Table of Contents Author Guidelines Submit a Manuscript
BioMed Research International
Volume 2015, Article ID 976272, 10 pages
Research Article

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

1SRDC Software Research & Development and Consultancy Ltd., ODTU Teknokent Silikon Blok No. 14, 06800 Ankara, Turkey
2Department of Computer Engineering, Middle East Technical University, 06800 Ankara, Turkey
3Lombardia Informatica S.p.A., Via Torquato Taramelli 26, 20124 Milano, Italy
4F. Hoffmann-La Roche, 4070 Basel, Switzerland

Received 13 January 2015; Revised 14 May 2015; Accepted 18 May 2015

Academic Editor: Dipak Kalra

Copyright © 2015 A. Anil Sinaci et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases.