Data Management and Biostatistics Core

数据管理和生物统计核心

• 批准号: 8376882
• 负责人: Maganizo Chagomerana
• 金额: $ 21.77万
• 依托单位: MICHIGAN STATE 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/8376882
• 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)核心的目标是发展一种可行的能力，与进行疟疾研究的调查人员合作。核心将是产生和管理高质量数据以评估未来疟疾控制干预措施的关键。具体地说，核心将创建一个信息技术(IT)环境，以托管数据管理系统，协助制定协议和研究设计，规划和管理项目，确保数据质量和遵守研究协议，并提供数据管理和分析。该中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核心将细分为设在布兰太尔的一个中心办公室和设在奇夸瓦和Thyolo的两个研究现场办公室。由于第三个研究地点在布兰太尔，为布兰太尔开展现场活动的人员将设在中心办公室。中心办公室将协调与研究设计、方案制定、案例报告表编制、研究报告、遵守方案、程序标准化、数据库设计和编程以及统计分析有关的活动。一个由核心领导(同时也是一名统计员)、Maganizo Chagomera、一名项目经理、一名IT专家和一名数据经理I/程序员组成的小组将在医学院的中心办公室工作。在现场办公室，一名项目研究协调员和一名数据管理员I将负责数据采集、纠正错误和协助进行研究。马拉维小组将得到数据协调中心活动专家的支持，该中心活动分为两个委员会--一个执行委员会，负责在核心成熟之前向核心领导提供日常运作方面的协助，以及一个外部咨询委员会。这些专家将指导和监督核心的工作。核心中使用的数据管理系统将是由范德比尔特大学牵头的一个财团开发的软件RedCap。该软件符合保密和安全规定，但缺乏一些必要的功能。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ICEMR定制RedCap。