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Unexpected Unit Is Generated At F.r.4 and F.r.5 In HL7 Of PMDA R3 ICSR (Doc ID 2346076.1)

Last updated on DECEMBER 24, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.


When case has Lab Test Unit, Norm Low, Norm High and Assessment values, HL7 format data generated from the case has incorrect unit value at F.r.4 and F.r.5 sections.


1) Create a new case and enter data to the case for E2B R3 report.
2) Go to Case Form >> Patient tab >> Lab Data block.
Enter data;
- Lab Data Test as Reported = Blood glucose,
- Test Name = Blood glucose
- Units = mg/dL,
- Norm Low = 100,
- Norm High = 200
- Test Date = 29-DEC-2016
- Results = 150,
- Assessment = Borderline,
- Notes = Test Note
3) Schedule E2B R3 for PMDA.
4) Click Draft link of E2B R3 report. I-C-S-R Viewer opens.
Change View Format = HL7 View on I-C-S-R Viewer.
---> The generated HL7 has right unit value.


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