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 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) and Kit Inventory (Unblinded) reports in Oracle Clinical One PlatformAvailable 
What it means: The kit is ready to be dispensed to subjects at a site, or ready to be shipped from a depot.
- 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.
Damaged
What it means: A kit was physically deteriorated at a site or depot. For example, a kit might have been damaged as a result of being dropped.
How a kit reaches this status: A site user or sponsor user marks the kit as Damaged.
Damaged by Subject 
What it means: 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.
How a kit reaches this status: A site user marks the kit as Damaged by Subject.
Destroyed
What it means: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.
- 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.
Note:
Only Pending Destruction kits can be marked as Destroyed.Dispensed
What it means: The kit was dispensed to a subject during a dispensation visit.
How a kit reaches this status: The kit’s status automatically changes to Dispensed after a site user dispenses it to a subject.
Expired
What it means: The investigational product exceeded its expiration date.
How a kit reaches this status:A site or sponsor user marks it as Expired.
In Transit
What it means: The kit is being shipped from a depot to a site.
How a kit reaches this status: A shipment request was made by a site or sponsor user for that kit, and the ship date has been provided.
Lost by Subject
What it means: 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.
How a kit reaches this status: A site user marks the kit as Lost by Subject.
Misallocated
What it means: 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.
How a kit reaches this status: A site user manually updates a kit’s status to Misallocated.
Note:
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
What it means: A kit hasn't been dispensed yet and has gone missing from the site or depot.
How a kit reaches this status: A site user or sponsor user manually updates a kit’s status to Missing.
New
What it means: The kit has just been uploaded in Production mode, and it’s going to be manufactured and made ready for use.
How a kit reaches this status: The kit was created in Production mode.
Not Dispensed to Subject 
What it means: 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.
How a kit reaches this status: A site user marks the kit as Not Dispensed to Subject.
Note:
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
What it means: The 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.
How a kit reaches this status: The site user or sponsor user marked the kit as Not in use.
Pending Destruction 
What it means: The kit is ready to be destroyed.
How a kit reaches this status: 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 
What it means: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.
How a kit reaches this status: The sponsor user marks the kits as Pre-quarantined.
Note:
A pre-quarantined kit is counted in a site’s inventory.Quarantined
What it means: 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.
How a kit reaches this status: A clinical supply manager marks the kit as Quarantined.
Received for Destruction 
What it means: 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.
How a kit reaches this status: A depot user confirms a receipt per kit that they have received it at the depot.
Returned to Site
What it means: 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.
How a kit reaches this status: A site user changes the status of the kit to Returned to Site and indicates the number of returned and missing units.
Temporarily unavailable 
What it means: A kit is temporarily on hold and can’t be dispensed or shipped.
How a kit reaches this status: A site or sponsor user marks the kit as Temporarily Unavailable.
Parent topic: Kits and dispensation FAQs