Title: A flexible framework for managing temporal clinical trial data

Authors: Michael Souillard, Carine Souveyet, Costas Vassilakis, Anya Sotiropoulou

Addresses: Centre Recherche Informatique, Universite Paris I Sorbonne, 90 rue Tolbiac, 75013 Paris, France. ' Centre Recherche Informatique, Universite Paris I Sorbonne, 90 rue Tolbiac, 75013 Paris, France. ' Department of Computer Science and Technology, University of Peloponnese, Terma Karaiskaki 22100, Tripolis, Greece. ' Department of Computer Science and Technology, University of Peloponnese, Terma Karaiskaki 22100, Tripolis, Greece

Abstract: Clinical trials are processes that produce large volumes of complex data, with inherent temporal requirements, since the state of patients evolves during the trials, and the data acquisition phase itself needs to be monitored. Additionally, since the requirements for all clinical trials have a significant common portion, it is desirable to capture these common requirements in a generalised framework, which will be instantiated for each specific trial by supplementing the trial-specific requirements. In this paper, we present an integral approach to clinical trial management, using a temporal object-oriented methodology to capture and model the requirements, a temporal OODBMS for data storage and a generalised template application, through which trial-specific applications may be generated.

Keywords: clinical trials; e-healthcare; electronic healthcare; medical applications; temporal data; clinical studies; trial data; object-oriented methodology; data storage; medical informatics.

DOI: 10.1504/IJEH.2005.006691

International Journal of Electronic Healthcare, 2005 Vol.1 No.4, pp.453 - 463

Published online: 01 Apr 2005 *

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