Data Management and Biostatistics Core

数据管理和生物统计核心

• 批准号: 8302217
• 负责人: Maganizo Chagomerana
• 金额: $ 26.27万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8302217
• 关键词: Adherence; Bioinformatics; Biostatistics Core; Case Report Form; Clinical Research; Computer software; Confidentiality; Core Facility; Data; Data Analyses; Data Base Management; Data Collection; Data Coordinating Center; Data Quality; Data Security; Database Management Systems; Databases; Development; Disease; Environment; Future; Goals; Human Resources; Human Subject Research; Information Technology; Intervention; Maintenance; Malaria; Malawi; Manuscripts; Medicine; Mentors; Michigan; Monitor; Play; Preparation; Procedures; Process; Protocols documentation; Recruitment Activity; Regulation; Reporting; Research; Research Activity; Research Design; Research Personnel; Research Project Grants; Retrieval; Sampling; Security; Site; Southern Africa; Specialist; Standardization; System; Testing; Training; Universities; Update; Work; college; data management; design; high standard; meetings; operation; programs; protocol development; research and development; software development; therapy design

The goal of the Data Management and Biostatistics (DMB) Core is to develop a susteinable capacity to collaborate with investigators conducting malaria research. The Core will be key in producing and managing high quality data to evaluate malaria control interventions in the future. Specifically, the Core will create an information technology (IT) environment to host a data management system, provide assistance with protocol development and study design, plan and manage projects, assure data quality and adherence to study protocols, and provide both data management and analysis. The Core aims to mentor researchers and will develop short courses in clinical research, data management and data analysis. The DMB Core will be subdivided in one central office in Blantyre and two study site offices in Chikwawa and Thyolo. Since the third study site is in Blantyre, the personnel to perform site activities for Blantyre will be located at the central office. The central office will be coordinate activities related to study design, protocol development, case report form development, study reports, protocol adherence, standardization of procedures, designing and programming databases, and statistical analysis. A team comprised of the Core Leader (who is also a statistician), Maganizo Chagomera, a Project Manager, an IT specialist, and a Data Manager I I/Programmer will be working in the central office at the College of Medicine. In the site offices, a Project Research Coordinator and a Data Manager I will be working in data capture, correcting errors and assisting with study conduct. The Malawi team will be supported by experts in data coordinating center activities organized into two committees - an Executive Committee, responsible for providing assistance to the Core leader with dayto-day operations until the core matures, and an External Advisory Board. These experts will mentor and monitor the work of the core. The Data Management System used in the Core will be REDCap, software developed by a consortium led by Vanderbilt University. The software is compliant with confidentiality and security regulations, but lacks a few required features. The Core will work with a developer from a bioinformatics core facility at Michigan State University to customize REDCap for this ICEMR..

数据管理和生物统计（DMB）核心的目标是发展与开展疟疾研究的研究人员合作的可持续能力。该核心项目将是生产和管理高质量数据以评估未来疟疾控制干预措施的关键。具体而言，核心将创建一个信息技术（IT）环境来托管数据管理系统，为协议开发和研究设计提供协助，计划和管理项目，确保数据质量和遵守研究协议，并提供数据管理和分析。该核心旨在指导研究人员，并将开发临床研究、数据管理和数据分析方面的短期课程。DMB核心将细分为位于布兰太尔的一个中心办公室和位于奇克瓦瓦和Thyolo的两个研究站点办公室。由于第三个研究地点在布兰太尔，为布兰太尔执行现场活动的人员将位于中央办公室。中央办公室将协调与研究设计、方案制定、病例报告表制定、研究报告、方案遵守、程序标准化、数据库设计和编程以及统计分析相关的活动。一个由核心领导（也是统计学家）、Maganizo Chagomera、项目经理、IT专家和数据经理I/ I/程序员组成的团队将在医学院的中央办公室工作。在现场办公室，一名项目研究协调员和一名数据经理将负责数据采集，纠正错误并协助研究进行。马拉维小组将得到数据协调中心活动方面的专家的支持，这些活动分为两个委员会：一个是执行委员会，负责向核心领导人提供日常业务援助，直到核心成熟；另一个是外部咨询委员会。这些专家将指导和监督核心的工作。核心使用的数据管理系统将是REDCap，由范德比尔特大学领导的一个财团开发的软件。该软件符合保密和安全法规，但缺乏一些必需的功能。Core将与密歇根州立大学生物信息学核心设施的开发人员合作，为该ICEMR定制REDCap。