The US National Institutes of Health (NIH) includes 27 institutes and centers, many of which conduct clinical research. Previously, data collected in research trials has existed in multiple, disparate databases. This paper describes the design, implementation and experience to date with the Biomedical Translational Research Information System (BTRIS), being developed at NIH to consolidate clinical research data. BTRIS is intended to simplify data access and analysis of data from active clinical trials and to facilitate reuse of existing data to answer new questions. Unique aspects of the system includes a Research Entities Dictionary that unifies all controlled terminologies used by source systems and a hybrid data model that unifies parts of the source data models and include other data in entity-attribute value tables. BTRIS currently includes over 300 million rows of data, from three institutes, ranging from 1976 to present. Users are able to retrieve data on their own research subjects in identified form as well as deidentified data on all subjects.
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