Biostatistics and Data Management Core

ICIDR 计划是一项互动项目，旨在研究怀孕期间预防疟疾对母婴结局的影响，并在对四种妊娠期疟疾间歇性推定治疗 (IPTp) 方案进行随机试验的背景下进行。该计划的广泛、长期目标是确定更有效的治疗方法来预防孕妇疟疾感染和疾病，了解疟疾预防对孕妇及其婴儿获得保护性免疫力和疟疾易感性的长期影响，并在坦桑尼亚建立一个针对孕妇和儿童抗疟药物介入研究的卓越中心。数据管理和生物统计组件将为 ICIDR 计划的其他要素提供核心服务，确保数据完整性和 安全，并将有助于及时报告和发布。该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双重数据输入和验证系统。 2) 将 ICIDR 数据库迁移到基于 Web 的应用程序，其中包括数字签名、审计系统、互联网通信和 VPN，以及数据库管理和培训 SOP 的开发。 3) 建立数据和安全监测委员会和 DSMB 章程来监督和监测介入性临床试验。 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 提交给数据与安全监控委员会。莫罗戈罗的数据核心将完全自主，并在 Mutabingwa 博士的监督下设有数据经理和数据输入团队。

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.