Implementing a Web-Based Architecture for DICOM Data Capture in Clinical Trials

Medical imaging plays an important role in clinical trials providing qualitative and quantitative findings. Patient's data in studies is captured in electronic case report forms (eCRFs) instead of paper-based CRFs, which are provided by electronic data capture systems (EDCS). However, EDCS insufficiently support integration of image data into patient's eCRF. Neither interfacing with picture archiving and communication systems (PACS), nor managing of digital imaging and communications in medicine (DICOM) data in eCRFs is possible. Hence, manual detours for image data in study's data capture workflow increase error-proneness, latency, and costs. In this work, a completely web-based system architecture is implemented interconnecting EDCS and PACS. Our approach utilizes the open source projects OpenClinica, DCM4CHEE, and Weasis as EDCS, PACS, and DICOM web viewer, respectively. In the optimized workflow, user interaction completely takes place in the eCRF. DICOM data storage and retrieval is performed by middleware components hidden from the user, ensuring data consistency and security by identifier synchronization and de-identification, respectively. This shortens paths for image data capture in the workflow, reduces errors, and saves time and costs. Beside this, valuable data for further research is centrally and anonymously stored in a research PACS.