402000609 Error When E2B Viewer Is Opened (Doc ID 1591286.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

When an E2B viewer is tried to be opened for a foreign case, and if the B.4.k.5.5 is being specified
one of the following values in the case, an error message is displayed and E2B viewer does not open.

B.4.k.5.5 values which occurs the error:
-----------------------------------------
807 (Seconds)
810 (Trimester)
811 (Cyclic)
812 (As Necessary)
813 (Total)

Error Message displayed:
-----------------------------------------
エラー番号: 402000609
詳細 Case <case#> General error while creating E2b report.
値: 812が無効です。
この項目の有効な値はプロファイル:ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA - IをしようしているCFG_M2テーブルと
dtd_element:DRUGINTERVALDOSAGEDEFINITIONをチェックしてください。
格納された処置: M2_VALIDATION 報告の詳細を参照してください。

English translation of the Error Message:
------------------------------------------
Error Number:402000609
Detail Case <case#> General error while creating E2b report.
Value: 812 is not valid.
For the valid value for this item, please refer the table CFG_M2 which are using
the Profile:ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA - I and dtd_element:DRUGINTERVALDOSAGEDEFINITION.
Saved
Stored Action: Please refer the M2_VALIDATION Report Detail.

This situation will occur at the following condition.

1)
Argus Console >> Codelist: Dosage Frequency
has the following setting.

Frequency = prn / Frequency(J) = 必要に応じて
- Dosage every [#] As Necessary

2)
In a foreign case, on
症例フォーム >> 製品 tab >> 投与計画 section >> 頻度 field has '必要に応じて'.
(Case Form >> Products tab >> Dosage Regimens section >> Frequency field has 'prn'.)

At the above condition, if tried to open E2B Viewer at 症例フォーム >> 行政報告 tab (Case Form >> Regulatory Reports tab),
the above error message is displayed due to B.4.k.5.5 is 812.

Changes

Cause

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