English Listedness Justification Text Is Deleted (while Japanese Left As Is) In Event Assessment (Doc ID 2428198.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

On Applications Oracle Life Sciences Argus Safety Version : 8.0.1

English listedness justification text is deleted (while Japanese remains as it was) in event assessment

When the MedDRA coded term is changed, English for justification text ("Known / unknown change reason") becomes blank in the Event Assessment screen, when changing automatically calculated justification.

If English is blank in the "Known / unknown change reason" column, Case locked, When the case is opened again, the justification returns to the calculated value.


Steps to Reproduce:

• [Case Actions]
• New
• Create a new case with Product = Company Product
• First Event = Any e.g. Angina Pectoris - MedDRA Code Selected
• Marked as Serious (Medically Signicant)
• [Bookin] Case
• Open this Case
• Split screen (Japanese Left - English Right)
• Select [Event Assessment] tab
• For the Event e.g. 'Angina Pectoris'
• Set As Reported Causality and As Determined Causality = 'Possible' (or similar value)
• Note in this example the listedness was auto set to 'Listed' based on datasheet
• Change this manually to another value e.g. 'Unlisted'
• A Pop-up box appears with 'Please enter a justification for performing this action:' should appear
• In the Listedness Justification, enter text for both languages
• Click [OK]
• Save the case.
• Note that the listedness change is reflected on the right hand (English) screen as expected.
• Return to [Event Assessment] in same case and change listedness from dropdown in the Japanese display.
• In the Listedness Justification, edit text for both languages (different text for each to help identify)
• [Save] the case.
• Navigate to [Events] screen
• Change the existing event to a new value in Japanese screens e.g. 片頭痛 (Migraine) that auto-encodes to new dictionary code via MedDRA
• Save Case
• English Event is also updated with details
• Go to [Event Assessment] screen once more.
• Note the Event has correctly changed, however if click on green icon to view existing Listedness Justification the english text has now disappeared, but Japanese remains the same per last added by user

Changes

Cause

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