The Bihar Tropical Medicine Research Center will unite a multi-national group of investigators studying critical aspects of human infection with the protozoan Leishmania donovani in an endemic region of northern India. Projects will focus on the clinical and epidemiological aspects of visceral leishmaniasis (project 1), human immune responses during progressive disease (project 2) and genetic factors governing susceptibility to infection (project 3). Subjects and data/specimen collection will be done through project 1, which will provide material for analyses done in all three projects. A data management core will be set up to support the three projects in the Bihar State Tropical Medicine Research Center. Westat will initiate the data entry and management systems, and set up means to interface with analytical statistical methods required for each of the three projects. Currently, most data collection, transfer and analysis at BHU sites is done by hard copy paper forms, which are entered into Microsoft Excel or Access databases prior to data analysis. These methods have limited security, and they do not allow for an audit trail. 1. The primary aim of the Data Management Core is to establish data management capacity at Banaras Hindu University (BHU) and its associated field site in order to successfully manage the data generated in the three TMRC projects as well as clinical and epidemiological research studies that BHU is planning to carry out in the future. 2. The secondary aims are to establish electronic data management systems that are secure and leave an audit trail, and to develop operations manuals as well as SOPs for data management. 3. The systems will provide support that will facilitate statistical analyses of epidemiologic, immunologic, and genetics data, but also for immunological data collected as part of the research projects.
We aim to initiate a system that will support not only the current proposed projects, but also set up a site that will be poised for future studies of vaccine candidates and therapeutic interventions in this fatal disease.
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