Error In E2B R3 Report Generation For The Element "G.k.9.i.2.r.2.EU.1 [EUDRUGASSESSMENTMETHOD] " (Doc ID 2381942.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

On Applications Oracle Argus Safety Version : 8.1.1

Attempting to import a test XML file downloaded from European Medicines Agency (EMA) website for the scenario "EEA SUSAR-patient death".

The XML has a primary suspect drug and a secondary drug.

The XML imports with errors.

The primary suspect drug is not coded as a company product as it is not configured in the application and the second drug changed instead of secondary drug as company drug.

If then attempt to generate an E2B R3 report get the error per below:

The issue can be reproduced  with the following steps.

1. Import sample xml per Attachment: 1a._EEA_SUSAR-patient-death.xml
2. Substitute spare drug in xml with company product
3. Once accepted from this generate an R3 E2B
4. Warning is reported.

Changes

Cause

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