Support for compounding shipments

Oracle Clinical One Platform now supports the creation of compounding sites and the shipping of compounding kits, both manually and through an Oracle Clinical One Digital Gateway integration.

Before you work with this feature

As a user manager, be aware of the newly introduced permissions associated with this feature. You can assign these permissions to sponsor or site users depending on their responsibilities:

Permission	Details
Receive Compounding Shipments	Enables you to receive compounding shipments at the site you are associated with. User managers should assign this permission only when necessary. Can only be associated with custom roles. Note: This permission only enables users to view compounding shipments. Visibility for regular shipments is not included with this permission.
View Compounding Shipments to Sites	Enables you to view compounding shipments at the site you are associated with. Can only be associated with custom roles. User managers should assign this permission only when necessary.
Receive Notification of Compounding Sites	Enables you to receive a notification whenever a site administrator adds a compounding site. This permission is added to the following template roles: Study Manager Site Administrator Clinical Supply Manager - Unblinded This permission can also be applied to any custom role.
Receive Notification of Compounding Shipments	Enables you to receive a notification once a compounding kit is shipped. This permission is added to the following template roles: Clinical Supply Manager - Unblinded Clinical Research Associate (CRA) Pharmacy User - Unblinded Site User Unblinded Depot User This permission can also be applied to any custom role.

How it works

Compounding sites can be added to an Oracle Clinical One Platform study either manually by study managers or automatically, using the Master User List (MUL) - Site Tenant Integration. Clinical supply managers or depot users then assign kits to the compounding sites. In turn, kits assigned to compounding sites are delivered through compounding shipments, either automatically via the SAP Shipment Request integration, or manually by the clinical supply manager. If your study is using the SAP Supply Management System Oracle Clinical One Digital Gateway integration, kits marked as compounding can be automatically sent to compounding sites.

Details for sponsor users

As a clinical supply manager, you can now configure the new Select Shipping Address setting in the study's Supply Settings tab, part of the Shipment Settings section. This setting defaults to the first shipment address. If it is set to Yes, a user with the appropriate permission, typically a site administrator, must select the shipping address on the Kits trainstop, in the Sites & Labs tab. Otherwise, the shipment will fail, whether it is a regular or a compounding shipment.

As a site administrator, you can designate sites as compounding sites. This means you can select the new Compounding Site checkbox as you configure a site's details on the Address trainstop, part of the Sites & Labs tab in a study's settings. This marks the site address as a compounding address.

When a compounding shipment is generated, the shipment is tagged as compounding. A user with permissions to receive compounding shipments is able to receive them at the compounding site. Once received, the kits are available for dispensation at the primary site.

You can find additional information in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Details for integration managers

Note:

Sending compounding shipments to compounding sites through integrations is not mandatory. You can also send compounding shipments to compounding sites manually.

The following integrations are tied to this new feature:

SAP Shipment Request Integration: this integration processes shipment requests. Should the shipment be for a compounded kit, the SAP integration ships the kit to the compounding site.
MUL - Site Tenant Integration: this integration can now distinguish between regular and compounding site addresses. As such, it can now create compounding sites as well.

You can find additional information in the Digital Gateway User Guide after the RAE upgrade.

Details for site users

As a site user at a compounding site, you can now receive kits for compounding, provided that a sponsor user has assigned the Receive Compounding Shipments and Update Site Inventory permission to your role.

Impact on reports and Analytics

The following reporting changes are introduced for this feature:

Report	Type of change	Description
Study settings report	New column	A new Select Shipping Address column is included on the Site Address tab.
Study design report	New data point	The Setting field in the Supply Settings section now displays details about the Select Shipping Address, if configured.
Unblinded Kits dataset	New data element	A new COMPOUNDING_KITS data element is now part of the Shipment folder. This new data element indicates whether a shipment was created as a compounding shipment, and can only accept a value of Y or N.

You can find additional information in the Analytics User Guide and the Reporting Guide after the RAE upgrade.

Parent topic: Randomization and Trial Supply Management