Data Management and Biostatistics Core

数据管理和生物统计核心

• 批准号: 8878994
• 负责人: Maganizo Chagomerana
• 金额: $ 22.82万
• 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 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8878994
• 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; Multicenter Studies; 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核心的目标是发展与进行疟疾研究的调查人员合作的可持续能力。该核心将是制作和管理高质量数据以评价今后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，以托管数据管理系统，为方案开发和研究设计提供帮助，计划和管理项目，确保数据质量和遵守研究方案，并提供数据管理和分析。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的短期课程。DMB核心将细分为一个中心办公室（位于布兰太尔）和两个研究中心办公室（位于Chikwawa和Thyolo）。由于第三个研究中心位于布兰太尔，因此执行布兰太尔研究中心活动的人员将位于中心办公室。中心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、方案依从性、程序标准化、数据库设计和编程以及统计分析相关的活动。一个由核心领导人（也是统计学家）、项目经理、IT专家和数据经理II/程序员Maganizo Chagomera组成的团队将在医学院的中央办公室工作。在研究中心办公室，一名项目研究协调员和一名数据经理I将负责数据采集、纠正错误并协助研究开展。马拉维团队将得到数据协调中心活动专家的支持，这些活动分为两个委员会：一个是执行委员会，负责在核心成熟之前向核心领导人提供日常运营方面的援助，另一个是外部咨询委员会。这些专家将指导和监测核心小组的工作。堆芯中使用的数据管理系统将是REDCap，这是由范德比尔特大学牵头的一个财团开发的软件。该软件符合保密和安全规定，但缺乏一些必要的功能。核心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。