Designing the reconciled schema for a pharmacovigilance data warehouse through a temporally-enhanced ER model

Pharmacovigilance is the activity related to the collection, analysis, and prevention of adverse reactions induced by drugs. The spontaneous reporting of adverse drug reactions is a system for identifying and sending reports about unexpected reactions to the regulatory authority. In Italy the information needed for properly carrying out the pharmacovigilance activities is scattered in different databases, which often contain the same information but encoded in different and temporally evolving ways. The data contained in the mentioned archives need to be integrated with information contained in other databases. In this paper we describe the construction of a data warehousing system, called VigiSegn, for the national center of pharmacovigilance; in particular, we focus on the data sources analysis and the design of the reconciled database. The (temporal) schema of reconciled data has been designed by using the TimeER conceptual data model.