Waiving an AER

You can waive an adverse event report (AER) when the regulatory authority issues an exception or the adverse event occurs outside the country of the regulatory authority.


Before you begin:
See Also
Creating Adverse Event Reports
Modifying AER Details
  1. Perform any one of the following actions.
    • From the Adverse Events Reports page, select the required AER, and from the page toolbar select Actions > Waive.
    • From the Adverse Events Report Properties page, in the Basic tab toolbar, click Waive.
    The Waive Adverse Events Report page appears.
  2. Select the reason to waive the AER from the Default Reason list.

    You can select any one of the following options.

    • FDA has issued an exemption
    • Occurred outside Canada with no manufacture intent of corrective action
    • Competent Authority has issued an exemption

  3. Optional: If you want to provide a different reason, type the reason in the Other Reason (overrides default) box.
  4. Click Done.
    The AER is waived.

The state of the AER is set to Waived.