Data Managemet and Statistical Core

数据管理和统计核心

• 批准号: 8494545
• 负责人: Daniel J. Tisch
• 金额: $ 4.99万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8494545
• 关键词: Africa South of the Sahara; Agreement; Architecture; Archives; Area; Asia; Biological; Biometry; Biostatistics Core; Clinical Research; Clinical Trials; Collaborations; Collection; Complex; Computer software; Confidentiality; Country; Culicidae; Data; Data Analyses; Data Base Management; Data Collection; Data Coordinating Center; Data Set; Data Storage and Retrieval; Databases; Development; Diagnostic; Diagnostic tests; Educational workshop; Ensure; Environment; Epidemiology; Ethics; Future; Goals; Good Clinical Practice; Human; Human Resources; Individual; Infection; Information Systems; Institution; Institutional Review Boards; Laws; Malaria; Modeling; Molecular; Online Systems; Papua New Guinea; Participant; Plasmodium; Pregnancy; Privacy; Procedures; Province; Publications; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Risk; Sampling; Secure; Site; Solomon Islands; Solutions; System; Testing; TimeLine; Training; Vivax Malaria; base; cohort; data integrity; data management; data sharing; design; epidemiology study; follow-up; human subject; programs; relational database; repository; tool; transmission process

The Data Management and Biostatistics Core will build the physical infrastructure, software solutions and human resources for a centralized, web-based fully GCP-compliant data management system and a program-wide data warehouse and provide support for the analyses of complex longitudinal data systems. The Core will serve the data storage and analytic needs of the 3 Research Projects conducted in all malaria endemic sites ofthe ICEMR and interact directly with the Molecular Diagnostics Core that will create an archive of biological samples and perform diagnostic tests related to malaria infections of humans and mosquitoes. The Specific Aims are to: 1: Set up a robust and comprehensive, centralized, web-based fully GCP-compliant data management system for ICEMR program 2; Create a collaborative environment between Papua New Guinea and participating sites in Solomon Islands and other ICEMR institutions and countries for the design, development, testing, and implementation of the data management system 3: Establish a centralized data repository that provides secure access to researchers and collaborators 4: Develop adequate data analysis tools for the analyses of complex longitudinal datasets (with multiple endpoints) 5: Analyze data and prepare results in a timely manner for interim analyses, publications, and presentations 6; Ensure regulatory compliance of data collection management 7: Provide training and development opportunities to Papua New Guinea and Solomon Islands in the areas of epidemiology, biostatistics, and database architecture The core will be directed by Prof. John Aponte from CRESIB, where he has organized similar data systems for large scale malaria epidemiology studies and clinical trials in Sub-Saharan Africa, and supported by Dr. Ivo Mueller, leader ofthe Epidemiology Project, and Thomas Adiguma, senior data manager at PNGIMR. Infrastructure and capacity building will be accomplished by the provision of training and resources in the fields of epidemiology, biostatistics, and dataset architecture.

数据管理和生物统计学核心将建立物理基础架构，软件解决方案和 基于集中式网络的完全符合GCP的数据管理系统的人力资源和 范围内的数据仓库，并为复杂纵向数据系统的分析提供支持。 核心将满足所有疟疾中3个研究项目的数据存储和分析需求 ICEMR的地方性部位，并与分子诊断核心直接相互作用，该核心将创建一个 生物样品的存档并进行与人类和人类疟疾感染有关的诊断测试 蚊子。具体目的是： 1：建立一个强大而全面的，集中的，基于网络的完全符合GCP的数据管理 ICEMR程序系统 2;在巴布亚新几内亚和所罗门的参与地点之间创建一个协作环境 岛屿和其他ICEMR机构以及设计，开发，测试和实施的国家 数据管理系统 3：建立一个集中式数据存储库，可为研究人员和合作者提供安全的访问 4：为复杂纵向数据集的分析开发足够的数据分析工具（有多个 终点） 5：分析数据并准备及时的结果进行临时分析，出版物和演示文稿 6;确保数据收集管理的监管合规性 7：为巴布亚新几内亚和所罗门群岛提供培训和发展机会 流行病学，生物统计学和数据库体系结构 核心将由Cresib的John Aponte教授指导，他在那里组织了类似的数据系统 用于大规模的疟疾流行病学研究和撒哈拉以南非洲的临床试验，并得到博士的支持。 流行病学项目的负责人Ivo Mueller和PNGIMR的高级数据经理Thomas Adiguma。 基础架构和能力建设将通过提供培训和资源来完成 流行病学，生物统计学和数据集体系结构领域。