Reporting Adverse Event To PV

Once all the information is completed, we can send the Adverse Event to PV by selecting the envelope icon on the top right of the Adverse Event screen. 

A new window will pop-up similar to the Case escalation environment including a summary of the AE information as well as an xml file to be sent to the relevant safety department. 

Key elements on screen include the following: 

1. Send AE Report Email: Button to send the AE report 
2. Template Selection: Drop-down menu selection to select appropriate template 
3. PV Email: Specifically assigned to the project and should populate automatically 
4. AE Subject with ID: AE Subject with En3 ID 
5. AE Summary: Summary of AE information included in the previous screen 
6. AE xml transmission: xml file is included automatically as attachment 

Once the user has verified the information, the AE report can be sent to PV. A timestamped record of the AE report will appear at the bottom of the screen below the Upload Files area, labelled Case Email References as per picture below. 

Inquiries Form Introduction

Creating And Filling In Adverse Event Form