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Record an Unblind and Emergency Unblind Event in Mentor EDC

Emergency Unblind

**Refer to Record an Unmask and Emergency Unmask Event as needed.

  1. Click on the Participant folder or any form/folder for the Participant.
  2. Click the tools button (wrench icon) to open the menu then click the Emergency Unblind button.
  3. The dialog box opens and detail for the selected Subject ID displays.
  4. Enter a Reason for Unblind in the dialog box.
  5. Click the OK button.
  6. A dialog box with summary information displays.
  7. Click the Close button.
    EDC-EmergencyUnblind_519

 

Record an Unblind Event in EDC

  • When the “Unblinding Subclass” feature is active in your environment, and a subject is unblinded, the system will automatically create an iteration of the form to record the date and reason for the unblinding event (UBLINDDT_EDC and UNBLINDREASON_EDC fields are populated in database).
  • Additionally, a record is automatically created in the History tab.
  • Alerts can be configured to be triggered when an Unblind Event occurs.
  • Unblind Event data may be exported.
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