New subject and shipment notifications

Subject and shipment monitoring play a crucial role in the outcome of any clinical study. With the right roles and permissions, users in a study can now receive notifications every time a randomization or dispensation visit is complete or not, as well as when a shipment is cancelled.

What are the benefits?

The Subject randomization and Subject dispensation notifications inform you whether a dispensation or randomization visit was successfully completed or failed to complete. Additionally, you receive data such as the subject ID, as well as the site where the visit took place, the date, and visit name. Depending on the roles you are assigned in the study, you can also receive details about the treatment arms, kit descriptions and dosing instructions. This way you can effectively react to any change concerning your subjects.

The Shipment cancellation notification keeps you updated on the shipment status and alerts you every time a shipment is cancelled. This notification includes details such as the shipment number, the date the shipment was cancelled, as well as the study name and the site name.

Details for user administrators

Your workflow hasn't changed, but there are some new rights that you need to be aware of. Users must have these rights associated with their assigned roles in order to receive these notifications.

If a user who should receive these notifications already has the role that includes these rights, there's no need to make any changes. The user will be able to receive these notifications immediately after the system update.

Type of notification	Created when...	Roles & permissions	Details
Subject randomization (unblinded)	An unblinded randomization visit is completed at a site you are assigned to.	Following roles should include the Receive the Unblinded Randomization notification permission: Clinical supply manager Randomization list manager	Includes treatment details.
Subject randomization (blinded)	A blinded randomization visit is completed at a site you are assigned to.	Following roles should include the Receive Randomization notification permission: Subject notifications	Doesn't include treatment details. However, if current randomization is unblinded, users with this right also receive details about treatment arms.
Randomization failure	Randomization of a subject failed to complete at a site you are assigned to.	Following roles should include the Receive the Randomization Failure notification permission: Randomization list manager	N/A
Subject dispensation (unblinded)	An unblinded dispensation visit is completed at a site you are assigned to.	Following roles should include the Receive the Unblinded Dispensation notification permission: Clinical supply manager	Includes a kit description for each kit number.
Subject dispensation (blinded)	A blinded dispensation visit is completed at a site you are assigned to.	Following roles should include the Receive Dispensation notification permission: Subject notifications	Includes the kit description only if the dispensed kits are of unblinded distribution type. If they're not, kit description isn't disclosed in this notification.
Subject dispensation with dosing instructions	A dispensation visit with kits including calculated doses is completed at a site you are assigned to.	Following roles should include the Receive the Dispensation with dosing instructions notification permission: Site user with detailed dosing view	N/A
Dispensation failure	A dispensation visit failed to complete at a site you are assigned to.	Following roles should include the Receive the Dispensation Failure notification permission: Site user with detailed dosing view Subject notifications Clinical supply manager	N/A
Shipment cancellation	A shipment is cancelled.	Following roles should receive this notification: Clinical supply manager Unblinded Depot User Shipment notification	Includes the shipment number, the date the shipment was cancelled, and the site name.

Details for sponsor and site users

Once you have the appropriate roles and permissions, you receive these notifications over email and see them when you click the notifications button, on the Home page, next to your study ID.

Already working in a live study? As a site or sponsor user, you can get provisioned with the correct roles and permissions to receive these notifications as soon as the system upgrade is complete.

Need help accessing the notifications? See View notifications.