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EVALUATIONVALUE Device Codes 8.9.9.98 (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.

Goal

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:

Error No:402000609 Description Case 1911153US General error while creating ICSR report. The value: 3035 is invalid. For a list of valid values for this element, please check the table CFG_M2 using profile: ICH-ICSR V2.2 MESSAGE TEMPLATE - FDA (AGN V8.1.2) and dtd_element: EVALUATIONVALUE. Stored Procedure: M2_VALIDATION


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?
 

Solution

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In this Document
Goal
Solution
References


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