Manage locally sourced kits

When defining inventory settings, sponsor users can now include locally sourced kits and allow site users to manage their dispensation.

You can now configure locally sourced kits for your studies to accommodate their many needs, such as:

Sites may need different kit types to be sent to different locations due to storage purposes.
The protocol utilizes multiple kit types distributed by different depots.
A drug is approved in a specific geographical area, but not in another.

Details for sponsor users

As a sponsor user, here's what you should be aware of when it comes to your workflow:

On the Supply Settings tab, a new section called Locally Sourced Kit Settings is now displayed. In here, you can add a kit and define its details so it can be locally sourced.

Note:
The kit type must be set to Unblinded at the time it is created in order for it to be available to be locally sourced.
Any kit type within a specific titration event can be selected to be added as locally sourced. Once a kit has been added and saved as locally sourced, the kit type cannot be edited.
Multiple countries can be selected and added to either Locally Sourced Countries or Sourced by Site Countries.

Note:
A country can only be added to either Locally Sourced Countries or Sourced by Site Countries, but not added to both.
All locally sourced countries must be removed in order to disable or delete a locally sourced kit.

More information and step-by-step instructions on configuring locally sourced kits can be found in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Details for site users

When it comes to your workflow, here's what you should know:

Information on locally sourced kits is provided in the dispensation details and Subject History.
The Subject Dispensation notification includes details on locally sourced kits for users assigned one or all of the following permissions:
- Receive the Dispensation Notification
- Receive the Dispensation with Dosing Instructions Notification
- Receive the Unblinded Dispensation Notification

More information on this notification can be found in the Notifications and Permissions Guide after the RAE upgrade.

Impact on reports

Updates to the following reports can be found in the Reporting Guide after the RAE upgrade:

Already working in a live study?

As soon as the upgrade for this release is complete, you can begin locally sourcing kits in existing studies.

Parent topic: Randomization and trial supply management