Why SUSAR Event Classification included in Post Marketing cases (Doc ID 1615759.1)

Last updated on JULY 05, 2016

Applies to:

Oracle Argus Safety - Version 6.0.7 and later
Information in this document applies to any platform.

Goal

Question 1:

Why is this kind of classification is included in report for Post Marketing Cases and not only for Clinical Cases?
 
Question 2:

SUSAR Classification is related to cases from clinical studies.
ICH PSUR is a report that usually includes only cases from post marketing (excluding clinical studies)

Question 3:

Why has Oracle opted to design the SUSAR classification in a report only dedicated to post marketing cases?

Solution

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