Control depot users' access

Sponsor users can now restrict access for depot users and control what they can view in the application on a study-to-study basis.

Before you work with this feature

As a user administrator or any other sponsor user, you must be aware of the following changes introduced for permissions and study roles:
  • Blinded Depot User is a new permission that lets the user access the new Depot Inventory tab and provides access to view the kit numbers, but doesn't see the descriptions for all blinded and Unblinded Pharmacist kits.

    Caution:

    Use with caution. The Blinded Depot User permission grants access to view the Sequence Number, which could potentially unblind the study for blinded site users and blinded sponsor users.
  • Blinded Depot User is also introduced as a new template study role. The study role contains several existing permissions compiled to give the adequate access to a depot user who must be blinded in a study.
  • To unblind the Blinded Depot User study role, add the permission Create Shipments to Depots that exposes all kit descriptions to the blinded depot user.
  • The existing Clinical Supply Manager study role template is modified to include the new Blinded Depot User permission.
  • The following permissions are no longer unblinding:
    • Receive Notification of Depot Shipment
    • Release Shipments from Quarantine
    • Receive New Shipments at the Depot
    • Receive and Reconcile Shipments at the Depot

You can find additional information on the Add Users Guide after the Release Assessment environment (RAE) upgrade.

Details for blinded depot users

If you're a depot user who is assigned the Blinded Depot User permission or study role, here's what's new for you:
  • To view supplies at a specific site or all sites, request permission from your user administrator.
  • On the Study Supplies page, you can view a new tab called Depot Inventory.
  • The Depot Inventory tab displays data on a study's blinded inventory and contains columns, such as: Kit Number, Sequence Number, Block Number, Kit Description, Status, Expiration Date, and Units per Kit.
  • On the new tab, you can filter blinded kits by depot, status, blinded lot, shipment ID, and quarantine ID. Also, you can search for kits by kit or sequence number.
  • You can update the status of kits in your depot's inventory to Available, Dispensed, or Quarantined.
  • The word blinded now appears in the search bar or for filters to indicate that some treatment descriptions may be unavailable to the blinded depot user.
  • As a blinded depot user, you cannot modify the inventory received at a site, as per contract, except for releasing kits from quarantine, if you have the appropriate permissions. You also cannot view the full description of kits, as well as upload or generate kit lists.

You can find additional information on the Depot User Guide, after the Release Assessment environment (RAE) upgrade.

Details for user administrators and sponsor users

As a sponsor user, here are some new things you can do to control a depot user's access:

  • You can let each depot user only view shipments for their assigned depots.
  • As a clinical supply manager, you can remove the location from the kits when they are assigned to the depot in error. For example, if you didn't receive the kit to the site, you can change it back to the depot.
  • If you want to give a blinded depot user viewing access to the Site Inventory tab, you must assign one or more sites in the study to the depot user. By default, a blinded depot user doesn't have access to the Site Inventory or the Study Inventory tab.
  • If you want to give a blinded depot user access to view Unblinded Pharmacist kits, assign them with the View Unblinded Pharmacist Kits permission.

You can find additional information on the Sponsor and CRO User Guide, after the Release Assessment environment (RAE) upgrade.

Impact on reports

The following reports will reflect depot user activity:

You can find additional information about these reports on the Reporting Guide after the RAE upgrade.