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The follow-up local report was scheduled (Doc ID 2307149.1)

Last updated on DECEMBER 17, 2024

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.0.1 and later
Information in this document applies to any platform.

Symptoms

The option "Even when previously scheduled reports are neither submitted nor marked for "submission not required" is selected in the common profile switch.


Argus Console > System configuration > Common profile switch > Reporting > Expedited
-----------------------------------------------------------------
Allow generation of report:

[_] Only when previously scheduled reports are submitted or marked for "submission not required"
[X] Even when previously scheduled reports are neither submitted nor marked for "submission not required"
-----------------------------------------------------------------

 

Issue is that the follow-up local report was scheduled even though the status of the previous local report is set as "submission not required".

 


---------------------------------------------
STEPS
---------------------------------------------
1. Create a new case
2. Enter the mandatory value for book-in
3. Book-in

4. Open the case
5. Enter the mandatory value for PMDA E2B
6. Lock the case (Note: Confirm that the case was globally locked and locally locked now)

7. Go to regulatory reports
8. Press the [Auto Schedule] button
9. Confirm that initial PMDA E2B (as local report) was scheduled

10. Generate the final report
11. Change the status to Submitted

12. Press the [Auto Schedule] button
13. Confirm that follow-up report (local report) was scheduled
14. Change the submission required as NO

15. Press the [Auto Schedule] button

Follow-up report was scheduled

Cause

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In this Document
Symptoms
Cause
Solution
References


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