Bulk update randomization statuses by treatment arm

Sponsor users can now update the status of multiple randomization numbers at once for a selected treatment arm, helping manage dosing arms more efficiently during study changes and reducing manual updates.

Details for study teams

When managing a randomization list, here's what's new:

• On the Randomization tab, you can now filter randomization numbers by Treatment Arm.
• After filtering, you can select multiple randomization numbers and update their status in a single action.
• You can bulk update the following statuses:
  1. Available to
  2. Not Approved or
  3. Not Released
  4. Not Approved or
  5. Not Released to
  6. Available
• If your selection includes randomization numbers that can't be updated as part of the same bulk action, you'll receive a message identifying the issue.
• Bulk status updates run in the background, allowing you to continue working while the update completes.
• When a bulk update is submitted, an in-application message confirms that an email notification will be sent when processing is complete.
• All bulk status updates are captured in the audit trail.

Impact on notifications

New notifications are available for bulk randomization status updates:

Notification type	Description
Randomization Status Update Requested	Sent when a bulk update is submitted.
Randomization Status Update Completed	Sent when a bulk update finishes successfully.
Randomization Status Update Failed	Sent if the update cannot be completed.

These notifications include details such as the randomization list, updated status, number of affected randomization numbers, date performed, and the user who initiated the update.

Impact on reports

Randomization Reports (Blinded and Unblinded) now reflect updates made through bulk randomization status changes.

More information about the new bulk update randomization and available data elements in the Sponsor and CRO User Guide, Notifications and Permissions Guide, and Reporting Guide, after the release assessment environment upgrade.