Research Project
9497755
Core B: Summary A well integrated data management system was established during the first funding period of this TMRC program. In this second round of the program i.e. the current funding period, we have been able to achieve our goal of establishing a Health and Demographic Surveillance System (HDSS) in the Muzaffarpur district through which ongoing monitoring of the population and associated health/disease data is maintained. We propose to maintain the HDSS during the next 5 years, and continue the HDSS as an entity that will eventually become independent of this TMRC. In this renewal request, we propose to extend the capacity of the Data Management core to establish a bioinformatics unit to support analyses of the large databases that are being accumulated in all 3 projects. The core will continue to process and maintain data on parasite loads and HLA type for many subjects in the HDSS. As such, maintenance and constant improvement of the data management procedures, and innovative approaches to biostatistical and bioinformatic analyses, are warranted. Goals of the 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. The use of specimens and distribution between investigators of different projects will be catalogued through the specimen control system, managed by the head of the specimen control. 3. To provide support and quality control mechanisms for HDSS core and other research projects. This will include the development and revision of Standard Operating Procedures (SOPs), 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. 5. To develop and establish expertise and support in bioinformatics, including analytic methods for metabolomes, transcriptomes and microbiomes. The system is designed to allow BHU to carry out FDA-compliant clinical trials or vaccine studies in the future.
