Unblinded Drug Order Form for Quantum integrated studies

Unblinded Drug Order Forms (DOF) for shipment requests, fulfillment, and manual requests can now be generated for Quantum-integrated studies, supporting regional regulatory requirements.

The Unblinded DOF provides kit details and, when fulfilled, kit and lot numbers for your Quantum-integrated study, supporting shipment activities. The DOF is generated on demand for initial, resupply, and manual pooling kit shipments for users with the appropriate permissions.

Before you work with this feature

Sponsor users assigned the Receive Notification of Quantum Drug Order Form (Unblinded) permission receive the Kit Order Form [Requested/Fulfilled] notification.

Additionally, sponsor users assigned the View the Quantum Drug Order Form permission are able to view and download generated DOFs.

More information on these permissions can be found in the Add Users Guide and Notifications and Permissions Guide after the assessment environment upgrade completes.

Details for sponsor users

As a sponsor user, you can generate an Unblinded Drug Order Form (DOF) for your Quantum-integrated studies when an initial, resupply, or manual shipment is created.

• The Unblinded DOF includes the following details:
  • Kit ID
  • Kit description
  • Minimum expiration date (for initial and resupply shipments)
  • Lot number (for manual shipments)
  • Quantity requested
• Once the shipment request is fulfilled, the DOF is updated to display kit and lot numbers, where applicable.
• The Unblinded Drug Order Form can be downloaded in HTML format. Users with the appropriate permissions can regenerate, resend, and download the form.

  Note:

  Blinded users who are not assigned the View Quantum Drug Order Form permission will not see the option to download the Drug Order Form.

Step-by-step instructions and additional information can be found in the Sponsor and CRO User Guide after the assessment environment upgrade completes.

Impact on reports, extracts, archives, or datasets

Report, extract, archive, or dataset	Type of change	Description
Global Study Roles report	Modified column data	The Permissions column includes details on newly created unblinded permissions for Receive Notification of Quantum Drug Order Form and View the Quantum Drug Order Form when applicable.
Study Roles report (by study)	Modified column data	The Permissions column includes details on newly created unblinded permissions for Receive Notification of Quantum Drug Order Form and View the Quantum Drug Order Form when applicable.

Already working in a live study?

Once the assessment environment upgrade completes, Drug Order Forms can be generated for existing Production studies that use Quantum integrations.