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 JULY 13, 2023

Applies to:

Goal

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:

Evaluate seriousness, listedness, relatedness, fatal across all diagnoses/events against product (Seriousness, listedness, relatedness, fatal attributes from all of the diagnoses-product combination in the case will be evaluated for case inclusion. If no diagnosis is present, then all events in the case will be evaluated).

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

Solution

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