Set exceptions to kits with the Do Not Dispense dispensation logic

Additional options are available to sponsor users, allowing them to control kit dispensation based on protocol requirements and to ensure patient safety.

Clinical supply managers now have the ability to set an exception for kits with the Do Not Dispense (DND) dispensation logic at both the country and site level to adhere to protocol requirements and preserve patient safety.

This feature supports sponsor users in scenarios such as a country or a site that requires a longer expiration timeframe for distributing the investigational product to subjects. Similarly, this can be helpful in emergency situations when there is a shortage in supply at the site and an override of the initial distribution setting is necessary.

Details for sponsor users

When it comes to configuring dispensation schedules for kits, here's what has been enhanced in your workflow:

• You must be assigned the View Dispensation Exceptions permission in order to view dispensation exceptions that have been created.
• You must be assigned the Create and Manage Dispensation Exceptions permission in order to add, edit, copy, and delete DND dispensation logic exceptions.
• Study designers can still configure the DND (Days) in a study's visit schedule, while a clinical supply manager (or a sponsor user) can configure exceptions to the DND dispensation during the study conduct period, as well.

  For more information on specifying DND dispensation in study design, see Define the dispensation schedule.

• Exceptions to the DND logic are created on the Study Supplies page and can be defined by country, which are included at the time of depot or site creation. Exceptions can be further defined by site within the country, and updated at the site or country level by visit.
• Exceptions can be made for all visits where dispensation occurs.
• The DND logic considers the limit or exceptions at the time of dispensation for a subject's country or site when the subject completes a partial dispensation or removing the subject from a dose hold visit.
• When removing an exception from a site, the site defaults to the country's DND settings. If you remove an exception from a country, the country returns to the study design's default DND settings.

More information and step-by-step instructions can be found in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Impact on reports

The Study Design report now includes exceptions set for kits with the DND dispensation logic.