H.1 Example Use-Case

Images are obtained for the purpose of comparing patients treated with placebo or the drug under test, then evaluated in a blinded manner by a team of radiologists at the Clinical Trial Coordinating Center (CTCC). The images are obtained at the clinical sites, collected by the CTCC, at which time their identifying attributes are removed and the Clinical Trial Identification (CTI) module is added. The de-identified images with the CTI information are then presented to the radiologists who make quantitative and/or qualitative assessments. The assessments, and in some cases the images, are returned to the sponsor for analysis, and later are contributed to the submission to the regulating authority.