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Error 402000609 with field length appears for ACTIVESUBSTANCENAME (Doc ID 2011500.1)

Last updated on OCTOBER 23, 2017

Applies to:

Oracle Argus Safety Japan - Version 7.0.3 to 8.1 [Release 7.0.0 to 8.1]
Information in this document applies to any platform.

Symptoms

When viewing PMDA E2B from the imported case which includes the WHO Drug with many activesubstancename,

the length over error appears for B.4.k.2.2 ACTIVESUBSTANCENAME of who-drug so we cannot view the report.

 

Error

Error#:402000609

Details: Case #### General error while creating E2b report.

項目ACTIVESUBSTANCENAMEの文字数は、ICHの規定により100以下である必要があります。現在の文字数:###. 格納された処置: M2_VALIDATION 報告の詳細を参照してください。



Steps to reproduce:

  1. Import the ICSR with WHO-drug which has many <activesubstancename>/ingredients

    For example:

                  <activesubstance>
                                  <activesubstancename>Chinese licorice</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>Sichuan pepper</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>calcium carbonate</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>cinnamon</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>clove</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>coptis</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>fennel</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>ginger</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>menthol</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>silodrate</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>sodium bicarbonate</activesubstancename>
                  </activesubstance>
                  <activesubstance>
                                  <activesubstancename>taka-diastase</activesubstancename>
                  </activesubstance>

  2. Accept this ICSR
  3. Open the imported this case
  4. Enter tha mandatory information for PMDA E2B
  5. Go to the regulatory report tab
  6. Schedule PMDA E2B
  7. Click Draft link

    Error#:402000609 appears for ACTIVESUBSTANCENAME

Cause

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In this Document
Symptoms
Cause
Solution
References


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