Manage non-serialized inventory

Understand how non-serialized inventory differs from serialized inventory, and how you can manage it in your study.

In some cases, your study may call for distributing non-serialized inventory. Non-serialized inventory can be useful in multiple scenarios, such as in studies with a large subject pool, or studies that call for more generalized investigational products. Because non-serialized kits are not tracked, it is easier to perform reconciliation, depending on the type of investigational product.

All non-serialized inventory is distributed in bulk, and therefore cannot be individually tracked. Instead, non-serialized kits are added to lots, and display in Oracle Clinical One Platform as lot numbers, followed by the total quantity.

Note:

Because non-serialized kits can arrive at different date and times, the Date Received column on the Site Inventory page appears blank for all non-serialized inventory.
As a clinical supply manager, you are responsible for providing sites the ability to distribute non-serialized inventory to subjects when needed. Consider the following before managing non-serialized kits:
  • Sponsor users assigned inventory management permissions have the ability to manage non-serialized inventory and distribution.
  • Non-serialized kits cannot be individually ordered.
  • Non-serialized kits assigned to a lot can be included when creating a manual shipment.
  • 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.
  • 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.'
  • Related kit status and dispensation notifications provide details for non-serialized inventory when applicable.

    For more information, see the Notifications and Permissions Guide.

There are certain kit statuses that are not supported for non-serialized kits. Also, kits in certain statuses cannot be directly updated to the statuses related to particular tasks in inventory management. For more information see Allowed updates for inventory status.

For more information and additional instructions on managing both serialized and non-serialized kits, see Manage kits at the site and study level and Manage shipments.

Parent topic: Manage kits at the site and study level