title: A comprehensive clinical research database based on CDISC ODM and i2b2.
abstract: We present a working approach for a clinical research database as part of an archival information system. The CDISC ODM standard is target for clinical study and research relevant routine data, thus decoupling the data ingest process from the access layer. The presented research database is comprehensive as it covers annotating, mapping and curation of poorly annotated source data. Besides a conventional relational database the medical data warehouse i2b2 serves as main frontend for end-users. The system we developed is suitable to support patient recruitment, cohort identification and quality assurance in daily routine.
authors.affiliation: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors.forename: Frank A
authors.initials: FA
authors.lastname: Meineke
authors.affiliation: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Stäubert
authors.affiliation: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors.forename: Matthias
authors.initials: M
authors.lastname: Löbe
authors.affiliation: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors.forename: Alfred
authors.initials: A
authors.lastname: Winter
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration*; D066289:Data Curation / Q000379:methods*; D003628:Database Management Systems; D016208:Databases, Factual; D057286:Electronic Health Records / Q000458:organization & administration*; D005858:Germany; D063005:Health Information Systems / Q000458:organization & administration*; D016247:Information Storage and Retrieval / Q000379:methods*; D008498:Medical Record Linkage / Q000379:methods*