Creating And Filling In Adverse Event Form

To add a Adverse Event Request, click the “+” button in the Requests section located on the left side of the Inquiry form.

After clicking the “+” button, a new adverse event form is created and ready to be filled in. We explore the different items and functions in the image below. 

1. AE EN3 ID: Unique AE ID produced by En3 
2. Follow-up Tabs: Includes the initial report and any AE Follow-ups initiated afterwards 
3. AE PV ID: Unique AE ID produced by the PV database and used for reconciliation purposes 
4. Patient Details: Includes age and gender of patient 
5. Product ID: Refers to the product Batch and Serial Number for identification purposes 
6. Date and Time of Awareness: Specific to when the MI department became aware of the Adverse Event 
7. Date and Time Transmitted to PV: En3 generated timestamp when AE is reported to PV 
8. Follow-up consent: Drop-down selection for follow-up consent 
9. AE Description (Original & Translated): Description of the Adverse event in native language and English translation 
10. Upload Files Area: Manually upload any documents which may need to be sent to the Safety department 

Inquiries Form Fields Marking