Generating a new safetyreportid in the follow-up PMDA E2B after the downgrade report
(Doc ID 2141805.1)
Last updated on FEBRUARY 18, 2019
Applies to:Oracle Argus Safety Japan - Version 7.0.7 and later
Information in this document applies to any platform.
When viewing/generating the PMDA E2B follow-up report after the downgrade report, the different A.1.0.1 <safetyreportid> has been assigned.
It supposed to be the same A.1.0.1 as the previous report.
1. Generate initial PMDA E2B report with A.1.0.1 <safetyreportid> including 'AA' as suffix (eg., JP-ORACLE-16JP000118AA)
2. Transmit the report
3. Receive ACK
4. Open the case
5. Go to the regulatory report tab
6. Confirm that the status of initial report is set as "Submitted"
7. Unlock the case
8. Update the case data
9. Save the case
10. Schedule downgrade report
11. Lock the case
12. Generate the downgrade report with A.1.0.1 <safetyreportid> including 'AA' as suffix (eg., JP-ORACLE-16JP000118AA)
13. Transmit the report
14. Receive ACK
15. Open the case
16. Go to the regulatory report tab
17. Confirm that the status of downgrade report is set as "Submitted"
18. Unlock the case
19. Update the case data
20. Save the case
21. Schedule follow-up report
22. View the draft report
A.1.0.1 <safetyreportid> is assigned with 'AB' as suffix (eg., JP-ORACLE-16JP000118AB) and this is not the same as previous report.
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