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.

运营和临床评估核心（OCAC）满足CIDAR中所述的核心要求 计划公告（PA 05 -039）。海外华人文化中心将发挥三大功能：1）总体中心 管理; 2）受试者招募和评估;以及3）数据库管理和统计 分析.因此，廉政公署分为三个部门，分别与这些主要部门相对应。 功能协调发展的每个部门都有一名专门负责确保该部门的目标和目的得到实现的主管。 这些董事向Strakowski博士报告，他将担任OCAC董事，除了他的 担任BITREC总经理。行政司将全面管理BITREC; 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 委员会和行政人员。Strakowski博士将领导这个部门，与他的角色一致， OCAC和BITREC主任。OCAC的临床评估和招募部门（CARD）将 提供患者招募、知情同意和人类受试者监管功能， 评估。我们选择集中这些职能，以便整合项目并维护 跨项目的一致主题管理和评价。德尔贝洛博士将指导卡。的 根据CIDAR计划公告的要求，生物统计部（BD）被纳入OCAC， 虽然，鉴于生物统计学在该中心的中心作用，该部门将在许多方面发挥作用， 核心生物统计司将是所有项目和核心使用的中心资源。此部门将 提供专业知识，将临床假设转化为可检验的统计假设， 有效的研究设计和测量方案，估计样本量要求，采集和 数据管理、统计分析和最终报告编制。生物统计司将由 苏克普和阿恩特医生的OCAC的各个部门将提供组织和整合 在所有剩余的核心和项目上运行。