Design of an electronic upload and reporting system aimed at corelab tasks and responsibilities in multi-center clinical trials

In multicenter clinical trials images are interpreted and analyzed by an imaging core laboratory (ICL) to generate consistent results with the least possible variance. Currently, transfer of the images can be achieved via postal services (physical media) or web-based via upload portals that merely act as a digital substitute for traditional logistics. Image verification before and data entry after analysis is performed manually with possible introduction of human errors. We describe the design of a software system that facilitates general ICL logistics, such as digital transfer of images, automated DICOM data verification, semi-automated image quality assessment, reporting and automated database generation in multicenter clinical trials. All steps in the workflow are guided by and validated against the trial design. Validation failure(s) at any point are reported instantaneously to all persons concerned, consequently increasing efficiency and possibly reducing trial costs.