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

Last updated on JULY 13, 2023

Applies to:

Symptoms

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.
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GENERAL_ERROR
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。
ICSR検証基準を満たすように症例データを改正する必要があります。
対象の症例のICSR検証報告を表示しますか？
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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.

Cause

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