Mandatory Error at D.5 Item on PMDA ICSR Validation Report

(Doc ID 2326452.1)

Last updated on NOVEMBER 09, 2017

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.


When any of D.1, D.1.1.1-D.1.1.4, D.2.1、D.2.2a, D.2.2b, D.2.2.1a, D.2.2.1b, D.2.3 element data exists but D.5 is null in a case,
PMDA ICSR Validation Report is generated with indicating D.5 is mandatory when E2B R3 report is tried to be generated.


1) Create a new case.
2) On Case Form >> Patients, enter Patient Initial (D.1) and Gender (D.5) only.
3) Enter rest data to the case for E2B R3.
4) On Case Form >> Regulatory Reports, schedule E2B R3 report for PMDA agency.
5) Click Draft link. --->E2B Viewer opens.
6) On Case Form >> Patients, remove Gender filed value. Save the case.
7) On Case Form >> Regulatory Reports, click Draft link. --->PMDA ICSR Validation Report opens.
#: 1
ICSR Field Location: Case Form/Patient/Patient Information/Gender
Error Description: Mandatory element missing.


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