Adverse Event Report Lifecycle

The Adverse Event Report (AER ) lifecycle consists of six states.

This page discusses:

Create

In this state, the owner or quality manager can modify AER details and waive AERs.

In this state, the reviewer can review the information and approve the task, which promotes the AER to Submission Approval state.

In this state, you can submit and waive AERs.

In this state, you can complete AERs when you get response from the regulatory body.

In this state, you can only view the details of the AER.

In this state, you can un-waive AERs