Design and implementation of reading center software for multi-center clinical trials

In clinical trials, advanced technical examinations generate huge amounts of complex data which can then be used to evaluate safety, efficiency, and efficacy of health interventions. Those data are submitted to reading centers that specialize in analyzing particular examination types. Though they possess many advantages, reading centers also introduce an additional aspect of complexity and increased effort to clinical trials that then needs to be managed. In this thesis, a software solution called RCSW is presented. RCSW is used for data and workflow management in reading centers in multi-center clinical trials. RCSW is generic software which can be easily customized for use in individual reading centers. It allows for the implementation of arbitrary complex analysis processes based on a sophisticated workflow framework. Access to RCSW is possible through a web application. Furthermore, a web service exists which can be used to link external software to RCSW. Regulatory authorities set up a multitude of requirements and recommendations concerning software used in clinical trials. Relevant regulatory documents and resulting requirements for RCSW are presented. Subsequently, it is shown how RCSW complies with these requirements. Finally, application of RCSW at the ERG Reading Center at the University of Tübingen for assessment of electroretinographic data is introduced. This reading center was the primary incentive for the development of RCSW and is used as a proof-of-concept showcase for customization. The specifically developed components for examination types and the employed reading process are presented. Further, it is described how external analysis software uses the web service to directly interact with RCSW.