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Inclusion criteria of PSUR/CTPR for 'Most severe event for the product' (Doc ID 1945291.1)

Last updated on JUNE 26, 2019

Applies to:

Oracle Argus Safety - Version 6.0.5.1 and later
Information in this document applies to any platform.

Goal

When the Common Profile Switch 'Inclusion criteria of event for a product in the PSUR/CTPR' is set to
'Most severe event for the product (First left most Diagnosis Related Serious Event with most weight on Diagnosis then relatedness and then seriousness)',
how is the event determined, among the multiple events in a case, when printing PSUR/CTPR?


Common profile switch location:
Argus Console
..|--System Configuration
.......|--System Management (Common Profile Switches)
............|--Common Profile
.................|--Reporting
......................|--Periodic
...........................|--Inclusion criteria of event for a product in the PSUR/CTPR

 


 

Solution

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In this Document
Goal
Solution


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