VACCAT EVAERS Validation Error On Downgrade Report When Vaccine Product Deleted
(Doc ID 2741609.1)
Last updated on DECEMBER 04, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1.3 and laterInformation in this document applies to any platform.
Symptoms
Is there a work-around/solution for an eVAERS downgrade report error?
An Initial eVAERS report was successfully submitted to FDA CBER with an Influenza Vaccine product (License type: Marketed Vaccine).
During the addition of case follow-up the Vaccine product was deleted and replaced with a "Not Otherwise Specified" Drug Product. Due to this product change the case no longer meets the reporting rule to CBER for the vaccine product and a downgrade was scheduled for the vaccine reporting rule.
Following are exact steps to reproduce the issue:
1. Create a new case with a vaccine product.
2. On the product tab enter Facility Type as "Unknown"
3. Schedule, generate and submit an eVAERS report and mark it as submitted from an auto-schedule rule.
4. Delete the vaccine product and replace it with a drug product.
5. Auto schedule new reports and observe a downgrade schedules for the vaccine product.
6. The downgrade report is unable to generate and results in an error message related to the VACCAT E2B field.
Error message:
In earlier versions of the case with the Influenza vaccine product the Facility Type field was set to "Unknown". It is not possible to enter that info now under a drug product.
Does the SQL need to be modified to account for this (ex. if NULL defaults to 'UNK")?
Is there an alternative front-end fix to meet regulatory requirements?
Changes
Cause
To view full details, sign in with your My Oracle Support account. |
|
Don't have a My Oracle Support account? Click to get started! |
In this Document
Symptoms |
Changes |
Cause |
Solution |