What statuses can kits have?

Have you ever wondered what each kit status really means for how you manage shipments in your study? Here's a list of every status a kit might have in Oracle Clinical One Platform and their descriptions.

Tip:

Depending on your role and the permissions assigned to it, you can see a kit’s changed status at either a site or depot, on the Study Inventory, Site Inventory, or Kit Reconciliation tabs, or in Subject History. Information about all kit statuses in your inventory can also be found in the Kit Inventory (Blinded) and Kit Inventory (Unblinded) reports in Oracle Clinical One Platform.

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Kit status	Description	How a kit reaches this status
Figure 8-1 Available	A kit is ready to be dispensed to subjects at a site, or ready to be shipped from a depot.	A kit's status is updated to Available as follows: Automatically: when kits are released to a depot for Testing mode, and when a site user marks a shipment as received. Manually: when a sponsor user releases kits to a depot for Production or Training mode.
Figure 8-2 Damaged	A kit was physically deteriorated at a site or depot. For example, a kit might have been damaged as a result of being dropped.	A site user or sponsor user marks the kit as Damaged.
Figure 8-3 Damaged by Subject	A kit was physically deteriorated after it was dispensed to the subject. In this case, the subject needs to return it to the site to be destroyed. Usually, if the kit is damaged by the subject, after returning it to the site, a new one is dispensed.	A site user marks the kit as Damaged by Subject.
Figure 8-4 Destroyed	A kit was destroyed during the kit reconciliation process. Most kits are destroyed after the subjects return them to site. Additionally, a kit is destroyed if it was damaged, it expired, or wasn’t dispensed to a subject at all.	Only Pending Destruction kits can be marked as Destroyed. Typically, before destruction, a Clinical Research Associate (CRA) verifies the kit and marks it as being ready for destruction. The next step depends on the location of the drug destruction facility: If a site is drug destruction capable, the site user destroys the kits and changes the status of the kits to Destroyed. If a site can't destroy drugs on site, either the CRA or someone at the site sends the kits that are ready for destruction to a depot that is a drug destruction facility. After the kit is destroyed, its status is updated to Destroyed.
Figure 8-5 Dispensed	A kit was dispensed to a subject during a dispensation visit.	A kit’s status automatically changes to Dispensed after a site user dispenses it to a subject.
Figure 8-6 Expired	The investigational product exceeded its expiration date.	A site or sponsor user marks a kit as Expired.
Figure 8-7 In Transit	A kit is being shipped from a depot to a site.	A shipment request was made by a site or sponsor user for that kit, and the ship date has been provided.
Figure 8-8 Lost by Subject	A kit went missing after being dispensed to a subject. Usually, if the kit is lost by a subject, a new one is dispensed to them.	A site user marks the kit as Lost by Subject.
Figure 8-9 Misallocated	A kit was dispensed in error. There are several reasons why a kit can be dispensed in error. For example, someone at the site might have given a subject a kit that was different from the kit that Oracle Clinical One Platform said to dispense, and the subject left the site with it; or someone at the site might have entered data in the wrong subject's visit and dispensed a kit.	A site user must dispense a replacement kit before marking the kit as Misallocated. If a site user marks a kit as Misallocated before dispensing a replacement kit, the site user won't be able to dispense a replacement kit. A site user manually updates a kit’s status to Misallocated.
Figure 8-10 Missing	A kit hasn't been dispensed yet and has gone missing from the site or depot.	A site user or sponsor user manually updates a kit’s status to Missing.
Figure 8-11 New	The kit has just been uploaded in Production mode, and it’s going to be manufactured and made ready for use.	The kit was created in Production mode.
Figure 8-12 Not Dispensed to Subject	A dispensed kit was never distributed. A subject might not receive a kit for various reasons. For example, they accidentally left the kit at the site after their visit, or the site user intentionally chose not to distribute the kit to them.	A site user marks the kit as Not Dispensed to Subject. A site user must dispense a replacement kit before marking the kit as Not Dispensed to Subject. If a site user marks a kit as Not Dispensed to Subject before dispensing a replacement kit, the site user won't be able to dispense a replacement kit.
Figure 8-13 Not in Use	A kit can’t be dispensed or shipped. Think of this status as an "emergency brake". Whenever users want to prevent a kit from being dispensed or shipped they mark it as Not in Use. For example, they would use this status if a kit needs to be moved from one depot to another.	A site user or sponsor user marked a kit as Not in Use. Kits included in a generated kit list in Production mode first appear in a study's inventory with a status of Not in Use.
Figure 8-14 Pending Destruction	A kit is ready to be destroyed.	Typically, the Clinical Research Associate (CRA) verifies the kit and then marks it as Pending Destruction. The user must provide a reason for the status update.
Figure 8-15 Pre-quarantined	A kit failed to comply with the shipment or storage requirements. For instance, it could have suffered a temperature or humidity excursion. After the kit is pre-quarantined, a clinical supply manager determines whether the kit can still be dispensed or not. If it can be dispensed, the kit changes its status to Available. If the kit can't be dispensed, the kit’s status is updated to Quarantined so that it isn’t considered part of the site's inventory anymore.	The sponsor user marks the kits as Pre-quarantined. A pre-quarantined kit is counted in a site’s inventory.
Figure 8-16 Quarantined	A kit failed to comply with the shipment or storage requirements, and it was damaged as a result. A Quarantined status marks the end of life for a kit. Quarantined kits can no longer be dispensed to subjects, and aren't counted in a site's inventory. Multiple quarantined kits from the same depot might be a sign of issues with a shipping procedure.	A clinical supply manager marks the kit as Quarantined.
Figure 8-17 Received for Destruction	The site user or Clinical Research Associate (CRA) has shipped the kit to a drug destruction depot and a depot user confirmed they received the kit for destruction at their facility. For instance, if a kit suffered some sort of irreversible damage, the site user might send it back to the depot facility to destroy it.	A depot user confirms a receipt per kit that they have received it at the depot.
Figure 8-18 Returned to Site	The subject returned the kit to the site. Subjects are required to bring any used and unused investigational products to their next dispensation visit. For instance, if the subject received three blisters of pills, and at his next dispensation visit they're left with three pills, they're required to return both the empty blisters and remaining pills to the site.	A site user changes the status of the kit to Returned to Site and indicates the number of returned and missing units.
Figure 8-19 Temporarily Unavailable	A kit is temporarily on hold and can’t be dispensed or shipped.	A site or sponsor user marks the kit as Temporarily Unavailable.