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

Last updated on FEBRUARY 21, 2023

Applies to:

Symptoms

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 .

Changes

 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.

Cause

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