Manage kits from the same lot

Sponsor users can now manage kits from the same lot for sites and subjects.

Details for sponsor users

Sponsor users now see two new fields on the Supply Settings tab under Shipment Settings:

• Ship Kits from Same Lot to Site: Ensures that all kits shipped from the depot to a site are from the same lot, updating site inventory without assigning kits to subjects.
• Dispense from Same Lot to Subject at Site: Assigns and dispenses kits to a subject at the site, ensuring all kits come from the same lot. Kits are removed from site inventory and linked to the subject.

Depot-to-site shipment

• In a depot-to-site shipment, the system searches until it successfully locates lots according to expiry dates (first-expiry-first-out) and sufficient kits from the same lot to send them in one shipment. The shipment fails if there are not enough kits in the same lot.

• The system displays a warning if the selected lot does not contain enough kits, so you can adjust your plan before proceeding.

• For blinded kits, the system ships all kits from the same blinded lot (across manufacturing lots) or the same manufacturing lot if the study does not use blinded lots. For unblinded kits, you can ship kits from any lot.

Dispensation at sites

• The system uses first-expiry-first-outame (FEFO) and checks for enough kits from the same lot before dispensing. The system prevents dispensing if it cannot find enough kits in a single lot.
• When dispensation is completed at a site, all blinded kits come from the same lot. If the study uses blinded lots, the selected blinded kits may come from different manufacturing lots, but they belong to the same blinded lot. If the study does not use blinded lots, the selected blinded kits all come from the same manufacturing lot. When you switch to a new lot, the system disables kits from the previous lot.
• When you replace a kit, the system provides a replacement from the same lot as the original dispensation.
• If your study has forced randomization active, the dispensed kits come from the same lot.
• For partial dispensation, the system ensures the initial and subsequent kits each come from the same lot, but they do not need to match each other. If a single shipment request includes multiple shipments to complete, such as when one request involves multiple shipping addresses, the blinded kits in all the shipments have the same blinded lot number.
• When a subject is removed from a dose hold, the dispensed kit comes from the same lot.
• Manual shipments fail if you select multiple lots for blinded kit types.
• During randomization, the system assigns kits from the same lot when all are available.
• If a shipment request results in multiple shipments, for example, when the request includes several shipping addresses, all blinded kits in those shipments use the same blinded lot number.
• You can include up to 999 kits in a manual shipment request.

• Note:

  If the Dispense reusable kits option is enabled, the lot is not rechecked during the dispensing process.

More information and step-by-step instructions about configuring locally sourced kits can be found in the Sponsor and CRO User Guide after the assessment environment upgrade.

Impact on reports, extracts, archives, or datasets

These reports now include details of the new kit management options you select:

Report	Type of change	Description of enhancements
Study Settings Report	New columns	Ship Kits from Same Lot to Site and Dispense from Same Lot to Subject at Site columns in the Supplies Settings section display the status (enabled/disabled) for new lot management options.
Study Design report	New columns	Ship Kits from Same Lot to Site and Dispense from Same Lot to Subject at Site columns display the status (enabled/disabled) for new lot management options.

You can find additional information in the Reporting Guide after the assessment environment upgrade.

Already working in a live study?

As soon as the upgrade for this release completes, you can begin shipping and dispensing kits from the same lot in existing studies.