Auto Schedule Does Not Create Downgrade but Followup schedule for a Downgrade Case (Doc ID 1570522.1)

Last updated on MARCH 08, 2017

Applies to:

Oracle Argus Safety Japan - Version 7.0.1 and later
Information in this document applies to any platform.

Symptoms

In the following Japan downgrade scenario, the auto reporting schedule does not indicate "*Downgrade*", but "*Followup*"

on the Case Form > Regulatory Reports tab screen.

Is this the expected result in Argus?


Scenario Assumption
The case has three events.
For not reportable events, “報告に含まない” (not reportable checkbox) is not ticked.

Initial
Event #1 and #2 are reportable
Event #3 is not reportable due to no causality relationship

FU#1 ? follow-up report
Event#1 is still reportable
Event#2 becomes not reportable due to no causality relationship
No change in event#3 (still not reportable)

FU#2 ? downgrade report
Event#1 becomes not reportable due to no causality relationship
No change in Event#2 & 3 (still not reportable)

 

Cause

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