Biostatistics and Data Management Core

生物统计和数据管理核心

• 批准号: 6969072
• 负责人: PATRICK E DUFFY
• 金额: $ 14.96万
• 依托单位: SEATTLE BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-07-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6969072
• 关键词: Africa; Internet; antimalarial agents; biomedical facility; chemoprevention; cooperative study; data management; human data; human therapy evaluation; longitudinal human study; malaria; microorganism disease chemotherapy; pregnancy infection; statistical service /center; statistics /biometry; women' s health

The ICIDR Program is an interactive endeavor to examine the impact of malaria prevention during pregnancy on mother-infant outcomes, in the context of a randomized trial of four regimens for Intermittent Presumptive Treatment against pregnancy malaria (IPTp). The broad, long-term objectives of the program are to identify more effective treatments to prevent malaria infection and disease in pregnant women, to understand the long-term impact of malaria prevention on the acquisition of protective immunity and malaria susceptibility in pregnant women and their infants, and to develop a center of excellence in Tanzania for interventional studies of antimalarial drugs in pregnant women and children. The Data Management and Biostatistics Components will provide core services to other elements of ICIDR Program, will ensure data integrity and security, and will facilitate timely reporting and publication. The Core has the following specific aims: 1) Execute an effective, secure Database Management System in support of research and capacity-building for the ICIDR, including database design, barcode tracking system, and a system double data entry and validation. 2) Migrate the ICIDR database web-based application, that will include digital signature, audit system, internet communication and VPN, and development of SOPs for database management and training. 3) Establish a Data and Safety Monitoring Board and DSMB charter to oversee and monitor interventional clinical trials. 4) Incorporate experienced Biostatistics support for study design and reporting, and reporting to the Data & Safety Monitoring Board. The Data Core in Morogoro will be fully autonomous, with a Data Manager and data entry team under the supervision of Dr. Mutabingwa.

ICIDR计划是一项互动努力，旨在研究孕期疟疾预防对母婴结局的影响，在四种治疗孕期疟疾的间歇性假定治疗(IPTp)的随机试验的背景下进行。该计划的广泛和长期目标是确定更有效的治疗方法来预防孕妇的疟疾感染和疾病，了解疟疾预防对孕妇及其婴儿获得保护性免疫和疟疾易感性的长期影响，并在坦桑尼亚建立一个孕妇和儿童抗疟疾药物干预研究的卓越中心。数据管理和生物统计部分将为ICIDR方案的其他要素提供核心服务，将确保数据完整性和 安全，并将促进及时报告和发布。核心有以下具体目标：1)执行有效、安全的数据库管理系统，以支持ICIDR的研究和能力建设，包括数据库设计、条形码跟踪系统以及系统双重数据录入和验证。2)迁移ICIDR数据库基于网络的应用程序，包括数字签名、审计系统、互联网通信和虚拟专用网，以及为数据库管理和培训开发标准操作程序。3)建立数据和安全监测委员会和数据和安全监测委员会章程，以监督和监测干预性临床试验。4)将经验丰富的生物统计学支持纳入研究设计和报告，以及报告 至数据与安全监测委员会。莫罗戈罗的数据核心将是完全自主的，在穆塔宾瓦博士的监督下有一个数据管理员和数据输入团队。