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Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials
1Department of Medical Informatics, Uniklinik RWTH Aachen, Aachen, Germany.
Abstract:
Serious adverse events (AE) or reactions (AR) may occur in clinical trials and require particularly regulated reporting. Manual management is inefficient and ineffective. Based on a description of regulations, we have developed a data model with class-, state-, use-case- and activity diagrams, which can be used for automatic code generation of an assisting software tool for AE / AR data management.
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