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PMDA ICSR validation error with A.1.5.1 serious displays when viewing the downgrade report (Doc ID 1680795.1)

Last updated on MARCH 18, 2019

Applies to:

Oracle Argus Safety Japan - Version 6.0.7 and later
Information in this document applies to any platform.


By the follow-up information, the reported event(s) was non-reportable event.
When view the downgrade report, PMDA ICSR Validation error for A.1.5.1 serious is displayed.

1. Create S/U/R case, lock case.
2. Schedule, generate and submit PMDA initial report.
3. Receive ACK with PMDA ACK Number
4. Unlock the case as significant follow-up
5. Update listedness to Listed OR update causality to Not Related
6. Schedule a downgrade report
7. Click the Draft link

PMDA ICSR Validation Error report displays:
OTHER validation error for A.1.5.1 SERIOUS


Note: Using the (Default) PMDA-I profile


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