A Web-based Tool for Patients Cohorts and Clinical Trials management P. FRACCARO a and Mauro GIACOMINI a,1 a Dept. of communication, computer and system sciences (DIST) University of Genoa Abstract. Clinical Trials (CTs) play an increasingly important role in modern medicine. Often these types of studies, especially in the final phases, require collaboration between several hospitals, laboratories and institutions in different places or countries. The solution proposed is a template which exploits the principles of Networked Clinical Research and the strengths of Clinical Data Management Systems (CDMSs) commonly used (Electronic Data Capture (EDC), Electronic Medical Record (EMR) and Electronic Health Record (EHR). Therefore, the basic structure is a highly normalized and standardized database which is managed by a web platform and, only by recording the required information and developing web pages starting from predefined templates, it is possible to carry out new projects. The result is a hybrid CDMS which preserves the flexibility and user autonomy of EDC systems; and contemporarily, permits the creation of patients cohorts, as in EMR and EHR systems, in which to realize simultaneously different multicentric CTs in several medical fields. Keywords. Database, Clinical Trials, Electronic Data Capture, Electronic Medical Records, Patients Cohorts. Introduction Clinical Trials (CTs) play an increasingly important role in modern medicine and are an essential tool for the Evidence Based Medicine (EBM) approach [1, 2] . Clinical research generates a large amount of data that must be collected, processed and analyzed, often from centers which are in different places or countries. Consequently, Networked Clinical Research (NCR) and Clinical Data Management Systems (CDMSs) have become fundamental instruments for studies especially in the area of biomedicine and biotechnology. In general, trial data is collected at investigator sites with special forms, so called Case Report Forms (CRFs) which are then queried, cleaned, stored and analyzed by CDMSs. The collection of clinical data by means of electronic forms is called Electronic Data Capture (EDC) and the advantages of their use together with the internet for data management, is widely recognized [3, 4] . Recent surveys have shown a substantial heterogeneity in CDMSs in Europe, in fact there are many solutions but none of which are considered optimal [5-7] . In addition, in the academic community, where there is lack of human and financial resources, the open source solutions are widely employed like: (OpenClinica TM [8] , OpenCDMS TM [9] , PhOSCO TM [10] and REDCap [11] ). This type of solution, although low cost and suitable 1 Mauro.Giacomini@dist.unige.it Quality of Life through Quality of Information J. Mantas et al. (Eds.) IOS Press, 2012 © 2012 European Federation for Medical Informatics and IOS Press. All rights reserved. doi:10.3233/978-1-61499-101-4-554 554