1 Kit status descriptions

Learn more about the different icons that represent kit statuses.

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 Inventory and Kit Reconciliation tabs, or in Subject History. Information about all kit statuses in your inventory can also be found in the Kit Inventory (Blinded) report and Kit Inventory (Unblinded) report in Oracle Clinical One Platform.

Status icon	What it means	How a kit reaches this status
	Available The 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: Automatically: when kits are created or uploaded. Manually: when a sponsor user releases kits to a depot for Production or Training mode.
	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.
	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 during the kit reconciliation process. If a kit replacement occurs and the user marks the kit as Damaged, the status of the kit will change to Damaged by Subject.
	Destroyed The 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.	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. Only Pending Destruction kits can be marked as Destroyed.
	Dispensed The kit was dispensed to a subject during a dispensation visit.	The kit’s status automatically changes to Dispensed after a site user dispenses it to a subject.
	Expired The investigational product exceeded its expiration date.	The system automatically updates the status of the kit to Expired when it exceeds its expiration date.
	In Transit The 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.
	Lost by Subject The 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 during the kit reconciliation process. If a kit replacement occurs and the user marks the kit as Lost, the status of the kit will change to Lost by Subject.
	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 manually updates a kit’s status to Misallocated. 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.
	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.
	New The kit has just been uploaded and is going to be manufactured and made ready for use.	A site user or sponsor user manually updates a kit's status to New.
	Not Dispensed to Subject The 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.
	Not in Use The kit can’t be dispensed or shipped, or it has just been uploaded to production. 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.	The site user or sponsor user marked the kit as Not in Use or has just been uploaded to Production.
	Pending Destruction The 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.
	Pre-Quarantined The 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.
	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.
	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.
	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.
	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.