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

Last updated on OCTOBER 19, 2016

Applies to:

Oracle Argus Safety - Version 8.0.1 and later
Information in this document applies to any platform.

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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