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

(Doc ID 2346068.1)

Last updated on JUNE 28, 2018

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.

Symptoms

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

 

Steps to repeat#1:
-----------------------
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.

その他の致命的な検証
# ICSR項目ICSRフィールドの位置エラー詳細
1 J2.1b - MHLWADMICSRCASENUMB
症例フォーム / 解析 / PMDA情報 / 一般 / 被疑薬ライセンスの情報
追加報告では、次の項目の値が以前の報告の対応する項目と一致する必要があります
・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
1 J2.1b - MHLWADMICSRCASENUMB
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).

 

 Steps to repeat#2:
-----------------------
1) Create a new case and enter data to the case for E2B R2.
2) Transmit Initial ICSR R2 report.
3) Import ACK and submit the initial ICSR report.
4) Generate and Transmit F/U#1 ICSR R2 report.
5) Change the Agency from R2 to R3 at Reporting Destination code list.
6) Unlock the case as Significant Follow-up.
7) Schedule F/U#2 of ICSR R3 report.
8) Click Draft link of F/U#2 of ICSR R3 report.
--->ICSR Validation Report opens with the same message of Steps to repeat#1.

 

 

Cause

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