Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials

摘要

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. Several IT systems are used to support clinical trial conduction but they are usually disconnected from the hospital information systems (HIS). Therefore, the principle investigator of a controlled clinical trial might not be informed when a serious adverse event (SAE) or a suspected unexpected serious adverse reaction (SUSAR) occur. To ensure information exchange between the HIS and the clinical trial management system (CTMS), we model an appropriate IT infrastructure supporting SAE / SUSAR identification. Furthermore, the tool is designed to support and assist the trial team in timely and accurate reporting of such events.