About pooling kits in a study

With pooled kits and shipments, you can create a centralized supply management for your investigational product. Learn more about the specifics and limitations of this feature in the application.

Details about designing and configuring a pooled kit

Consider the following when designing a pooled kit type:

• An existing kit type cannot be changed to a pooled kit type. If you need to design a pooled kit, you have to create that kit from scratch.
• If your study contains pooled kits and non-pooled kits, the system ships kits separately: pooled kits are shipped in one shipment, while non-pooled kits are shipped in another system. To make sure that your study preserves its blind, single kit ordering is not allowed when your study contains pooled kits.
• A kit's pooling ID must be unique in each study. You can have multiple kits with pooling IDs in a study, as long as those IDs are always unique.

For more information on how to create a pooled kit, see

Details about pooled kits in the study's inventory

Consider the following when creating shipments or kit lists in a study that has pooled kits:

• The sidebar on the Shipments tab only displays the details of a shipment containing pooled kits after the kit receipt is received by a depot user or the clinical supply manager.
• For pooled kits, label group assignments are not restricting you when it comes to shipping of these kits. For example, even though pooled kits may be labeled for a specific country, you can still choose to ship those kits to different countries, depending on how you've set up your resupply strategy. Because kits are managed in a centralized manner, you have more control over where you ship them.
• When it comes to kit lists, you should know that any pooled kits in your study are grouped in a system-generated kit list automatically named Pooled. Any other pooled kits you may create in an ongoing study will get included in that system-generated kit list.
• You cannot deactivate a kit list containing pooled kits.
• For all of the kit types that are not pooled, you can upload or generate a separate kit list. In this other kit list, you cannot include or import pooled kits. If all kits in your study are pooled, you cannot upload or generate a kit list for your study.

Details about lots and shipments

Consider the following when it comes to lots or manufacturing batches in your study:

• You can only ship pooled kits through a supply integration. For example, if you want to generate a manual shipment containing pooled kits, that shipment is sent through an integration. If you want to start drug pooling for your studies, work with your Oracle Project Manager to find the best solution for integrating your study with a supply vendor. In the meantime, remember the following details about shipping pooled kits:
  • A pooled shipment's ship date can only be updated through an integration. As a clinical supply manager or depot user, you can still manually specify a tracking number for a pooled shipment or cancel it.
  • As part of an integration, a stock report runs daily and updates the quantities in the lot. The counts of kits assigned to a lot are managed through the daily integration of this stock report.
• Values for the DNS (Do Not Ship) Days and DNC (Do Not Count) Days are calculated using the Manufacturing Lot Expiry Date specified in a study's supply settings the first time the country is added to the lot. You can only update this value in the User Interface (UI), not through an integration.
• A clinical supply manager or depot user cannot add or remove kits from a pooled shipment.
• Depot-to-depot shipments that contain pooled kits are also managed outside of the application.

Details about pooled kits and supply integrations

The following supply integrations are not sending data on pooled kits:

• Almac Global Depot Network
• Catalent Clinical Supply Services
• Fisher Clinical Services
• SmartSupplies PMD

Note:

The related topics below display the workflow of creating a pooled kit. As stated above, to ship pooled kits, you must work with your Oracle Project Manager to configure the appropriate integration in your study.