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General Error No. 402000609 When Generating The Final E2B Report (Doc ID 2698702.1)

Last updated on FEBRUARY 21, 2023

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.


Draft report generate without error but when generating the final one the following error prevents E2B report generation :
Error No. 402000609 Description case 2020Oracle1 General Error while creating ICSR report Value of Element tag [DRUGREACTION RELATEDNESS] does not satisfy the condition [For EVCTM case. Relatedness must be present for every Supect/Interacting products and Reported Events .


 This was verified  - EU code for the Causality source is either 1 or 2 (Investigator and Sponsor) and the relatedness (Causality category is a 2) so it is either 1, 2 or 2, 2 which fall  under:
Mandatory for EVCTM cases that has C.1.3[REPORTTYPE] = 2 and C.5.4[OBSERVESTUDYTYPE] = 1.

Each product and event combination in Event assessment must have at least one record for As reported or As company data entered containing below data:
1. valid Causality source (allowed values are 1, 2, or 3),
2. valid Causality result (allowed values are 1 or 2)

We had the error in the Draft and was corrected to the above which removed the error in the draft. However we still have the error upon generating the Final version.


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