No initial PMDA E2B (R3) was auto-scheduled after the nullification report
(Doc ID 2517245.1)
Last updated on SEPTEMBER 04, 2019
Applies to:Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.
The PMDA E2B (R3) nullification report which was scheduled manually from the regulatory report tab has already been submitted to agency.
This case received the follow-up information.
Although the current case data is matched with the criteria of the reporting rule, a new initial E2B (R3) dose not automatically schedule.
This issue does not occur if the nullification report had been scheduled automatically (such as when deleting the case and/or by AG service).
1. Create a case
2. Enter the mandatory information for PMDA E2B (R3)
3. Save the case
4. Go to the regulatory report tab
5. Press the [Auto Schedule] button
6. The initial report was scheduled by reporting rule
7. Close the case
8. Submit and transmit the report
9. Receive ACK
10. Open the case
11. Go to the regulatory report tab
12. Schedule the nullification report manually
13. Save the case
14. Generate the final report
15. Close the case
16. Submit and transmit the report
17. Receive ACK
18. Open the case
19. Go to the regulatory report tab
20. Press the [Auto Schedule] button
No initial report was scheduled even though the current case data is matched with the criteria of the reporting rules.
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