The Japanese event is not displayed after importing ICSR without <primarysourcereaction>
(Doc ID 2042624.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 7.0.5 to 8.0.1 [Release 7.0.0 to 8.0]Information in this document applies to any platform.
Symptoms
When importing ICSR which does not have the value in B.2.i.0<primarysourcereaction> tag (eg., <primarysourcereaction/>),
this event is encoded and populated properly in English case view.
However, in Japanese case view, the event does not encode so text ** Not Translated ** is displayed.
Note: This issue occurs in any message profile(FDA/EMA/PMDA).
Steps:
Prerequisite : MedDRA/J has been configured in common profile option.
1. Import I.C.S.R which does not have the value in B.2.i.0 <primarysourcereaction> tag
eg, -- Chills (10008531)---
<reaction>
<primarysourcereaction/>
<reactionmeddraversionllt>17.0</reactionmeddraversionllt>
<reactionmeddrallt>10008531</reactionmeddrallt>
<reactionmeddraversionpt>17.0</reactionmeddraversionpt>
<reactionmeddrapt></reactionmeddrapt>
<reactionoutcome>6</reactionoutcome>
</reaction>
2. Accept this ICSR
3. Open the case and change the case view mode to English
4. Click the event tab
5. Confirm that event "Chills" is encoded properly withMedDRA/J
6. Change the case view mode to Japanese
The text ** Not Translated ** is displayed and the encoding events(SOC-LLT)are not populated.
Cause
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In this Document
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