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Causality Of The Event In PSUR Line Listing Do Not Match Causality Of The Event In The Case (Doc ID 2862308.1)

Last updated on JUNE 13, 2022

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.


Case with only 1 Event
Event Assessment tab
Causality as Reported: Result - set to "Not Reported".
Causality as Determined: Result - set to "Not Related".

Analysis tab
Case Summary section
Case Agent Causal set to No

In the PSUR line listing the event has Causality set to Yes.
It would be expected behavior that the Causality would be No.

In the Console > System Configuration >System Management > Reporting > Periodic

Inclusion criteria for cases in the ICH PSUR/CTPR report is set to:


Please confirm if the event causality data from the PSUR is derived from the As Reported or As Determined Causality?


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