Define dispensation rollback

Sponsor users can now allow sites to perform dispensation roll back to clear a dispensation event and correct errors or reschedule a subject visit.

Before you work with this feature

The newly introduced permissions allow users to configure or view the appropriate rollback settings and receive new notifications:

Permission name	Details
Manage Rollback Dispensation Settings	This permission allows sponsor users to define dispensation rollback settings for a study.
View Rollback Dispensation Settings	This permission allows sponsor users to view the dispensation rollback settings for a study.
Dispensation Rollback	This permission allows sponsor and site users to rollback a visit's dispensation.
Receive the Dispensation Rollback Unblinded Pharmacist Kits Notification	This permission allows sponsor and site users to receive the new Dispensation Rollback Unblinded Pharmacist Kits notification.
Receive the Dispensation Rollback Notification	This permissions allows sponsor and site users to receive the new Dispensation Rollback notification.

More information can be found in the Add Users Guide and Notifications Guide after the upgrade.

Details for study managers

When it comes to creating rollback events as a study manager, here's what's new for you:

• On the Study Settings page, the new Rollback Settings section provides you with the option to add a Rollback event, and define the countries and types of visits you would like this rollback event to apply to.
• The Dispense button becomes available for all rolled back dispensation visits chosen by a site user, including Unscheduled visits. If an Unscheduled visit dispensation rollback is not configured in the study's settings, the previous visit dispensation is not able to be rolled back until this is configured and the Unscheduled visit dispensation has been rolled back.
• You cannot apply dispensation rollback to Randomization or Re-randomization visits.

Details for site users

• On the Subjects page, in the Manage Subjects drop-down, the new Rollback last dispensation option is available. This option dynamically appears in the drop-down for a selected subject when your study has dispensation rollback settings defined for your site's country and you role is assigned associated permissions to dispensation rollback.
• Once Rollback last dispensation is selected for a subject, the Rollback Last Dispensation dialog prompts you to choose a reason for rollback.

• After a visit's dispensation has been rolled back, the Dispense button becomes available and must be completed in the order of the visit schedule.

  For example, Visit 3's dispensation is rolled back, Visit 2's dispensation is rolled back, then Visit 1's. You must dispense for Visit 1 before you can move on to Visit 2's.

  The Dispense button appears for all rolled back dispensation visits, however, if you do not fulfill the dispensation, skipping or placing a dose hold on the previous visit's dispensation results in the following error:

  The previous visit has not been completed. Please complete the visits according to the order in the visit schedule.
• Only one subject can be rolled back at a time. The Rollback last dispensation option in the Manage Subjects drop-down is disabled if more than one subject is selected in the list.
• You cannot rollback dispensation for a subject that is either locked or frozen.
• Dispensation from the previous site does not carry over to the next site for transferred subjects.

  Note:

  Dispensation rollback cannot be configured after subject transfer, but is available once visits are created for the current site.

More information can be found in the Site Users Guide after the upgrade.

Impact on reports, extracts, archives, and datasets

Report or dataset	Type of change	Description
Kit Chain of Custody (Unblinded) report	Modified column data	The Status column in this report displays as one of the following: Not Dispensed to Subject Available Damaged
Subject Visits (Unblinded and Blinded) reports	Modified column data	The Kit Number / Lot Number column in these reports displays N/A for kits that were rolled back after being dispensed to a subject. Rollback visits do not appear on these reports.
Study Settings report	Modified column data and new report tab	The Rollback Settings tab has been added to the Study Settings report, indicating the rollback visit information and defined study settings.
Subject Events report	Modified column data	The Event Type column indicates rollback dispensation events. Kits a part of rolled back dispensation are displayed in the Dispensation Kit / Lot Number column.
Blinded Subject Event dataset Unblinded Subject Event dataset Blinded Kits dataset Unblinded Kits dataset	Modified column data	The chosen Reason for Change when performing rollback dispensation is included in these datasets.

More information can be found in the Reporting Guide and Analytics User Guide after the upgrade.

Impact on integrations

If your study works with integrated systems, see Dispensation rollback events are supported by outbound integrations.

Already working in a live study?

Once the upgrade completes, you can configure dispensation rollback for your new and existing studies. Once configured in your study's settings, sites can perform dispensation rollback for the latest dispensation visit only.