Pool kits easily across studies

Global users who are assigned the appropriate roles and permissions can now define and manage pooled kits across studies at their organization.

As opposed to defining kit types for a single study only, pooling kits lets you strategically distribute the investigational product across different studies. In turn, you can now create powerful supply strategies that can significantly reduce drug overages and preserve supplies for all study patients.

Note:

You can find more information in the following user guides, after the Release Assessment (RAE) upgrade:

Add Users Guide
Sponsor and CRO User Guide
Study Designer User Guide

Before you work with this new feature

As a global user manager or a user administrator, you should know that your workflow hasn't changed. However, there some new roles and permissions that you need to be aware of. The following new global roles and permissions are new or modified:

New role or permission	Description
Create and Edit Library Kits for Pooled Supplies	This is a global role. You can assign this role to a library user or a study designer so that they can create and edit a kit while it has a status of Draft in a library study.
Approve Library Kits for Pooled Supplies	This is a global role. You can assign this role to a library user or a study designer so that they can approve a kit in a library study.
Delete Library Kits	This is a global role. You can assign this role to a library user or a study designer so that they can delete kits in a library study.
Create Manual Shipments (Unblinded)	This is an existing permission that is updated to become unblinded. This means that whoever is assigned this permission can now view pooled kits to include them in a shipment request. WARNING: This update partially unblinds a depot user if they are granted this permission. You are not restricted or prevented from assigning a user with this permission as this change doesn't present the risk of compromising your study's integrity.

Details for library managers and study designers

If you're a library manager, here's what's new for you:

On the Library page, you can now see a new tab called Kit Types.
With the right role, you can now create or edit kit types in a library study, and import them into a Production study.
When defining a kit type as a library object, you can specify several details for it, such as the pooling ID, a description, as well as information about its storage requirements and the units per kit.
In your study's library, on the Kit Types tab, you can also change the status of a kit to any of the available statuses: Draft, Approved, Published, and Archived.
On the Kit Types tab, you can monitor the entire history of a kit type in a library study.

If you're a study designer, here's what's new for you:

In a study's design, on the Kits tab, you now have a new button called Import Kit Type that takes you to the study's library where you can choose which kits to import.
Upon selecting a kit to import, you can define its usual details that you specify when you create a kit type in your Production study.

Details for clinical supply managers and depot users

Whether you're a clinical supply manager or a depot user, here's what's new for you:

When creating shipments, you now have to specify the manufacturing lot ID for a pooled kit type. For example, if you want to create a shipment that contains multiple types of kits, and one of those kits is pooled, you need to select a manufacturing lot ID for that specific pooled kit type. When a shipment that has both pooled and non-pooled kits is created, the system generates separate shipment order - one for pooled kits and one for non-pooled kits.
On the Shipments tab, you can see the specific category of a shipment in the new Category column. This column indicates whether the shipment is pooled or not.
The system doesn't generate a kit order form for a shipment that contains pooled kits until the shipment is returned (and it has an In Transit status).
When it comes to kit lists for pooled kits, you cannot deactivate or upload a kit list when that kit list contains pooled kits. Pooled kits are dynamically uploaded to the database as they are submitted in the integration file from the depot.

Details for site users

As a site user, there are no workflow changes for you. However, you should know that anytime you register a pooled shipment at your site, the receipt will contain the kit numbers, as usual. The lot numbers and the kits' sequence numbers are displayed only if you have unblinded access to the study.

Details for integration managers

If you're an integration manager and the study you're working with is integrated with another supply system, here's what you need to know:

A pooled manual shipment can be raised through this integration by specifying the kit type and the kit count in the integration template. Pooled shipments can also be generated automatically as part of a study's resupply strategy.
You or another user cannot add or remove kits from a pooled shipment.
A pooled shipment's date is sent to the supply system as part of the integration. Another user cannot modify that pooled shipment's date in the User Inteface (UI).
A pooled shipment that is sent from one depot to another is handled outside of the system. For an Oracle Clinical One Platform user, this means that they cannot modify the shipment in Oracle Clinical One Platform.