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[DRUGREACTIONRELATEDNESS] Does Not Satisfy Condition Error At EMA ICSR R2 (Doc ID 2496016.1)

Last updated on MAY 05, 2021

Applies to:

Oracle Argus Safety - Version 8.1.2 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.


On a study case, when clicking Draft link of EMS ICSR R2 report on Case Form >> Regulatory Reports, ICSR cannot be generated with error dialog.
The ESM Profile of Reporting Destination code list for the report is ESM R2.


Error Message on Dialog:

Error No:402000609 Description Case <case#> General error while creating ICSR report. Value of element tag [DRUGREACTIONRELATEDNESS] does not satisfy
the condition [For EVCTM case, Relatedness must be present for every Suspect/Interacting products and Reported Events]. See report details.





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