PMDA FORM2 PAGE1 - 'Route of Administration' has Incorrect Value
(Doc ID 1616435.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 6.0.7 and laterInformation 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.
Changes
Cause
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In this Document
Symptoms |
Changes |
Cause |
Solution |
References |