Biostatistics and Data Management Core

ICIDR项目是一项互动式努力，旨在通过一项针对妊娠期疟疾间歇推定治疗（IPTp）的四种方案的随机试验，研究孕期疟疾预防对母婴结局的影响。该方案的广泛和长期目标是确定更有效的治疗方法，以预防孕妇感染和患病，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卓越中心，对孕妇和儿童的抗疟疾药物进行干预性研究。数据管理和生物统计组件将为ICIDR计划的其他元素提供核心服务，确保数据的完整性和准确性

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.