Biostatistics and Data Management Core

Seattle Biomedical Research Institute, Seattle WA

Investigators

Linked publications & trials

Abstract

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.