Issue With WHO DRUG Dictionary And The ACTIVESUBSTANCE Statement In EMA OOTB Profile
(Doc ID 2216588.1)
Last updated on JANUARY 04, 2021
Applies to:Oracle Argus Interchange - Version 8.1 and later
Information in this document applies to any platform.
Oracle Argus 8.1
Issue with WHO DRUG Dictionary and the ACTIVESUBSATANCE statement.
When a valid WhoDrug has been added to case and correctly encoded, when attempting to generate a draft E2B using out of the box EMA profile, generation fails with warning below:
The following element is a MANDATORY element and must contain data: ACTIVESUBSTANCENAME.
Stored procedure: GENERATE_SAFETYREPORT See report details.
Steps to reproduce issue
- Add any drug from the WHO drug dictionary (e.g. REMICADE with the active ingredient INFLIXIMAB). But can be any valid drug from WHODrug Dictionary.
- Complete required E2B fields
- Schedule Manually and Generate an E2B using an reporting destination having using the default shipped EMA ICH-ICSR V2.1 MESSAGE TEMPLATE – EMA profile
- Note, the following above error message(s) are displayed
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