Uploading Imaging Exams

Imaging Enablement: In the current release, the Vault EDC Imaging module is only available to specific early adopter customers. Contact your Veeva Services representative for details.

Vault EDC Imaging allows Imaging data gathered in the course of your Study to be shared across all CDMS modules. Site users can upload exams through the Imaging Exam study object, which connects the exam with the associated Subject. Users with imaging permissions can view uploaded Imaging Exams in the Sites, Imaging, or Review tabs. Users can also download Imaging Exams through the Imaging tab. Imaging information is retained in the same system as the rest of the study data which offers benefits such as reducing the need for data reconciliation, making sponsor oversight more efficient, and optimizing workflows.

Prerequisites

Required Permissions

Users with the following study roles can perform the actions described below by default: CDMS Clinical Research Coordinator, CDMS Principal Investigator, and CDMS Sub Investigator. If your organization uses custom roles, your Study Role must grant the following permissions:

Type Permission Label Controls
Standard Tab Data Entry Tab

Ability to access the Data Entry tab
Functional Permission Data Entry

Ability to enter study execution data
Functional Permission Upload Imaging Exam

Ability to upload Imaging Exams

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Uploading Imaging Exams

There are three stages to the Imaging Exam upload workflow in Data Entry: exam selection, exam review, and exam upload. You must remain logged in to Vault EDC and within the Data Entry tab while exam upload is in progress.

Selecting Imaging Exams

In the first step of the exam upload process, you select the exam that you want to upload. The system performs validations on the selected exam to check the following:

  • The exam is unzipped and in DICOM® format.
  • The exam does not exceed the maximum size of 50MB per file or 4GB in total.
  • Only one exam is selected for upload.
  • The selected exam does not contain duplicate data.
  • The DICOM® metadata that is used to enforce the integrity, accuracy and consistency of the exam is present & consistent.

If the exam does not pass all the system validations, the exam upload fails and an error message is displayed. You must resolve any errors outside of Vault EDC before proceeding with the exam upload. Learn more about Imaging Exam Upload validations.

After selecting the exam, you must review the exam to verify that it does not contain protected health information (PHI) or personally identifiable information (PII).

To select an imaging exam:

  1. Navigate to the Form that contains the Imaging Exam Item Group you want to add an exam to, and click Upload Exam. Upload Exam button

  2. In the Upload Exam window, drag and drop the exam to the Drag and drop exam here area, or select the exam files or folder to upload. The system automatically validates the exam.
  3. When the exam passes validation, click Review Exam. The exam viewer is displayed for you to review the exam. Review Exam button

Reviewing Exams

When an exam is uploaded, the Vault EDC Imaging module de-identifies file names and metadata that contains PHI/PII in accordance with the Basic Application-Level Confidentiality Profile of the DICOM® standard. When an exam is uploaded to Vault EDC, DICOM® tags that are not retained by the system are replaced with dummy values and Private Tags are removed entirely.

Vault EDC Imaging’s de-identification process is system defined and cannot be customized.

Reviewing an Imaging Exam for PHI/PII: We recommend that you thoroughly review the complete exam to verify that images and metadata do not contain any PHI/PII. Follow the Imaging Exam review guidelines for the study when conducting exam review.

To review an imaging exam:

  1. On the Upload Exam screen, expand the series dropdowns under the Exam Browser panel to view the files contained in each series. The names of unread series are bolded and marked with an orange circle (fas fa-circle but make it orange).
  2. Click on the file names of the images in the series, or use the left () and right () arrows on the upper left of the image to move forward and backward through the images in the series.
  3. Optional: You can pan (), zoom (), and maximize (), and reset () the panned or zoomed view of the image.
  4. Optional: To return to normal view when the image is maximized, click Return in the upper left corner of the screen.

  5. Optional: Select Show De-identified Tags to display the DICOM tags that are automatically de-identified by the system. Show De-identified Tags button

  6. Optional: You can remove images that are not relevant to the exam by hovering over the series folder or image file name in the Exam Browser panel and clicking the Delete icon ().

  7. Once you have thoroughly reviewed and verified that the exam images and metadata do not contain PHI/PII, click Verify Exam. Verify Exam button

  8. In the Verify Absence of PHI/PII dialog, type VERIFY and click Verify and Upload. The system begins uploading the exam to the form. Verify and Upload dialog

Imaging Exam Deidentification: Vault EDC does not support de-identification of images that have PHI or PII burned into their pixel data. If you identify images containing PHI/PII, do not upload the images and contact your imaging administrator to have the pixel data de-identified.

The system begins uploading the exam to the form. You are redirected to the form containing the Imaging Exam, and an upload drawer that tracks the progress of the exam upload is displayed. You can continue performing data entry while the exam upload is in progress, but you cannot submit the form until the exam upload has completed. Do not log out of Vault EDC or navigate away from the Data Entry tab or the upload will be canceled.

Canceling an Exam Upload

To cancel an exam upload that is in progress:

  1. In the exam upload drawer, click the cancel icon () next to the exam upload.
  2. In the Cancel Exam Upload dialog, click Cancel Upload. The exam upload is canceled.

Deleting an Uploaded Exam

To delete an uploaded exam:

  1. Navigate to the form containing the exam you want to delete.
  2. Hover over the Imaging Exam item to display the Actions menu.
  3. Click Delete Exam.
  4. In the Delete Exam dialog, click Delete.

Imaging Best Practices

To ensure that the imaging exam uploads correctly, we recommend that you follow these best practices:

  • Avoid having many browsers, computer programs, or tabs running on your computer while uploading imaging exams.
  • Ensure that your internet connection is strong. We recommend that you use an Ethernet (wired) connection when uploading imaging exams.
  • Ensure that your computer has enough free storage space to temporarily process the exam. The required storage space is equal to the exam size, for example, a 1GB imaging exam would require at least 1GB of storage space.

Imaging Exam Upload Validation Errors

You must resolve all errors outside Vault EDC before the system will allow you to upload an exam. Errors may be displayed in the Drag and drop exam here area or under the Failed tab. See the Actions column in the table below for possible ways to resolve each error.

DICOM® Related Errors: In most cases, DICOM-related errors must be resolved by your imaging administrator. If you encounter a DICOM-related error, you must contact your imaging administrator to resolve the issues with the DICOM® file.

Error message Explanation Actions
Drag and Drop Area Errors
Cannot be read. Ensure file is unzipped and in DICOM® format. The selected file is either not a DICOM® file or the file is compressed (zipped). Ensure the file is unzipped and in DICOM® format.
Exam failed to process. Size cannot exceed 4 GB. The complete exam exceeds the limit of 4 GB. Contact your sponsor to discuss how to transmit the exam. Vault EDC Imaging does not support upload of imaging exams exceeding 4GB.
Exam failed to process. You are running low on disk space. Your browser has thrown a low disk space error. Your computer does not have enough storage space to process the exam for upload. Clear unneeded files from your hard drive to make more disk space available.
Exam failed to process. You cannot select more than one exam for upload. The folder you selected contains more than one exam. Select only one exam from the folder for upload.
Exam failed to process. The exam must have an uncompressed Transfer Syntax. DICOM-related error: The Transfer Syntax UID (0002,0010) contains an unsupported value. Contact your imaging administrator. Vault EDC Imaging supports the following Transfer Syntax UID values:
  • Explicit VR Little Endian: 1.2.840.10008.1.​2.​1
  • Implicit VR Little Endian: 1.2.840.10008.1.​2
Failed Tab Errors
File size exceeds limit of 50 MB An uploaded file exceeds the limit of 50 MB. Contact your imaging administrator. Vault EDC Imaging does not support upload of individual files exceeding 50MB.
Cannot be read. <tag name><code> has an unsupported or missing value DICOM-related error: The specified DICOM® tag is missing or does not contain a value. Contact your imaging administrator and share the error message you received. Your imaging administrator must resolve the missing DICOM® tag issue before you can upload the exam.
<tag name><code> requires a value DICOM-related error: The DICOM® tag specified in the error message either does not exist, or exists but with a null value. Contact your imaging administrator and share the error message you received. Your imaging administrator must resolve the missing DICOM® tag issue before you can upload the exam.
File is a duplicate of <file name> DICOM-related error: When the system detects duplicate files in your exam upload, the system only retains the first file and fails each duplicate file. If possible, you can attempt to remove the duplicate files. If you cannot remove the files, contact your Imaging administrator to remove the duplicate files from the imaging exam.
Inconsistency detected in <tag name><code>. This value differs across all exam files DICOM-related error: The specified DICOM® tags are not identical across all files in the exam. Contact your imaging administrator and share the error message you received. Your imaging administrator must resolve the inconsistent DICOM® tag issue before you can upload the exam.
Inconsistency detected in <tag name><code>. This value differs across the files in this series DICOM-related error: The specified DICOM® tags are not identical across all images within a series. Contact your imaging administrator and share the error message you received. Your imaging administrator must resolve the inconsistent DICOM® tag issue before you can upload the exam.

Validated DICOM® Tags

The following tags are validated by the system when a DICOM® exam is uploaded:

  • Study Instance UID (0020,000D)
  • Series Instance UID (0020,000E)
  • SOP Instance UID (0008,0018)
  • Modality (0008,0060)
  • Clinical Trial Sponsor Name (0012,0010)
  • Clinical Trial Protocol ID (0012,0020)
  • Clinical Trial Site ID (0012,0030)
  • Clinical Trial Subject ID (0012,0040)
  • Clinical Trial Subject Reading (0012,0042)
  • Study Date (0008,0020)
  • Accession Number (0008,0050)
  • Transfer Syntax UID (0002,0010)

Uploading Imaging Exams for Site Users

Last Updated: 24R3

This video provides instructions on how to upload imaging exams as a site user.