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ICSR validation error for B.4.k.2.2 ACTIVESUBSTANCENAME appears for the follow-up ICSR (Doc ID 2528221.1)

Last updated on DECEMBER 05, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 to 8.2 [Release 8.1 to 8.2]
Information in this document applies to any platform.


There is the blind study case which was created prior to v8.1 and this study has not key-opened yet.

On version 8.1 or higher, system received and imported the follow-up ICSR (R2 format) file to this blind study case.

In reports > pending ICSR, when executing the "difference check" or accepting this follow-up ICSR, the following error with ICSR validation error appears.
ICSR Validation criteria has failed for the case against which current incoming ICSR report is being compared/imported.
Please correct the case data to satisfy ICSR Validation criteria.
Do you want to view the ICSR Validation Report for the target case?

(Japanese message)
ICSR 検証基準が、症例と現在症例町のICSRF報告との比較・インポートに失敗しました。

When click OK to this message, the mandatory validation error appears for B.4.k.2.2 ACTIVESUBSTANCENAME.



Steps to replicate the issue:
On version 8.1 or higher

1. Find the blind study which was created prior to 8.1.x (e.g., v8.0.1) and confirm the followings:
         a) This study has not key-opened yet
         b) Go to the product tab > view this blind study product tab. confirm that no substance information exists (because this study has not key-opened)
         c) Check the case_prod_ingredient table and no record exists for the study product

2. Import follow-up ICSR (R2 format) file
3. Go to reports > ICSR pending
4. Select the imported ICSR record and display the duplicate search window
5. Run the [View Difference] button

The GENERAL_ERROR appears.
Click OK to this message so that mandatory ICSR validation error appears for B.4.k.2.2

6. Press the [Accept ICSR] button

The same GENERAL_ERROR and ICSR validation error appear.


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