Incorrect Allowed Values (Doc ID 2362627.1)

Last updated on DECEMBER 04, 2023

Applies to:

Symptoms

For data element DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2b] and DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2b],
the following incorrect records are found for Description and Description(J) for code 007,039 & 052.

====
Code: 007
Description: ENDOTRACHEAL
Description(J): 気管内 (Endo-)

Code: 039
Description: INTRATRACHEAL
Description(J): 気管内 (Intra-)

Code: 052
Description: PERARTICULAR
Description(J): PERARTICULAR
====

The expected correct records are as follows.

====
Code: 007
Description: ENDOTRACHEAL
Description(J): 気管内（Endotracheal）

Code: 039
Description: INTRATRACHEAL
Description(J): 気管内（Intratracheal）

Code: 052
Description: PERIARTICULAR
Description(J): 関節周囲
====

Steps to reproduce:

1. Login to Argus Safety Japan
2. Go to Argus Console > System Configuration > Interchange Mapping > Manage Profile
3. Select 'ICH-ICSR V3.0 MESSAGE TEMPLATE - PMDA' in the profile dropdown list
4. Look for DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2b]
5. Click on Allowed Values button
6. Observed values for Description, Description(J) for code 007,039 & 052.
7. Look for DRUGPARROUTEOFADMINTERMID [G.k.4.r.11.2b]
8. Click on Allowed Values button
9. Observed values for Description, Description(J) for code 007,039 & 052.

Changes

Cause

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