Operations and Clinical Assessment Core

运营和临床评估核心

• 批准号: 8099708
• 负责人: STEPHEN M STRAKOWSKI
• 金额: $ 63.11万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8099708
• 关键词: Administrative Personnel; Advisory Committees; Biometry; Clinical; Clinical assessments; Data Base Management; Ensure; Evaluation; Goals; Informed Consent; Measurement; NIH Program Announcements; Patient Recruitments; Preparation; Protocols documentation; Reporting; Research Design; Resources; Role; Sample Size; Statistical Data Interpretation; Translations; data management; human subject; meetings; operation

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.

操作和临床评估核心（OCAC）满足了CIDAR中描述的所需核心 计划公告（PA05-039）。 OCAC将提供三个主要功能：1）整体中心 行政; 2）受试者招聘和评估； 3）数据库管理和统计 分析。因此，OCAC已分为与这些专业相对应的三个部门 功能。每个部门都有专门分配的主任，以确保为此的目标和目标 划分被满足；这些董事向斯特拉科夫斯基博士报告，后者还将担任OCAC董事 担任BITREC总监的角色。行政部门将提供BITREC的整体管理； 为了实现这一目标，它将由BITREC主任，指导委员会，两个外部咨询 委员会和行政人员。 Strakowski博士将指导这个部门，与他的角色一致 OCAC和BITREC主任。 OCAC的临床评估和招聘部（卡）将 提供患者招聘，知情同意和人类受试者的监管职能以及初始 评估。我们选择集中这些功能以集成项目并维护 跨项目的一致主题管理和评估。 Delbello博士将指导卡。这 OCAC中包括CIDAR计划公告的OCAC中，生物统计局（BD）包括在OCAC中 尽管鉴于生物统计学在该中心的核心作用，但该分裂在许多方面都将起作用 核。生物统计局将是所有项目和核心使用的中央资源。这个部门会 在将临床假设转化为可检验的统计假设方面提供专业知识，选择 有效的研究设计和测量协议，样本量需求的估计，采集和 数据管理，统计分析和最终报告准备。生物统计局将被编码 由Drs。 Succop and arndt。 OCAC的划分将提供组织和整合 在所有其余的核心和项目上的功能。