Reshaping clinical trial data collection process to use the advantages of the web-based electronic data collection

Abstract

In this paper some results of modeling web-based clinical trial electronic data collection process are presented. Clinical trial data collection is usually a paper-based process. Here we propose a new process of electronic data collection adjusted for the utilization of the web-based technology. Two models that we present here are the basis for the development of the electronic data collection software to support clinical trials. The first one defines use cases of the actors using the system. The second one is a model of the structure of the electronic Case Report Form (eCRF) document. Descriptions of these two models at a high level of abstraction are presented using the standard UML (Unified Modeling Language) version 2.0.