by Courtney Kennedy, Clinical Research Advisor
With direction and approval from research leadership, the notification that an enrolled study participant has been admitted to our campus is being re-instated in March 2016. This tool is being implemented to assist with timely adverse event reporting as required by FDA regulations. When live, an alert will appear in both the Principal Investigator’s and Coordinator’s In Basket when a participant has been either admitted to our hospitals or visits the ER.
Notifications will be sent only for study patients who are actively enrolled in an Interventional or Therapeutic study. This alert does not apply to participants enrolled in a registry or single blood draw studies.
The alerts will be automated therefore it is imperative that study personnel changes be sent to Courtney Kennedy (402-552-2983 or firstname.lastname@example.org) so that the notifications can be directed to the appropriate persons. Although the notifications will be automated the coordinators will still need to routinely check their In Basket ->Research Notification folder to see if any of their study patients have had an event.
The In-Basket functionality is NOT currently operational. You will be notified before the alerts begin.