Enhancements to support studies using pooled kit supplies

This release includes enhancements to pooled kit supply reporting, shipment processing, and blinded lot notification management in Clinical One Cloud Service.

Projected Supply (Unblinded) Report Enhancements for Pooled Kit Studies

The Depot tab in the Projected Supply (Unblinded) report has been enhanced for studies using pooled kit supplies. The report now displays depot-level inventory quantities for pooled kits based on the latest uploaded stock file, and it updates available counts as shipment requests are processed.

Two new columns, Shipping to Country and Location Code, have also been added to provide additional depot shipment and location details. Inventory counts reset upon upload of a new stock file to reflect the current depot inventory state.

Impact on reports, extracts, archives, or datasets
Report, extract, archive, or dataset Type of change Description
Projected Supply (Unblinded) report New column added to the Depot tab Shipping to Country: Displays the country approved for shipments from the depot.
Projected Supply (Unblinded) report New column added to the Depot tab Location Code: Displays the Shipping Point configured for the depot in tenant-level depot setup.

Enhancements for Single Kit Ordering in Pooled Kit Studies

Shipment processing for pooled supplies has been enhanced to help maintain the study blind when single kit ordering is not allowed.

For pooled supplies configured with Single Kit Ordering Allowed set to No, the system now automatically adds an additional kit of the same kit type when a shipment request would otherwise contain only one pooled kit. This behavior applies regardless of kit classification, including blinded, unblinded, and unblinded pharmacist kits. Shipment requests containing multiple pooled kit types are not adjusted when the shipment already contains more than one kit.

New Country Associated to Lot Notification

A new notification, New Country Associated To Lot, has been added to help unblinded clinical supply teams identify when DNS (Do Not Ship) and DNC (Do Not Count) values may need to be updated for affected blinded batches.

The notification is triggered whenever:
  • A new country is associated with an existing blinded lot, or
  • A new blinded lot is created in Clinical One Cloud Service.

This can occur through stock file uploads or manual lot maintenance workflows.

Permissions:

Users assigned to a Sponsor study role that includes the Receive Blinded Lot Country Association Notification permission receive this notification.