A fl exible framework for managing temporal clinical trial data

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.