Clinical trial information is added as a separate module to each DICOM image object. Clinical trial information can be added as optional attributes to each image to avoid this information being captured in a proprietary manner.

This clinical trial identification (CTI) module allows the identification of images and related data acquired for subjects involved in clinical trials. They are intended for data submission and re-transmission in both national and international regulatory trials, as well as multi-institutional cooperative-group investigations.

Descriptive information is added that is unique within the context of a given clinical trial. The additional descriptive parameters include the clinical trial sponsor, clinical trial protocol, clinical trial site, clinical trial subject identification number, clinical trial subject reading number, clinical trial time point and clinical trial coordinating center.

The clinical trial identification modules alone do not remove personal identification or otherwise specify which attributes of DICOM information objects should be removed or replaced to assure patient confidentiality. This decision should be made after considering the regulations of each country and/or its sub-region. Instead, the module provides an alternative means for identifying DICOM information objects when personal identification is absent or hidden.

There are several points in the workflow of clinical trial data at which the CTI 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 (CTCC). If not added at the site, the clinical trial identification attributes may be added to the data after receipt by the CTCC.




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