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ICSR Validation Error "Currency Flag (English Language) Should Be Y" Appears When Viewing PMDA E2B (Doc ID 2778307.1)

Last updated on MAY 25, 2021

Applies to:

Oracle Argus Safety Japan - Version 8.2 and later
Information in this document applies to any platform.

Symptoms

The following ICSR validation error appears when viewing PMDA E2B although the case has the event with currency flag as Yes(Y).

 

Other Fatal Validation:

The designated MedDRA code should be in the master, and the currency flag (English language) should be Y.

 

For example:

 

 

Note:

New version of MedDRA/J dictionary has been loaded recently.

However, when loading the dictionary, it was accidentally loaded without ticking the "MedDRA J" check-box.

 

Since this dictionary was loaded incorrectly, dropped the MedDRA User schema and Roles for this dictionary loading.

Re-loaded the new version of MedDRA dictionary with "MedDRA J" check-box into the different MedDRA User schema name and different Roles.

In Argus Console > System management > System management (Common Profile Switch), this re-loaded dictionary is selected in the "Events & Indications" section and all the events in the case were coded with the new version of this dictionary.

 

 

Steps to replicate the issue :

1. Open the case in English case view mode

2. Go to the event tab (or the other tab which shows the validation errors)

3. Confirm that event is coded with green check icon. This means this is currency Y event.

4. Enter the necessary information for PMDA E2B

5. In the regulatory report tab, schedule the PMDA E2B (R3)

6. Save the case

7. Click the DRAFT link or run the PMDA ICSR Validation report by clicking the "Status" icon

ICSR validation error report appears with the following errors.

The designated MedDRA code should be in the master, and the currency flag (English language) should be Y.

 

Cause

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In this Document
Symptoms
Cause
Solution
References

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