Different safetyreportid was assigned for PMDA E2B downgrade report (Doc ID 2226956.1)

Last updated on MARCH 01, 2017

Applies to:

Oracle Argus Safety Japan - Version 7.0.7 and later
Information in this document applies to any platform.

Symptoms

The PMDA E2B for Japan investigational(INV) license has been submitted from the study case.

By the follow-up information, the study drug which includes this INV license was deleted from case product tab.

Then, the same study product was added again to the product tab and set the event/assessment information for this license.

By the auto-scheduling, the follow-up (downgrade) report was scheduled which is correct.

However, it is not the same safetyreportid (A.1.0.1) as the previous report.

 


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STEPS
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1. Create a study case
2. Set the study which has more than two company products
3. Enter the mandatory value and book-in

4. Go to the product tab
5. Select the study product(A)
6. Add the study product
7. Select the study product(B)
8. Enter the mandatory value for PMDA E2B
9. Press the [Auto schedule] button
10. The initial PMDA E2B for INV license from product(A) was scheduled
11. Lock the case and generate the final report

For example:
<safetyreport>
<safetyreportversion>1</safetyreportversion>
<safetyreportid>JP-ORACLE-16JP000340AA</safetyreportid>

 

12. Submit and transmit the initial report
13. Receive ACK

14. Open the case
15. Unlock the case as significant info
16. Go to the product tab
17. Delete the study product(A)
18. Save the case

19. Add the study drug
20. Select the study product(A) again
21. Go to the event assessment tab
22. Set the reportable as NONE in order to schedule downgrade report later
23. Save the case

24. Go to the analysis tab > PMDA Info
25. Since the original report (prod_seq_num) has been deleted, re-enter the E2B J elements information
26. Save the case

27. Go the regulatory reports tab
28. Press the [Auto schedule] button
29. PMDA E2B f/u (downgrade) for INV license from product(A) was scheduled
30. Lock the case and generate final report.

Check the value of A.1.0.1.

For example:
<safetyreport>
<safetyreportversion>2</safetyreportversion>
<safetyreportid>JP-ORACLE-16JP000340AB</safetyreportid>

 

The different safetyreportid has been assigned.

Cause

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