Two Models Used as a Basis for Development of Electronic Data Collection Software to Support Clinical Trials

This paper is a presentation of some of the results of modeling web-based clinical trial electronic data collection process. 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 are presented at a high level of abstraction using the standard UML (unified modeling language) version 2.0.