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Cannot change PMDA E2B status as submitted when using "F/U Action Item for Incomplete submission of Report" (Doc ID 1613257.1)

Last updated on FEBRUARY 25, 2019

Applies to:

Oracle Argus Safety Japan - Version 7.0.3 and later
Information in this document applies to any platform.


When trying to manually submit the E2B completion report to PMDA,  the error "J unable to create or update case action item on E2B submission" displays.


   1. Login to Argus as Argus-J user account
   2. Navigate to Argus Console > System Configuration > Common Profile
   3. Navigate to (menu tree) Argus-J > Reporting
   4. Confirm that action type has been configured to 'Follow Up Action Item for Incomplete submission of Report'

   5. Open the case > Analysis > PMDA Info > General tab

   6. Check the completion flag and enter the mandatory value for PMDA E2B completion report
   7. On the regulatory report tab, schedule PMDA E2B
   8. View the report

       eg., In view format : J-SGML, J.6 <mhlwadmicsrcompleteclass> is set as 2 (Compleation)

   9. Transmit the E2B from bulk reporting
   10. Confirm that the zip file has been generated under OUT folder

   --- Change the report status manually ---
   11. Navigate to Worklist > Bulk E2B Transmit  (Or on case form > regulatory report tab)
   12. Select the record and view the report details window
   13. In the routing tab, change the status as Approved
   14. In the routing tab, change the status as Submitted
   15. Press OK. The following error appears so we cannot change the E2B status as submitted.

    *** J Unable to create or update case Action Items on E2B submission


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