Drug Induced Liver Injury Network Data Coordinating Center

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ABSTRACT The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has proposed the continuation of the Drug-Induced Liver Injury Network (DILIN). As described in the RFA, DILIN will be a network composed of up to 5 Clinical Centers (CCs) with expertise in diagnosis and management of DILI and a Data Coordinating Center (DCC) with expertise in the management of multicenter studies and clinical and translational datasets. The major aim of the network study is to pursue genetic analyses to find predictive biomarkers as well as genetic "fingerprints" useful for elucidating the pathogenesis of Drug-Induced Liver Injury (DILI) and ultimately for developing specific means of prevention and or treatment. 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 DILIN network. In particular, we will attend to the following specific aims: (1) Support the network’s effort to increase recruitment productivity and efficiency; (2) Support current and new DILIN studies including new mechanistic studies and/or trials; (3) Provide overall network support of general DILIN functions; (4) Ensure quality assurance and continue data management activities; and (5) Administer subcontracts with external partners including the analytical core at the National Center for Natural Products Research.