The Data Management and Statistics Core (FSC)

数据管理和统计核心 (FSC)

• 批准号: 9489087
• 负责人: Elizabeth C. Matsui
• 金额: $ 6.71万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9489087
• 关键词: Asthma; Biological Assay; Childhood Asthma; Chronic Obstructive Airway Disease; Clinical; Clinical Data; Clinical Research; Clinical Trials; Code; Complex; Data; Data Analyses; Data Collection; Data Files; Data Reporting; Data Set; Database Management Systems; Databases; Development; Diet; Disclosure; Eligibility Determination; Enrollment; Ensure; Environmental Exposure; Funding; Health Insurance Portability and Accountability Act; Information Systems; Knowledge; Laboratories; Lung diseases; Manuals; Manuscripts; Monitor; Obstructive Lung Diseases; Online Systems; Participant; Performance; Poverty; Preparation; Procedures; Process; Prospective cohort study; Protocols documentation; Quality Control; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Role; Running; Rural; Schedule; Security; Series; Source; Specimen; Statistical Data Interpretation; Statistical Methods; Statistical Models; Structure; System; Testing; Time; Training; United States National Institutes of Health; Visit; Work; Writing; data archive; data integrity; data management; design; experience; follow-up; handbook; instrument; meetings; operation; programs; respiratory health; statistics; web page; web site

Project Summary The Data Management and Statistics Core (DMSC) has been an active and key component supporting numerous studies of lung disease and environmental exposure disparities for more than 15 years, serving a critical role in: (1) integrating multiple types of study data from multiple sources; (2) ensuring that the complex process of running multiple clinical studies is seamless; (3) developing and executing statistical analysis plans for complex longitudinal environmental exposure data; (4) leading discussion of data and analysis results among multiple investigators and Environmental Assessments Core (EAC) staff at weekly data management meetings; and (5) developing statistical methods to support multiple projects. The DMSC will continue to serve this same role in the proposed CURE COPD program, building on its infrastructure and experience from the past 15 years. DMSC staff has an in-depth understanding of the details of all of the clinical projects, as well as the Administrative Core (AC), EAC, and laboratories, which process the biologic specimens. This knowledge facilitates the DMSC's ability to manage the flow of data that occurs among these components. Without a DMSC, data management and analysis would have to be conducted within each study's infrastructure, making it difficult to leverage data management systems previously developed for other studies and that have been built and refined over the past 15 years. The DMSC also provides immediate access to advanced statistical support by Program investigators and staff. By pooling resources to support a DMSC, dedicated staff can be supported and continue to create systems which serve the needs of multiple studies, as well as the needs of the AC, the EAC, and the support laboratories. Further, these systems provide the underlying structure that will integrate all components of the Program, as many of the systems that are already in place are specifically designed to facilitate transfer, management and analysis of data among program components.

项目摘要 数据管理和统计核心（DMSC）一直是支持的关键组件 大量研究肺部疾病和环境暴露差异已有15年以上，服务于 至关重要的作用：（1）从多个来源整合多种类型的研究数据； （2）确保综合体 进行多项临床研究的过程是无缝的。 （3）制定和执行统计分析计划 用于复杂的纵向环境暴露数据； （4）主要讨论数据和分析结果 在多个调查人员和环境评估中，核心（EAC）员工在每周数据管理中 会议； （5）开发支持多个项目的统计方法。 DMSC将继续服务 在拟议的治疗COPD计划中，同样的角色是基于其基础架构和经验 过去15年。 DMSC员工对所有临床项目的细节有深入的了解，以及 处理生物标本的行政核心（AC），EAC和实验室。这个知识 促进了DMSC管理这些组件之间发生的数据流的能力。没有一个 DMSC，数据管理和分析必须在每个研究的基础架构中进行，使 很难利用以前用于其他研究的数据管理系统，并且 在过去的15年中建造和完善。 DMSC还可以立即访问高级统计 计划调查员和员工的支持。通过汇总资源来支持DMSC，敬业的员工可以是 支持并继续创建满足多项研究需求的系统，以及 AC，EAC和支持实验室。此外，这些系统提供了基础结构 集成程序的所有组件，因为已经有许多已经到位的系统是专门的 旨在促进程序组件之间数据的传输，管理和分析。