This Annex was formerly located in Annex O of PS 3.3 in the 2003 and earlier revisions of the standard.
The Clinical Trial Identification modules are optional. As such, there are several points in the workflow of clinical trial data at which the Clinical Trial Identification attributes may be added to the data. At the Clinical Trial Site, the attributes may be added at the scanner, a PACS system, a site workstation, or a workstation provided to the site by a Clinical Trial Coordinating Center. If not added at the site, the Clinical Trial Identification attributes may be added to the data after receipt by the Clinical Trial Coordinating Center. The addition of clinical trial attributes does not itself require changes to the SOP Instance UID. However, the clinical trial protocol or the process of de-identification may require such a change.
Figure H-1 – Workflow Diagram for Clinical Trials
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.