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Abstract

An improved system for tracking the progress of a clinical study includes a classifier generator, a classifier application subsystem, a study stage annotation subsystem, a progress status models generator, an aggregation module, and a progress status evaluation subsystem. The classifier generator automatically generates clinical data element classifiers by evaluating clinical data containers and clinical study stage attributes across clinical studies; the classifier application subsystem applies the clinical data element classifiers to classify clinical data elements into pre-determined categories; the study stage annotation subsystem uses the clinical data element classifiers and the classified clinical data elements to determine clinical study stages; the progress status models generator generates at least one progress status model based on the clinical study stages, the aggregation module selects and aggregates the classified clinical data elements and clinical study stages; and the progress status evaluation subsystem computes the state of at least one progress status model. The progress status evaluation subsystem generates at least one progress status of the clinical study by using the clinical data element classifiers and clinical data to compare contextualized study properties of one or more associated clinical study stages. An improved method for tracking the progress of a clinical study is also described and claimed.

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