Data Managemet and Statistical Core

数据管理和生物统计核心将建立物理基础设施、软件解决方案和 用于集中式、基于网络的完全符合GCP的数据管理系统的人力资源和 支持整个方案的数据仓库，并为复杂纵向数据系统的分析提供支持。 核心将满足在所有疟疾领域开展的3个研究项目的数据存储和分析需求 ICEMR的流行地点，并直接与分子诊断核心互动，这将创建 对生物样本进行存档，并进行与人类和 蚊子。具体目标是： 1：建立强大、全面、集中化、基于Web的完全符合GCP的数据管理 ICEMR计划系统 2；在巴布亚新几内亚和所罗门的参与地之间创造一个协作环境 岛屿和其他ICEMR机构和国家/地区的设计、开发、测试和实施 数据管理系统的 3：建立集中式数据存储库，为研究人员和合作者提供安全访问 4：开发足够的数据分析工具，用于分析复杂的纵向数据集(具有多个 端点) 5：为中期分析、出版物和演示文稿及时分析数据和准备结果 确保数据收集管理的合规性 7：在这些地区向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架构 核心将由CRESIB的John Aponte教授指导，他曾在CRESIB组织过类似的数据系统 在撒哈拉以南非洲进行大规模疟疾流行病学研究和临床试验，并得到Dr。 流行病学项目负责人Ivo Mueller和PNGIMR高级数据经理Thomas Adiguma说。 基础设施和能力建设将通过在以下方面提供培训和资源实现 流行病学、生物统计学和数据集架构领域。

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.