D.7.1.r.1a Error When Generating ICSR R3 For PMDA

(Doc ID 2337617.1)

Last updated on DECEMBER 10, 2017

Applies to:

Oracle Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.

Symptoms

When creating ICSR R3 for PMDA by clicking Draft link on Case Form >> Regulatory Reports, D.7.1.r.1a error appears on ICSR Validation Report.

 

Error on ICSR Validation Report:
-----------------------------------------

ICSR検証報告
--------------------------------------
#: 1
--------------------------------------
ICSR項目: D.7.1.r.1a - PATIENTEPISODENAMEMEDDRAVERSION
--------------------------------------
ICSRフィールドの位置: Case Form/Patient/Other Relevant History/Description of condition LLT
--------------------------------------
エラー詳細:
報告で使用されるMedDRAバージョンはすべて同じである必要があります。
バージョンの次の項目を確認してください:
D.7.1.r.1a - [PATIENTEPISODENAMEMEDDRAVERSION] (患者の治療歴のMedDRAバージョン)
D.8.r.6a - [PATIENTINDICATIONMEDDRAVERSION] (患者の対象疾患のMedDRAバージョン)
D.8.r.7a - [PATIENTDRGREATIONMEDDRAVERSION] (患者の医薬品副作用のMedDRAバージョン)
D.9.2.r.1a - [PATIENTDEATHREPORTMEDDRAVERSION] (報告された死因のMedDRAバージョン)
D.9.4.r.1a - [PATIENTDETERMAUTOPSMEDDRAVERSION] (剖検により決定された死因のMedDRAバージョン)
D.10.7.1.r.1a - [PARENTMDEPISODEMEDDRAVERSION] (親の治療歴のMedDRAバージョン)
D.10.8.r.6a - [PARENTDRGINDICATIONMEDDRAVERSION] (親の対象疾患のMedDRAバージョン)
D.10.8.r.7a - [PARENTDRGREATIONMEDDRAVERSION] (親の医薬品副作用のMedDRAバージョン)
F.r.2.2a - [TESTNAMEMEDDRAVERSIONLLT] (検査名のMedDRAバージョン)
G.k.7.r.2a - [DRUGINDICATIONMEDDRAVERSION] (医薬品使用理由のMedDRAバージョン)
H.3.r.1a- [SENDERDIAGNOSISMEDDRAVERSION] (送信者の診断のMedDRAバージョン)

 

ICSR Validation Report
--------------------------------------
#: 1
--------------------------------------
ICSR Element: D.7.1.r.1a - PATIENTEPISODENAMEMEDDRAVERSION
--------------------------------------
ICSR Field Location: Case Form/Patient/Other Relevant History/Description of condition LLT
--------------------------------------
Error Description:
All MedDRA versions used in the report should be the same.
Check in the Meddra version following elements:
D.7.1.r.1a - [PATIENTEPISODENAMEMEDDRAVERSION] (Patient Medical History)
D.8.r.6a - [PATIENTINDICATIONMEDDRAVERSION] (Patient Indication)
D.8.r.7a - [PATIENTDRGREATIONMEDDRAVERSION] (Patient Drug Reaction)
D.9.2.r.1a - [PATIENTDEATHREPORTMEDDRAVERSION] (Reported cause of death)
D.9.4.r.1a - [PATIENTDETERMAUTOPSMEDDRAVERSION] (Autopsy-determined causes of death)
D.10.7.1.r.1a - [PARENTMDEPISODEMEDDRAVERSION] (Parent Medical History)
D.10.8.r.6a - [PARENTDRGINDICATIONMEDDRAVERSION] (Parent Indication)
D.10.8.r.7a - [PARENTDRGREATIONMEDDRAVERSION] (Parent Drug Reaction)
F.r.2.2a - [TESTNAMEMEDDRAVERSIONLLT] (Test Name)
G.k.7.r.2a - [DRUGINDICATIONMEDDRAVERSION] (Drug Indication)
H.3.r.1a - [SENDERDIAGNOSISMEDDRAVERSION] (Sender's diagnosis).

 

 

 

Cause

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