Incorrect Listedness and Causality values are printed at PMDA Event Reportability block on Print Case Form output

(Doc ID 2324005.1)

Last updated on NOVEMBER 01, 2017

Applies to:

Oracle Argus Safety Japan - Version 7.0.3 and later
Information in this document applies to any platform.

Symptoms

When case is having data at Case Form >> Events >> Event Assessment:
--Listedness = Unlisted
--Causality = No,
Print Case Form >> [PMDA Event Reportability] block prints
--Listedness (As per Datasheet / As per Case) = Data not entered
--Causality (As Reported / Determined Causality) = Data not entered

On Japanese UI:
症例フォーム >> 有害事象 >> 有害事象評価:
--既知/未知 = 未知
--因果関係 = 関係なし
プリント症例フォーム >> [PMDA有害事象報告対象] block:
--既知/未知 (データシートによる評価 / 症例上の評価) = 入力なし
--因果関係 (報告された / 決定された因果関係) = 入力なし



Cause

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