Distribute non-serialized inventory

Clinical supply managers can now provide sites with the ability to distribute non-serialized inventory to subjects and define a resupply process to ensure product availability when needed.

The use of non-serialized inventory can be helpful in numerous scenarios, especially in studies with a large number of subjects that require a larger supply. Because non-serialized inventory is not tracked, this leads to easier reconciliation, depending on the type of investigation product.

For example, if ten (10) kits are dispensed for a subject, but two (2) of the kits were damaged, all 10 kits are marked as Damaged By Subject. The eight (8) kits are still dispensed, but it is not specified which 2 kits are damaged because they are not tracked by kit number.

Details for clinical supply managers

When it comes to your workflow, here's what's new for you:

• On the Study Inventory tab, you can now manage both serialized and non-serialized kits. To easily identify any of these kit types, you can use the new Kit Type filter options: Serialized, Non-Serialized, or All.
• On the Study Inventory tab, you can now add kits to a lot by selecting the Add to Lot drop-down and entering the required information in the Add Non-Serialized Kit to Lot dialog.
• When specifying resupply settings, a min/max or predictive resupply strategy can be used for non-serialized kits.
• Non-serialized kits can be partially dispensed, locally sourced, and selected for a dose hold.
• Non-serialized kits cannot be individually ordered.
• Dispensation of reusable kits, site confirmation for dispensation, temperature excursion numbers, site and depot kit reconciliation are not available for non-serialized kits when both serialized and non-serialized kits are present in a study.
• On the Depot Inventory tab, non-serialized kits display by lot number and as unblinded.
• On the Depot Inventory tab, when a single lot is selected with the status of Quarantined, Quarantined Shipment Details appears in the side panel.

More information on non-serialized kit design and configuration can be found in the Sponsor and CRO User Guide and Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

Details for site users

As a site user, here's what's new for you:

• Details on non-serialized kits appear on the Site Inventory tab.
• Under Kit Types, you now have options to view All, Serialized, or Non-Serialized kits.
• For non-serialized kits, instead of a kit number, the lot number and quantity is displayed in the following user interface (UI) areas:
  • Shipments tab
  • Site Inventory tab
  • Add Shipment to Inventory dialog (when you register a shipment at a site)
  • Release Quarantined Kits dialog (when you quarantine kits at a site)
  • Dispense Kits dialog (after you dispense a non-serialized kit to a subject)

• When adding non-serialized kits to your inventory, you can enter an exact quantity of kits from the received lot you would like to add.

More information and step-by-step instructions on managing non-serialized inventory at the site level can be found in the Site User Guide after the RAE upgrade.

Impact on reports

Once the RAE upgrade is complete, additional details on non-serialized lots and counts of kits can be found in the following reports:

• Kit Inventory (Blinded) report
• Kit Inventory (Unblinded) report
• Kit Dispensation report
• Shipment Order Summary report
• Subject Events Report
• Study Design report
• Subject Visits (Blinded) report
• Subject Visits (Unblinded) report
• Titration Summary (Blinded) report
• Titration Summary (Unblinded) report

For more information, see the Reporting Guide.

Note:

Kit numbers display as lot numbers for non-serialized inventory.

Individual barcodes and tracking are not available in Oracle Clinical One Analytics for non-serialized kits. Because all tracking is removed, Oracle Clinical One Analytics datasets display the most recent view of kits by groups and quantity based on their status. Updates to the Blinded and Unblinded Kits datasets can be found in the Analytics User Guide after the RAE upgrade.

Impact on notifications

The following notifications include additional details on non-serialized inventory when non-serialized kits are dispensed:

• Unblinded dispensation notification
• Study inventory notification
• Kits quarantined notification
• Kits released from quarantine notification
• Kit status changed to "Misallocated" notification
• Kit status changed to "Not Dispensed to Subject" notification
• Subject dispensation notification

For more information, see the Notifications and Permissions Guide.

Impact on integrations

To learn more about the impact of this new feature on your existing or future integrations, see Support for non-serialized inventory for integrations.

Already working in a live study?

When the upgrade for this release is complete, to start working with non-serialized kits you must update the study design adding a non-serialized kit type. Functions for non-serialized kits in existing studies will be available, such as new filter and field options, and kit status information on the Study Inventory,Site Inventory, and Depot Inventory tabs.