A statistical metadata model for clinical trials' data management
Computer Methods and Programs in Biomedicine
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An integrated, semantically rich statistical metadatamodel is designed to cover the major stages of thestatistical information processing (data collection andanalysis including harmonization, processing of data andmetadata and dissemination/output phases), which canminimize complexity of data warehousing environmentsand compatibility problems between distributedStatistical Information Systems (SIS). The semantics ofthe model are analyzed, describing each part of thestatistical processing. In addition, process metadata(operators) for automatic manipulation of both data andmetadata are also defined over their common domain aswell as logistic metadata for the location and format ofdata. Furthermore, we discuss how the proposedframework can facilitate actual information entry andanalysis into a SIS. Finally, we demonstrate in a casestudy how the suggested metadata model can beimplemented and integrated into a modern metadata-enabled SIS, thus standardizing the processing environment and assuring the quality of statistical results.