"SMART Submit” is registered with the FDA, validated to FDA standards, and certified as fully HIPAA compliant. SMART Submit initially screens the images at upload to ensure the correct imaging procedure, the type of image capture device, and additional proprietary screens. It then checks file integrity as well as other known corruptions of DICOM images. When issues are uncovered, Clario will query the site regarding the issue and then advise the clinical site on how to resolve the immediate problem as well as identify or fix the underlying cause. SMART Submit has the technology to redact (de-identify/anonymize) DICOM tag meta data, including private tag data as required by the specific clinical trial, as well as pixelated (burned-in) identifiers when present.
Following Institutional Review Board (IRB) guidelines, GCPs, local regulatory requirements, and/or international data privacy standards, Clario’s stance is that it is the responsibility of the clinical site to de-identify images prior to submission. It is important that sites do not over anonymize the image data. Over anonymization can lead to blinding vital data within the DICOM tags, thus making the images corrupted beyond repair and unreadable. If the site cannot de-identify the images, Clario’s SMART Submit will perform this de-identification with a final quality check performed by the Clario Imaging Technologist during the quality control review of the received images
The following are key points to keep in mind while in the process of de-identification:
- Anonymize the subject’s name, patient ID, date of birth, institution, physician’s name/ID and medical record number. Replace this information with the subject’s study identification number, when possible.
- It is critical that sites do not edit the study date or technical information (e.g., slice location, kVP, echo time, etc.).
The table below lists important DICOM tags and how they should be processed during the on-site anonymization process prior to upload:
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