PMDA ICSR R3 Causes F.r.2 Error Although F.r.1 Is Not Entered

(Doc ID 2371341.1)

Last updated on MAY 30, 2018

Applies to:

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

Symptoms

PMDA ICSR R3 causes F.r.2 Error although F.r.1 is not entered.

 

ERROR ON ICSR VALIDATION REPORT:

1 F.r.2.1 - TESTNAME
Case Form/Patient/Lab Data/Lab Data Test as Reported
Value for F.r.2.1[TESTNAME] should exist if F.r.1[TESTDATER3] is populated and F.r.2.2b[TESTNAMELLT] is not populated.
2 F.r.2.2b - TESTNAMELLT
Case Form/Patient/Lab Data/Lab Data Test as Reported
Value for F.r.2.2b[TESTNAMELLT] should exist if F.r.1[TESTDATER3] is populated and F.r.2.1[TESTNAME] is not available.

 

HOW TO REPEAT:
----------------------
1) Create a new case.
2) Enter data to the case for E2B R3.
3) Schedule E2B R3 for PMDA agency.
4) Click Draft link of the E2B R3 schedule.
--->E2B Viewer opens.
5) On Case Form >> Patient >> Patient sub-tab, at Lab Data block,
click [Add Test] button and [Add Date] button.
--->Lab test data space appears for one test on one date.
6) Enter text in Note field and leave all the other fields blank.
--F.r.3.4[TESTRESULTTEXT] = "Test"
--All the other fields at Lab Test are blank.
7) Click Draft link of the E2B R3 schedule.
--->I.C.S.R Validation Report opens showing error for F.r.2.1 and F.r.2.2b.

 

 

Cause

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