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EMA R3 Profile - tag G.k.9.i.2.r.3.EU.1 - Error in Downgrade Report Generation (Doc ID 2446607.1)

Last updated on DECEMBER 09, 2019

Applies to:

Oracle Argus Safety - Version 8.1.1 and later
Information in this document applies to any platform.


-- Application Version

-- Problem
User has reported that cases without event reportable / related can not be reported. Validation for the report fails and report generation also fails.

User has copied the R3 profile and changed the conformance rules for EUDRUGRESULT field to Optional.

-- Error
Value of G.k.9.i.2.r.3.EU.1[EUDRUGRESULT] = 1 should exist for at least one Suspect/Interacting product and at least one of the event reported in the ICSR for cases sent to EVCTM.

-- Expected Behaviour
user expects the report to complete validation and report generation


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