Case-Reported Data Management Methodology Using an RDF Data Model for Building a Multicenter Clinical Registry

Abstract

In multicenter clinical research, case-reported clinical data are managed for each research project. Participating institutions manage the mapping between standardized codes and in-house codes. To use the data extracted from electronic medical records in case report forms, it is necessary to pay attention to the gap in the semantic hierarchy. Managing mapping information between in-house and standardized codes is centralized in Resource Description Framework (RDF) stores. The relationship between standardized and in-house codes is described in RDF and stored in RDF stores. RESTful APIs for accessing RDF stores in SPARQL was developed and verified. The relationship between standardized codes and in-house codes of pharmaceuticals was expressed in RDF triples. As a +result of the operational verification of the implemented APIs, it was confirmed that data management with knowledge bases expressed in RDF graphs is possible. The ability to dynamically modify mapping definitions enables flexible data management and ease of operational restrictions.