ICSR PMDA R3 Does Not Create F.r.3.3 When Test Unit Value Is °C

(Doc ID 2329993.1)

Last updated on NOVEMBER 19, 2017

Applies to:

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

Symptoms

Even if Test Result (F.r.3.2) and Test Unit (F.r.3.3) have value on Case Form >> Patient >> Patient, and if the Test Unit value is °C (Celsius degree),
ICSR PMDA R3 does not generate the F.r.3.2 and F.r.3.3 items on its generated ICSR R3.

 

If Test Result Code (F.r.3.1) or Test Result Text (F.r.3.4) has value, the existing F.r.3.1 and/or F.r.3.4 is/are generated on ICSR PMDA R3, but F.r.3.2 and F.r.3.3 are not.

 

If both Result Code (F.r.3.1) and Test Result Text (F.r.3.4) do not have value and both Test Result (F.r.3.2) and Test Unit (F.r.3.3) have value and the value of F.r.3.3 is °C (Celsius degree),
ICSR PMDA R3 generation fails with validation error (generating ICSR Validation report).

ICSR Validation Error when both Result Code (F.r.3.1) and Test Result Text (F.r.3.4) do not have value and both Test Result (F.r.3.2) and Test Unit (F.r.3.3) have value and the value of F.r.3.3 is °C (Celsius degree);

条件付き必須項目
-------------------
1 F.r.3.2 - TESTRESULT
F.r.2 (F.r.2.1/F.r.2.2a/F.r.2.2b)が入力されており、F.r.3.1 [TESTRESULTCODE]およびF.r.3.4 [TESTRESULTTEXT]が空白である場合、F.r.3.2 [TESTRESULT] (およびF.r.3.3[TESTUNIT])の値を指定する必要があります。
-------------------
2 F.r.3.1 - TESTRESULTCODE
F.r.2(F.r.2.1/F.r.2.2a/F.r.2.2b)が入力されており、F.r.3.2[TESTRESULT](およびF.r.3.3[TESTUNIT])およびF.r.3.4[TESTRESULTTEXT]が空白である場合、F.r.3.1[TESTRESULTCODE]の値を指定する必要があります
-------------------
3 F.r.3.4 - TESTRESULTTEXT
F.r.2(F.r.2.1/F.r.2.2a/F.r.2.2b)が入力されており、F.r.3(F.r.3.1/F.r.3.2/F.r.3.3)が空白である場合、F.r.3.4[TESTRESULTTEXT]の値を指定する必要があります。

 

Conditional Mandatory
-------------------
1 F.r.3.1 - TESTRESULTCODE
Value for F.r.3.1[TESTRESULTCODE] should exist when F.r.2(F.r.2.1/F.r.2.2a/F.r.2.2b) is populated and F.r.3.2[TESTRESULT] (along with F.r.3.3[TESTUNIT]) and F.r.3.4[TESTRESULTTEXT] are blank.
-------------------
2 F.r.3.2 - TESTRESULT
Value for F.r.3.2[TESTRESULT] (along with F.r.3.3[TESTUNIT]) should exist when F.r.2(F.r.2.1/F.r.2.2a/F.r.2.2b) is populated and F.r.3.1[TESTRESULTCODE] and F.r.3.4[TESTRESULTTEXT] are blank.
-------------------
3 F.r.3.4 - TESTRESULTTEXT
Value for F.r.3.4[TESTRESULTTEXT] should exist if F.r.2(F.r.2.1/F.r.2.2a/F.r.2.2b) is populated and F.r.3(F.r.3.1/F.r.3.2/F.r.3.3) is blank.

 

HOW TO REPEAT:
----------------------
1) Create a new case.
2) On Case Form >> Patient >> Patient, enter one Lab Test Data.
Test Date = 01-NOV-2017
Test Name = Body temperature
Test Result = 36 ------------ F.r.3.2
Test Unit = °C ------------- F.r.3.3
Test Result Text = Normal --- F.r.3.4
3) Enter rest data for E2B.
4) On Case Form >> Regulatory Reports, schedule E2B R3 for PMDA agency.
5) Click Draft link of E2B report.
E2B Viewer opens.
--->
F.r.3.2 and F.r.3.3 items do not exist though F.r.3.4 exists.

 

 

Cause

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