Understand how to manage kits from the same lot

In a study, you may have to ship or dispense kits from the same lot. Before choosing between managing kits from the same or multiple lots, you should understand the difference between these two types.

Managing kits from the same lot is optional. Enable the options Ship Kits from Same Lot to Site to transfer kits from the same lot from a central depot to a study site and Dispense from Same Lot to Subject at Site to assign and give kit(s) from the same lot to a subject at the site.

Dispensation flow

• When a blinded kit type has multiple blinded lots at the source depot, a sponsor user can configure Oracle Clinical One Platform to ship or dispense from the same lot. When multiple lots are available at a site, the dispensation algorithm will follow first-expiry-first-out (FEFO) strategy. When the subject dispensation is greater than the available kits in the FEFO lot, the system will chose from the next available lot and set the remaining kits in the FEFO lot as Not in Use.
• If Blinded Lots are used in the study, selected blinded kits may come from different Manufacturing Lots, as long as they belong to the same Blinded Lot. If Blinded Lots are not used, all selected blinded kits must come from the same Manufacturing Lot.
• If a kit needs replacement, the new kit will always come from the same lot as defined at the time of the original dispensation.
• In cases of active partial dispensation, kits dispensed at initiation are from the same lot. When the remaining kits are dispensed later, they must also be from a single lot, which may be different from the original dispensed lot.
• For studies with forced randomization enabled, all dispensed kits will come from the same lot.
• When a subject is removed from a dose hold, the kit dispensed will be from the same lot.

Shipment flow

• Manual shipment requests will fail if you attempt to select kits from multiple lots for blinded kit types, ensuring lot consistency for blinded treatments.
• If a single shipment request results in multiple shipments (for example, different shipment addresses), all blinded kits across those shipments will share the same blinded lot number.
• If the selected lot does not have enough kits available for manual shipments, the system will provide a warning to help you adjust your dispensing plan before proceeding.
• When creating a manual shipment, you can now include up to 999 kits in a single shipment.

For example, you need to dispense five kits to a subject, but only two kits at FEFO lot 1 (lowest expiring lot) are available at your site. After check-in, your inventory shows seven kits, two with low expiry, five with high expiry. When Dispense from Same Lot to Subject at Site is set to Yes, the system will select the five available kits for the subject. The kits from the FEFO lot will be set to Not in Use.