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PMDA E2B (R3) Downgrade Report Has Validation Errors After Changing Study Drug (Doc ID 2836075.1)

Last updated on JANUARY 28, 2022

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.



The following ICSR validation error appears when viewing PMDA E2B (R3) downgrade report.


ICSR validation errors:

                Error Description : Case Value for J2.4.k[MHLWSTATUSCATEGORYOFNEWDRUGS] must exist for primary product.

            Error Description : Mandatory element missing.

    Conditional Mandatory
                Error Description :
                  Value for J2.8.2[MHLWREASONFORUTOFRPTCRITERIA] should be present only if J2.8.1[MHLWFLAGFORUTOFRPTCRITERIA] is present and equal to 1
                  otherwise J2.8.2[MHLWREASONFORUTOFRPTCRITERIA] should be blank.

    Other Fatal Validation
               Error Description :
                 For Follow-up Reports the values of following elements should match with the corresponding elements in the Previous
                ・Report classification (J2.1a) ・Identification number (J2.1b) ・Message sender identifier (N.2.r.2) ・Worldwide unique case identifier (C.1.8.1).




The study has the several study products.

These study products have the same drug information but the drug form is different.

Each product has the different Japan Invetigational license but each license has the same clinical compound number (CCN).

After submitting E2B, the study drug was changed to the others which has the different drug form and this case no longer has the SUSAR event.

System auto-scheduled the follow-up (downgrade) report and validation errors appear when viewing this report.


Steps to replicate the issue:


For example,

a) In Argus Console > Business Configuration >Studies, Unblind Study(A) has been configured with the following two study products

b) Each product has the different Japan INV license in Argus Console > Business configuration > Products and Licenses

1. Create a study case with this Study(A)
2. In the general tab, confirm that study (A) information is displayed
3. Go to the product tab which shows the text "Study Drug" in the Company Drug Code field
4. In the "Study Drug" field, select "Product ABC" with drug form: Tablet
5. Enter the mandatory value for PMDA E2B
6. Save and lock the case

--- Schedule initial PMDA
7. In the regulatory report tab, press the [Auto schedule] button
8. Confirm that initial PMDA E2B was auto-scheduled to Japan INV license "License 001" from the product ABC with drug form "Tablet"
9. Generate the final report
10. Close the case form

10. Transmit and submit the initial PMDA E2B
11. Receive ACK

12. Unlock the case as significant info
13. In the product tab, change the study drug to "Product ABC" with drug form "Intravenous Infusion"
14. Change the case data (for example, the case no longer has SUSAR event)
15. Save and lock the case

16. In the regulatory report tab, press the [Auto schedule] button

Follow-up (downgrade) report was auto-scheduled.
However, the report was scheduled to the Japan license "License 001" from the previous product with drug form "Tablet".

17. Click the draft link of the downgrade report

ICSR validation errors appear.




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