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 laterInformation 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
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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"
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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".
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STEPS
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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 |