A safety notification records that the investigator sites must be told about a safety finding. Canary decides that a notification is required; Compend sends the safety letter to each site’s investigator file and tracks each site’s read receipt. Canary does not send the letter itself.
Raise a notification
You can notify the sites from two places:
- A SUSAR case. Open the case on Cases. The Site notification section sits under the case’s SUSAR reporting.
- A validated signal. Open the signal on Signals. The Site notification section appears once the signal is validated.
Select Notify sites and confirm. Canary records the requirement and hands it to Compend, which distributes the letter. A case or signal that has already been notified shows the date it was raised and whether it has been acknowledged, instead of offering a second notification.
Notifications can also be raised for an expedited-reportable case (serious and causally related). These appear in the same list with the reason Expedited- reportable case.
Follow open notifications
The bell in the topbar lists the notifications still awaiting acknowledgement. Select Open notifications to go to the full list.
The Safety notifications page shows every notification with its reason, the product and reaction it concerns, a link to the case or signal it came from, the date it was raised, and its state. Use Show to switch between Awaiting acknowledgement, Acknowledged and All notifications.
Acknowledge a notification
Once the safety team has acted on a notification, select Acknowledge on its row and confirm. The acknowledgement is recorded in the audited trail and cannot be undone.
Acknowledging in Canary does not confirm that every site has read the letter. Each site’s read receipt is tracked in Compend’s safety distributions.
When a list can’t be read
If Canary cannot read the notifications, the page and the case or signal section say so and offer Retry. An unreadable list is never shown as “nothing awaiting acknowledgement”.