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Old ACK Number Displays in PMDA E2B (R3) Follow-up Report (Doc ID 2683224.1)

Last updated on JUNE 26, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

Issue :

Old ACK Number displays on PMDA E2B (R3) follow-up report.

Here is the scenario:
The Initial PMDA E2B (R3) for company product(A) is submitted.
The case received the follow-up information and this was identified as a duplicate case.
Because of this reason, the nullification report is submitted and
then ACK with ACK number (e.g., ACK001) received.
Note that the company product(A)
still remains in the case.

The case received another follow-up information and the new company product(B) was added.
Initial PMDA E2B (R3) for company product(B) is
submitted with a new safetyreportid.
ACK received with a new ACK
number (e.g., ACK002) for the new safetyreportid.

The case received another follow-up report and the company product(B) was incorrect.
Hence, this product(B) was deleted from the case product tab and
only product(A) exists in this case now.

This case still has the reportable event so the follow-up report for company product(A) is scheduled.

When viewing this follow-up report, old ACK number (ACK001) received for the previous safetyreportid is displayed in J2.1b which is the issue.
In the previous report, the ACK number (ACK002) is received so this ACK number should display in J2.1b.

Due to this, the error ACK with ACK.B.r.7 "20300000510,20300000513" for J2.1b was received after transmitting the follow-up report.

 

Steps:

1. Create a new case
2. Book-in

3. Open the case
4. Go to the product tab and confirm that company product (e.g., PROD(A)) exists
5. Enter the mandatory value for PMDA E2B (R3)
6. Save the case
7. Schedule initial PMDA E2B to Japan MKT license from PROD(A)
8. Lock the case
9. Generate final report
10. Close the case
11. Transmit the report
12. Receive ACK with ACK number (e.g, ACK001)

13. Open the case
14. Go to Analysis > PMDA info tab
15. Confirm that ACK number (ACK001) is populated to Japan MKT license from PROD(A)

16. In the regulatory report tab, schedule the nullification report as duplicate case
17. Generate the final report
18. Close the case
19. Transmit the report
20. Receive ACK

21. Unlock the case as significant info
22. In the product tab, add a new company product (e.g., PROD(B))
23. Enter the mandatory value for PMDA E2B (R3)
24. In the additional info tab, set the previous safetyreportid as E2B Report Duplicate
25. Save the case
26. Schedule initial PMDA E2B to Japan MKT license from PROD(B)
27. Lock the case
28. Generate final report with new safetyreportid
29. Close the case
30. Transmit the report
31. Receive ACK with a new ACK number (e.g, ACK002)

32. Open the case
33. Go to Analysis > PMDA info tab
34. Confirm that ACK number (ACK001) is populated to Japan MKT license from PROD(A) and new ACK number (ACK002) is populated to Japan MKT license from PROD(B)

35. Unlock the case as significant info
36. Delete the PROD(B) in the product tab
37. Save the case

38. Confirm that this case still has the reportable event
39. Schedule the follow-up report to Japan MKT license from PROD(A)
40. View PMDA E2B (R3)

In J2.1b, old ACK number (ACK001) is populated instead of the ACK number (ACK002) that received in the previous report.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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