ICSR PMDA R3 D.9.3 Null Flavor is not populated
Last updated on NOVEMBER 15, 2017
Applies to:Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.
D.9.3 with Null Flavor value is not generated in PMDA R3 ICSR.
Currently Null Flavor value for D.9.3 should be entered at 'UD Text 1' field on Case Form >> Patient >> Patient when generating PMDA R3 ICSR.
HOW TO REPEAT:
1)Create a case by J user.
2)On Case Form >> Patient >> Patient, enter [ASKU] in the 'UD Text 1' field.
3)Enter the other necessary field data for E2B R3.
4)Schedule E2B R3 for PMDA agency.
5)Click Draft link of E2B report.
--->E2B Viewer opens but D.9.3 item does not exist or is not printed as [ASKU].
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