Digital Imaging and Electronic Data Capture in Multi-Center Clinical Trials.

While medical image data is managed in picture archiving and communication systems (PACS) via the digital imaging and communications in medicine (DICOM) protocol, electronic data capture systems (EDCS) in clinical trials lack PACS interfacing. This complicates the trial workflow and increases errors, time, and costs. In this work, four system architectures of image integration for multi-center trials are analyzed with respect to data, function, visual, and context integration levels. We propose an open source-based architecture composed of OpenClinica, DCM4CHE, and Weasis for EDCS, PACS, and Viewer, respectively.