E2B(R3) Codes For Event Outcome Do Not Allow A '0' (zero) For Unknown (Doc ID 2190745.1)

Last updated on JULY 13, 2023

Applies to:

Goal

According to the table (E.i.7) in the FDA document “Guidance for Industry” E2B(R3) Electronic transmission of Individual Case Safety Reports (ICSRS) Implementation Guide:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm274966.htm

The following codes should be used for Event Outcome:

1 = recovered/resolved
2 = recovering/resolving
3 = not recovered/not resolved/ongoing
4 = recovered/resolved with sequelae
5 = fatal
0 = unknown

When trying to set Unknown to ‘0’, the following message is displayed:

"E2B code must be between 1 and 9."

Steps to reproduce the issue:
The issue can be reproduced at will with the following steps.
Console > Code Lists > Argus > Event Outcome
Click on Unknown
Change value from '6' to '0'
Save
Get message:
E2B code must be between 1 and 9.

Why can't the Event Outcome value be updated to '0'?
 

Solution

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