Scenarios for Using OpenClinica in Academic Clinical Trials

Clinical Data Management Systems (CDMS) are used to electronically capture and store data about study participants in clinical trials. CDMS tend to be superior compared to paper-based data capture with respect to data quality, consistency, completeness and traceability. Nevertheless, their application is not default - especially in small-scale, academic clinical studies. While clinical researchers can choose from many different software vendors, the vast requirements of data management and the growing need for integration with other systems make it hard to select the most suitable one. Additionally, the financial and personnel costs for purchasing, deploying and maintaining a commercial solution can easily go beyond the limits of a research project's resources. The aim of this paper is to assess the suitability of the web-based open-source software OpenClinica for academic clinical trials with regards to functionalities required in a large research network.