The main goal of the Data Management and Biostatistics (DMB) Core is to develop a West/Central African independent center capable of collaborating with malaria investigators in producing malaria research with high standards. More specifically, the Core will aim to complement existing information technology to create a safe envinnronment capable of maintaining a Data Management System compliant with adequate standards of confidentiality, security, and quality control To facilitate communications, the core will also maintain appropriate Internet connections between investigators and the DMB Core staff in all study sites. Additionally, the Core will aim to provide support to investigators in study planning and conduct activities, in data management, and in study design, protocol development and data analysis. The DMB Core will be responsible for training and re-training investigators in study procedures and for providing short courses to investigators. The Data Management and Biostatistics core will be comprised of one central office (at the University of Bamakoi) and offices at the fours study sites (Basse, Thies, Dioro, and Kenieroba). In the central office, project management (study planning, development of study material, study metric reports, and assessment of adherence to study protocol) will be carried out by a Project Manager and a Clinical Research Coordinator, and data analysis will be conducted by a Statistician/Data Analyst. Programming and mantaining data bases, and producing study reports will be conducted by a Data Manager Il/Programmer. In the site offices, assistance with study conduct and IRB will be provided by Project Research Coordinators, supervised by the Data Manager. Data Management activities at the sites, including continuous inspection of case report forms, data entry, and resolution of errors will be performed by a Data Manager I. The core will work with StudyTRAX as the Data Management System. StudyTRAX is compliant with security and confidentiality federal regulations, and has several features to assure data quality and protocol adherence. This software has been used by several data coordinating centers, including one in the NIH-funded Center of Excellence of Parkinson Disease. Training will be provided to core members through web-based courses, seminars, short courses and mentoring by committees of experts.

Public Health Relevance

Although CentralA/Vest Africa has one of the highest incidences of malaira and most advanced infrastructures and resources to conduct malaria research, there has been no coordinated data management and statistics infrastructure to support these groups. With growing international interest in malaria research, a strong African DMB Core could have great impact in malaria research. We propose a center comprised of the three most important West African countries in the malaria scenarium.

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-AWA-M)
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Tulane University
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