Understand dispensation exceptions
Learn more about setting dispensation exceptions for kits based on study requirements to adhere to study protocol and ensure patient safety.
As a clinical supply manager, it is your responsibility to dispense products for all scheduled dispensation based on protocol requirements while following study protocol and preserving patient safety. Dispensation exceptions allow you to set an exception for kits with the Do Not Dispense (DND) dispensation logic at both the country and site level.
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.
What sponsor users must know
- 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 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.
Parent topic: Define settings