J2.1b Error of ICSR Validation Is Raised When Follow-up #1 ICSR R3 for PMDA

(Doc ID 2346068.1)

Last updated on JANUARY 07, 2018

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.


Follow-up #1 ICSR R3 for PMDA is unable to be generated with J2.1b Error on ICSR Validation Report.


Steps to repeat:
1) Create a new case and enter data to the case for E2B R3.
2) Schedule E2B R3 for PMDA and confirm ICSR Viewer opens.
3) Lock the case, generate the Initial ICSR report.
4) Transmit Initial ICSR report.
5) Import ACK and submit the Initial ICSR report.
6) Unlock the case as Significant Follow-up.
7) Schedule F/U#1 of the submitted ICSR report.
8) Click Draft link of F/U#1 ICSR report.
--->ICSR Validation Report opens.

# ICSR項目ICSRフィールドの位置エラー詳細
症例フォーム / 解析 / PMDA情報 / 一般 / 被疑薬ライセンスの情報
・報告区分(J2.1a) ・ID番号(J2.1b) ・メッセージ送信者ID (N.2.r.2) ・世界的に固有の症例ID (C.1.8.1)

The same error message in English:

Other Fatal Validation
# ICSR Element ICSR Field Location Error Description
Case Form/Analysis/PMDA/General/PMDA Identification Number
For Follow-up Reports the values of following elements should match with the corresponding elements in the Previous
・Report classification (J2.1a) ・Identification number (J2.1b) ・Message sender identifier (N.2.r.2) ・Worldwide unique case identifier (C.1.8.1).




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