Learn more about setting dispensation (DND) exceptions for kits based on study requirements. Use DND exceptions to adhere to study protocol and ensure patient safety.

As a Clinical Supply Manager(CSM), it is your responsibility to dispense products for all scheduled dispensation based on protocol requirements while 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.

While study designers can configure the Do Not Dispense (DND) Days in a study's visit schedule, a sponsor user (typically a CSM) can configure DND exceptions for a site or country to better control dispensation during the study conduct period. Exceptions can be made for all visits where dispensation occurs. 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.

The DND logic then considers the limit or exceptions for a subject's country or site at the time of dispensation. This is also applied when the subject completes a partial dispensation or when removing the subject from a dose hold visit.

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.