The goal of the Data Management and Biostatistics (DMB) Core is to develop a susteinable capacity to collaborate with investigators conducting malaria research. The Core will be key in producing and managing high quality data to evaluate malaria control interventions in the future. Specifically, the Core will create an information technology (IT) environment to host a data management system, provide assistance with protocol development and study design, plan and manage projects, assure data quality and adherence to study protocols, and provide both data management and analysis. The Core aims to mentor researchers and will develop short courses in clinical research, data management and data analysis. The DMB Core will be subdivided in one central office in Blantyre and two study site offices in Chikwawa and Thyolo. Since the third study site is in Blantyre, the personnel to perform site activities for Blantyre will be located at the central office. The central office will be coordinate activities related to study design, protocol development, case report form development, study reports, protocol adherence, standardization of procedures, designing and programming databases, and statistical analysis. A team comprised of the Core Leader (who is also a statistician), Maganizo Chagomera, a Project Manager, an IT specialist, and a Data Manager I I/Programmer will be working in the central office at the College of Medicine. In the site offices, a Project Research Coordinator and a Data Manager I will be working in data capture, correcting errors and assisting with study conduct. The Malawi team will be supported by experts in data coordinating center activities organized into two committees - an Executive Committee, responsible for providing assistance to the Core leader with dayto-day operations until the core matures, and an External Advisory Board. These experts will mentor and monitor the work of the core. The Data Management System used in the Core will be REDCap, software developed by a consortium led by Vanderbilt University. The software is compliant with confidentiality and security regulations, but lacks a few required features. The Core will work with a developer from a bioinformatics core facility at Michigan State University to customize REDCap for this ICEMR..
Growing quality demands in human subjects research and the complexity of data management and analysis have resulted in a constituency of data coordinating centers to support studies in which specialized professionals can provide the necessary assistance to conduct multi-center studies. In Southern Africa, no coordinated effort with data management and data analysis to support malaria research exists. A data coordinating center will be needed to assess upcoming interventions designed to control malaria.
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