PMDA FORM2 PAGE1 - 'Route of Administration' has Incorrect Value (Doc ID 1616435.1)

Last updated on MARCH 28, 2016

Applies to:

Oracle Argus Safety Japan - Version 6.0.7 and later
Information in this document applies to any platform.

Symptoms

When a case is having '投与経路' = '非経口' on 症例フォーム >> 製品 tab, and generate a 別紙様式1/2 report,
the 様式2(一)page prints '経路' = '親'.

( Case Form >> Products 'Patient Route of Administration' = 'Parenteral' and
PMDA Form-2 Page-1 prints 'Route of Administration' = 'Parent'. )

This occurs on both Marketed and Clinical PMDA Form-1/2 report.

 

Cause

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