A well-integrated data management system was established during the first funding period of this TMRC program. In this request for renewal ofthe program, we plan to expand data collection to include establishment of a Data Surveillance System (DSS) through which ongoing monitoring ofthe population and associated health/disease data can be maintained during and beyond the grant funding period. We will also establish systematic typing procedures through a Molecular Core, maintaining data on parasite loads and HLA type for many subjects in the DSS. As such, maintenance and constant improvement of the data management procedures, and innovative approaches to biostatisticalanalyses, are crucial. Goals ofthe Data and Biostatistics core are: 1. To maintain full in-house data management capacity at BHU in Varanasi and its associated field site in Muzaffarpur, Bihar State. This includes maintenance and quality control of an electronic data management system operating at BHU. 2. To maintain a record of specimens through the data management system, linking specimens to the database and to HLA and qPCR status obtained through Core D (molecular typing). The use of specimens and distribution between investigators on the four projects will be catalogued through the specimen control system, managed by the director of specimen control. 3. To provide support and quality control mechanisms for each of the two cores and four research projects. This will include the development of Standard Operating Procedures (SOPs) for clinical studies, specimen collection, specimen handling, data management and clinical monitoring procedures. 4. To provide expertise and support in biostatistics, allowing ongoing analysis of programs and feedback to regarding SOPs and data management. The system is designed to allow BHU to carry out FDA-compliant clinical trials or vaccine studies in the future.
A well maintained and improved Data Management System is essential to meet overall objectives ofthe projects and cores. Data Management and Biostatistics Core will record and manage the data collected through DSS and will help other projects and cores to get their sample population and data.
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