The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has proposed the continuation and expansion of the Drug-Induced Liver Injury Network (DILIN). As described in the RFA, DILIN will evolve into a network of up to 8 Clinical Centers (CCs), the Data Coordinating Center (DCC), and the NIDDK Project Office. The purpose of this research program is to enhance the enrollment of cases and controls from a wide demographic and geographic distribution, devise testable hypotheses to assess the role of genetic variability in DILI, perform pharmacogenetic analysis and develop the infrastructure needed to find phenotypic-genotypic associations, disseminate the information to the greater scientific community, and develop, in conjunction with the National Library of Medicine, an authoritative and complete internet website for drug-induced liver injury. The Duke Clinical Research Institute (DCRI) proposes to continue as the DCC for DILIN. In this role, we will apply our extensive experience and research infrastructure to coordinate, support and facilitate the activities of the network. In particular, we will attend to the following specific aims: (1) nurture the efficient organizational structure developed in the initial grant period;(2) invoke quality assurance procedures to ensure fidelity in conducting these studies;(3) integrate the new clinical centers into DILIN;(4) maintain data management systems developed in the initial grant period to safeguard the completeness, accuracy and timeliness of the accumulating data;(5) continue reports developed in the initial grant period to chart progress in conducting these studies;(6) contribute in a substantive manner to design and conduct of pharmacogenetic studies;(7) contribute to the NLM initiative to developed an authoritative DILI website;(8) contribute to the development of a validated, diagnostic instrument for DILI;(9) provide appropriate and capable leadership and expertise in biostatistics and study design;and (10) support ancillary studies and prospective studies.
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