Sending A Follow Up To An Existing Adverse Event

Creating an Adverse Event (AE) Follow-Up Report

After an initial report has been sent to Pharmacovigilance (PV), a follow-up AE report can be created within En3.

To create a follow-up report:

1. Navigate to the Follow-Up tab area
2. Click the “+” button
3. Select Follow-Up 1 (or the next available follow-up option)

Each follow-up tab includes a unique identifier, which consists of:

• The original AE ID sequence
• The last four digits, representing the Follow-Up ID

Adverse Event (AE) Follow-Up Details

When a new follow-up is created, key fields are automatically populated from the original report, including:

• Patient Details
• Product ID
• Follow-Up Consent

Completing and Sending a Follow-Up

Once all additional required fields have been completed, a follow-up email can be sent using the same process described for the original AE report.

En3 supports multiple follow-up reports. However, for this pilot, the number of follow-ups is limited to three.

How To Fill Out Adverse Event Request

Medical Inquiry Send Email Form