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Unrelated Unlisted Event is treated as Unlisted on PMDA PSR (Doc ID 2637268.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.1.3 and later
Information in this document applies to any platform.

Symptoms

When placing asterisks * for all the unlisted events on PMDA PSR, system accounts not only related but also unlelated assessment to calculate the listedness for the events.

 

When the report is configured for Product 1 and Product 2 for the below scenario, it prints asterisk at both events.

Scenario:
------------
Event-1.......Product-1...Listed - Related
..................Product-2...Unlisted - Unrelated
Event-2.......Product-1...Unlisted - Related
..................Product-2...Listed - Unrelated

 

Current Behavior:
-------------------
Event 1 Unlisted (asterisk * is put at this event.)
Event 2 Unlisted (asterisk * is put at this event.)

 

Expected Output:
-------------------
Event 1 Listed (asterisk * is NOT put at this event.)
Event 2 Unlisted (asterisk * is put at this event.)


 

Cause

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In this Document
Symptoms
Cause
Solution
References


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