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PMDA ICSR Validation Error When Accept E2B at E2B Import (Doc ID 1636327.1)

Last updated on DECEMBER 05, 2019

Applies to:

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


When executing 'E2Bの受託' at 報告 > 処理待ちのE2B報告 ('Accept E2B' at Reports > Incoming E2B Reports >> [Pending] tab) screen
for a Follow-up E2B record after a follow-up E2B Zip file is imported, the following error message is displayed and E2B is unable to be accepted.

Error Message:
PMDA ICSR検証基準が、症例と現在処理待ちのE2B報告との比較・インポートに失敗しました。
PMDA ICSR検証を満たすように症例データを改正する必要があります。
対象の症例のPMDA ICSR検証報告を表示しますか?

(In English, "PMDA ICSR Validation Report failed to compare / import the case with the E2B Report which is pending now.
You need to modify case data to satisfy PMDA ICSR Validation Report. Shall we open the PMDA ICSR Validation Report for the case?")



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