The SMART-TRIAL AE Module is built with automatic notifications for certain time sensitive events. Which notifications are sent, depends on the Sponsor Involvement that has been selected when creating the AE form.
In SMART-TRIAL there are up to three actors involved with an AE/SAE:
The reporter
The investigator
The sponsor
A reporter will never receive notifications, as their role is the first step of the AE flow. Sponsor and investigators will receive notifications when it is their turn to take action on the AE/SAE.
What types of notifications are there?
There will always be an in-app notification, and in time sensitive cases an email will be sent.
How do I receive notifications?
Receiving notifications requires the correct permissions for the site where AE/SAEs are reported.
Anyone with the "Investigator AE" permission will receive notifications meant for investigators. Likewise anyone with the "Sponsor AE" permission will receive notifications meant for sponsors.
NOTE: Sponsor and Investigator AE permissions are site specific! That means if there are Investigator permissions for site A, and an SAE is reported on site B, no notification will be sent to that investigator
Can monitors receive notifications?
Monitors will not receive notifications as a default. Only users who have to act on the AE/SAE (i.e. enter data into the AE report) will receive notification when it is their turn to act.
There is the option of giving monitors the "sponsor AE" permission, but that does mean they will be able to fill in any sponsor fields, and sign the AE report as a sponsor.
Otherwise our Study Notifications can be used to send a notification every time an AE/SAE is reported in the study.
Why does the Sponsor Involvement determine who receives notification?
If "Never involve sponsor" was selected, the sponsor role will never have to partake in the AE/SAE flow, and will therefore not receive notifications. Only users who need to take action will receive notifications.
AE/SAE Notification overview
The tables below should be read in the following way:
The left column "Event" is an event that can happen in the AE module. If there is an 'x' in either the 'Investigator' or 'Sponsor' column they will receive an in-app notification.
If there is an 'x' in "Send Email" an email will be sent in addition to the in-app notification.
An example:
For "SAE created" both the investigator and sponsor will receive an in-app notification AND an email.
Always involve sponsor
| Event | Investigator | Sponsor | Send Email |
| AE created | x | ||
| SAE created | x | x | x |
| AE changed to SAE | x | x | x |
| AE investigator assessment signed | x | ||
| SAE investigator assessment signed | x | x | |
| SAE sponsor classification sign | |||
| AE follow up ready (All questions with mandatory = "Follow up" completed) | x | ||
| SAE follow up ready (All questions with mandatory = "Follow up" completed AND sponsor classification signed ) |
x | x | |
| AE follow up signed | x | ||
| SAE follow up signed | x | x | |
| SAE sponsor final sign | |||
| AE changed (data edited) | |||
| SAE changed (data edited) |
Involve on sponsor on SAE
| Event | Investigator | Sponsor | Send Email |
| AE created | x | ||
| SAE created | x | x | x |
| AE changed to SAE | x | x | x |
| AE investigator assessment signed | |||
| SAE investigator assessment signed | x | x | |
| SAE sponsor classification signed | |||
| AE follow up ready (All questions with mandatory = "Follow up" completed) | x | ||
| SAE follow up ready (All questions with mandatory = "Follow up" completed AND sponsor classification signed) |
x | x | |
| AE follow up signed | |||
| SAE follow up signed | x | x | |
| SAE sponsor final sign | |||
| AE changed (data edited) | |||
| SAE changed (data edited) |
Never involve sponsor
| Event | Investigator | Sponsor | Send Email |
| AE created | x | ||
| SAE created | x | x | |
| AE changed to SAE | x | x | |
| AE investigator assessment signed | |||
| SAE investigator assessment signed | |||
| AE follow up ready (All questions with mandatory = "Follow up" completed) | x | ||
| SAE follow up ready (All questions with mandatory = "Follow up" completed) | x | ||
| AE follow up signed | |||
| SAE follow up signed | |||
| AE changed (data edited) | |||
| SAE changed (data edited) |