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Unable to set the justification text for non-research reporting category in PMDA info tab (Doc ID 2508918.1)

Last updated on OCTOBER 06, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.

Symptoms

The justification text for non-research reporting categories has been set in the analysis > PMDA info tab.

However, the user cannot set the justification again because no green dot icon displays next to the reporting category field.

 



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STEPS
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1. Open the case which has Japan license
2. Go to analysis > PMDA info tab
3. Set the reporting category (eg., B - Domestic ADR for Mkt Drug) for Japan MKT license
4. Enter or select the justification reasons
5. Confirm that the green dot icon appears next to reporting category field
6. Save the case
7. The green dot icon disappears

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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