Data Management & Biostatistics Core

Kamuzu University Of Health Sciences, Blantyre

Investigators

Abstract

The goal of the Data Management and Biostatistics Core (DMBC) is to create and maintain an autonomous and self-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 upgrade the current network; maintain and continue to develop a secure Data Management System based on REDCap, ODK and a Health and Demographics Surveillance System (HDSExplorer); 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 by conducting statistical analysis for manuscripts and training; enforce and extend use of secure repositories to file documents and programs; provide mentoring and training to DMBC staff and The DMBC is housed in the Malaria Alert Centre (MAC) on the campus of the Kamuzu University of Health Sciences. Staff will regularly visit the health facilities where data will be generated and collected. The Malawi team will be comprised of a Data Core Leader, two Biostatisticans, two Data Managers, two Data Coordinators, two Data Entry Clerks, one IT technician, and one Assistant IT Techinician. This team will be supported by an Advisor with vast experience in epidemiological and biostatistical work. Data will be collected via passive case detection at health centers, active case detection through a series of surveys, community and household visits for collection of mosquitoess, and through laboratory assays (entomological and molecular). All data will be captured directly in computers or on tablets, except clinical data from health facility registers that will be scanned and subsequently entered into an electronic database. Data will also be extracted from DHIS2. The integrated system based on REDCap, ODK and HDS Explorer has a robust search functionality that will facilitate data collectors to identify study subjects promptly and accurately. An offline GPS system will allow field workers to locate scheduled mosquito capture points. Data will be collected offline and will be daily transmited to a cloud server. The data capture system has quality assurance functionalities to prevent data errors during entry and synchronization. The Freezerworks® system will be used to track samples in the laboratory. In the upcoming years, the DMBC will work on customizing Baobab LIMS as an alternative open-source solution to replace the Freezerworks® system. The DMBC will work closely with investigators throughout the whole study cycle to ensure compliance with high standards of data quality. Design of data capture tools will be supported and quality assurance (QA) reports for monitoring data quality and study conduct will be automated. Queries will be promptly addressed. A system developed by the DMBC will conduct QA of qPCR data. Statistical support will be provided for data cleaning and analysis. In summary, the DMBC will continue to provide comprehensive support to ICEMR projects.