The goal of the Data Management and Biostatistics Core (DMBC) is to create an autonomous and sulf- sufficient data coordinating center to support optimal design, conduct and analysis of the malaria research carried out within the Malawi ICEMR network. Specifically, the Core will update and expand the current network; continue to upgrade, develop and customize the Data Management System based on REDCap; develop a more comphrehensive and reliable sample tracking system; extend and intensify monitoring of study conduct and data quality; increase the capacity to provide biostatistics support; enforce and extend use of secure repositories to file documents and programs; provide mentoring and training to DMBC staff and investigators; maintain and expand the staff of the DMBC to meet requirements for the new project activities. The DMBC will be housed in the Malaria Alert Centre (MAC) on the campus of the University of Malawi College of Medicine, with satellite facilities in the index health centres in Chikhwawa, Phalombe and Karonga. The Malawi team will expand to include a Data Core Leader, 3 Data Managers, 3 Data Coordinators, 2 Data Entry Clerks, amd 1 IT technician. The Malawi team will be supported by a Data Analyst, a contracted SAS programmer, a Data Core Advisor, a Data Management Expert, and a contracted developer. Data will be collected via passive case detection at health centers, active case detection at/near households, during household assessments (for net integrity and to collect mosquitoes) and from laboratory assays (entomological, molecular, immunological). Nearly all data will be captured directly in computers or on tablets. Interfaces between REDCap and the Demographic Health Surveillance system will ensure that data collectors can identify study subjects promptly and accurately. An offline GPS system will allow field workers to locate scheduled mosquito capture points. Data from the field sites will be transmitted to a cloud server through the cell phone network; laboratory data will be transmitted via Ethernet connections. The sample tracking system will use Freezerworks. Data quality assurance and quality control activities will start in the field, even before data are synchronized from tablets, and will continue via regular monitoring, query, and metrics reports. All processes and procedures will be tested before the studies start and will be detailed in Data Management Plans. The Core will also support ICEMR investigators in designing, planning and conducting studies so that all projects comply with high standards of data quality and by providing statistical support for study design, study reporting, and with interim and final analyses. The research projects supported by the DMBC will successfully address scientific questions while complying with all regulatory standards.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1)
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Michigan State University
East Lansing
United States
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