen to centralize these functions in order to integrate projects and to maintain
consistent subject management and evaluations across projects. Dr. DelBello will direct the CARD. The
Biostatistics Division (BD) is included in the OCAC as required by the CIDAR program announcement,
although, given the central role of Biostatistics in this center, this division will, in many ways, function as a
core. The Biostatistics Division will be a central resource used by all projects and cores. This division will
provide expertise in the translation of clinical hypotheses into testable statistical hypotheses, selection of
efficient study designs and measurement protocols, estimation of sample size requirements, acquisition and
management of data, statistical analysis, and final report preparation. The Biostatistics Division will be codirected
by Drs. Succop and Arndt. The divisions of the OCAC will provide organizing and integrating
functions over all of the remaining cores and projects.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
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批准号:7637870
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依托单位:
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依托单位:
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依托单位:
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依托单位:
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财政年份:2007
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负责人:STEPHEN M STRAKOWSKI
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依托单位:
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财政年份:2007
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依托单位:
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财政年份:2007
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负责人:STEPHEN M STRAKOWSKI
-
依托单位:
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依托单位:
海外基金