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.

Public Health Relevance

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.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Specialized Center (P50)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-AWA-M)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Banaras Hindu University
Zip Code
Sundar, Shyam; Chakravarty, Jaya (2015) An update on pharmacotherapy for leishmaniasis. Expert Opin Pharmacother 16:237-52
Malaviya, Paritosh; Picado, Albert; Hasker, Epco et al. (2014) Health & Demographic Surveillance System profile: the Muzaffarpur-TMRC Health and Demographic Surveillance System. Int J Epidemiol 43:1450-7
Mudavath, Shyam Lal; Talat, Mahe; Rai, Madhukar et al. (2014) Characterization and evaluation of amine-modified graphene amphotericin B for the treatment of visceral leishmaniasis: in vivo and in vitro studies. Drug Des Devel Ther 8:1235-47
Hasker, Epco; Malaviya, Paritosh; Gidwani, Kamlesh et al. (2014) Strong association between serological status and probability of progression to clinical visceral leishmaniasis in prospective cohort studies in India and Nepal. PLoS Negl Trop Dis 8:e2657
Singh, Om Prakash; Hasker, Epco; Sacks, David et al. (2014) Asymptomatic Leishmania infection: a new challenge for Leishmania control. Clin Infect Dis 58:1424-9
Kumar, R; Singh, O P; Gautam, S et al. (2014) Enhanced expression of Toll-like receptors 2 and 4, but not 9, in spleen tissue from patients with visceral leishmaniasis. Parasite Immunol 36:721-5
Kumar, Dinesh; Tiwary, Puja; Chakravarty, Jaya et al. (2014) Association of interleukin-18 gene polymorphism with susceptibility to visceral leishmaniasis in endemic area of Bihar, an Indian population. ScientificWorldJournal 2014:852104
Singh, Om Prakash; Sundar, Shyam (2014) Whole blood assay and visceral leishmaniasis: Challenges and promises. Immunobiology 219:323-8
Sudarshan, Medhavi; Sundar, Shyam (2014) Parasite load estimation by qPCR differentiates between asymptomatic and symptomatic infection in Indian visceral leishmaniasis. Diagn Microbiol Infect Dis 80:40-2
Gautam, Shalini; Kumar, Rajiv; Singh, Neetu et al. (2014) CD8 T cell exhaustion in human visceral leishmaniasis. J Infect Dis 209:290-9

Showing the most recent 10 out of 48 publications