Perform partial dispensation

Site users can now partially dispense investigational product to adapt to a kit shortage at a site.

To allow partial dispensation, this setting must be activated and details must be defined for the partial dispensation of a particular kit type. The partial dispensation option is available when multiple kits of the same type must be dispensed during a visit, as long as you have at least one kit available of each kit type that must be dispensed.

Consider the following when working with partial dispensation:

• For kits with calculated doses, data changes after a partial dispensation will not result in the recalculation of the dose.
• The Do Not Dispense (DND) days requirement considers the initial dispensation date only.
• When a partial dispensation occurs, the Dispensation notifications now include details related to it.

Details for clinical supply managers and other sponsor users

You can now activate partial dispensation from the Supply Settings page. Settings must be defined for each kit type that is allowed for partial dispensation, but it is not necessary for all kit types to be defined for partial dispensation or to have matching settings. Additionally, you can turn the partial dispensation setting on and off as required, globally and individually defined for a given kit type at a specific visit range.

For each kit type, you must specify a visit range during which partial dispensation is allowed. Any dispensation visit, scheduled or unscheduled, will allow partial dispensation for the given kit type, as long as it is within the defined visit range and regardless of whether there was a skipped visit or not.

To prevent subsequent shortage, predictive resupply strategies consider subjects with ongoing partial dispensation in the resupply orders.

Note:

Partial dispensation and dose holds cannot be simultaneously active in a study.

Details for site users

Site users are able to complete a visit when there are not enough kits available at the site to dispense.When performing a partial dispensation, you still need to follow the regular steps for dispensing the investigational product: complete the required forms, confirm the dispensation of kits, titrate, or dispense reusable kits, if applicable.

Details about performed partial dispensation display on the Subjects History pane. A partial dispensation must be completed before a subsequent dispensation visit, whether it is scheduled or unscheduled, otherwise visits will be left with incomplete dispensation. In this regard, the system warns you about pending partial dispensations whenever you attempt to dispense kits for a later visit. If the site still doesn't have enough kits upon the subject's return, you can perform another partial dispensation until the full amount of pending kits is available and the dispensation is complete. For titration studies, you can perform a later unscheduled titration to decrease the dose so that the subject doesn't need to come back for additional kits.

Already working in a live study?

As soon as this upgrade is complete, clinical supply managers can define partial dispensation settings. Once these settings are applied, site users will be able to perform partial dispensation and adjust to kit availability.

More information regarding partial dispensation will be featured in the Sponsor and CRO User Guide and the Site User Guide.