EVALUATIONVALUE Device Codes 22.214.171.124
(Doc ID 2638468.1)
Last updated on MARCH 03, 2020
Applies to:Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.
When generating an E2b file for the FDA using the new ICH-ICSR V2.2 MESSAGE TEMPLATE - FDA profile the following error message is displayed:
Upon investigation user sees that not all values allowed for selection on the Medwatch Device screen exist in the CFG_M2 table. The following query helps identify the missing values. Use the ESM schema owner:
Were the missing codes left out intentionally? Do these values need to be added into the CFG_M2 table or are they supposed to be excluded?
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