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Existing SAFETYREPORTID Was Assigned To Initial PMDA E2B R3 (INV) (Doc ID 2791208.1)

Last updated on AUGUST 05, 2021

Applies to:

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

Symptoms

Issue:

The existing SAFETYREPORTID was assigned to the newly scheduled initial PMDA E2B (R3) INV.

 

Scenario #1: Delete the product / license from case product tab and add it again

Conditions:

a) Codelist : reporting destination > EDI tab
The flag "Allow multiple reports for Investigational Drugs" is checked.

b) The case has the following product with Japan licenses.
- Product(A) has JPN MKT license (001) and JPN INV license (002)
- Product(B) has JPN INV license (003)

Steps:

1. Create a new case
2. book-in
3. Enter the mandatory information for PMDA E2B (R3)

4. Auto-schedule initial PMDA E2B (R3) to Japan Investigational license INV-003 for Product(B)
5. In the regulatory report tab, generate the final report by clicking the final link. Confirm that SAFETYREPORTID is set as xx-xxx-xxxAA (Suffix is AA)

6. Auto-schedule initial PMDA E2B (R3) to Japan Marketed license MKT-001 for Product(A)
7. In the regulatory report tab, generate the final report by clicking the final link. Confirm that SAFETYREPORTID is set as xx-xxx-xxxAB (Suffix is AB)

8. Close the case
9. Transmit and submit both reports
10. Import ACK

11. Open the case
12. Go to Analysis > PMDA info tab
13. Confirm that PMDA ACK number displays
14. Go to regulatory report tab
15. Confirm that report status shows as Submitted

16. Unlock the case
17. Delete and add the same product/license
18. Enter the mandatory value for PMDA E2B R3
19. Save the case

20. Go to regulatory report tab
21. Press the [Auto-Schedule] button
22. Confirm that the follow-up #1 PMDA E2B (R3) was scheduled to Japan Investigational license INV-003

23. In the regulatory report tab, generate the final report by clicking the final link. Confirm that SAFETYREPORTID shows as xx-xxx-xxxAA (Suffix is AA)

24. Close the case
25. Transmit and submit the report
26. Import ACK


27. Open the case
28. Press the [Auto-Schedule] button if the initial PMDA E2B (R3) to Japan Investigational license INV-002 for Product(A) has not been scheduled after step19

29. Click the draft link


SAFETYREPORTID shows as xx-xxx-xxxAB (Suffix is AB)

System should ideally assign AC for the sequence for the 3rd license.

 

Scenario #2: Change the report type to (e.g.,) spontaneous and change back it again

Conditions:

a) Codelist : reporting destination > EDI tab
The flag "Allow multiple reports for Investigational Drugs" is checked.

b) Study(A) has 3 study products at least and each product has Japan INV license.

Steps:

1. Create a new study case with Study(A) and select the report type as "Sponsored Trial" for example.
2. book-in

3. Open the case
4. In the product tab, select the study drug as PRODUCT(001)
5. Enter the mandatory information for PMDA E2B (R3)

--- 1st Japan INV license
6. Schedule initial PMDA E2B to JPN-INV-001 license
7. Lock the case
8. Generate the final report and confirm that SAFETYREPORTID is set as xx-xxx-xxxAA (Suffix : AA)
9. Close the case, transmit and submit the report

10. Unlock the case
11. Change the report type to "Spontaneous" and change back to the original report type "Sponsored Trial" again
12. Select the Study(A) in the general tab
13. In the product tab, delete the 1st tab which is non-study product
14. Select the study drug as PRODUCT(001)
15. Add the study product and select the study drug as PRODUCT(002)
16. Add the study product and select the study drug as PORDUCT(003)
17. Enter the mandatory value for PMDA E2B (R3)
18. Lock the case

--- 2nd Japan INV license
19. Schedule initial PMDA E2B to JPN-INV-002 license
20. Generate the final report and confirm that SAFETYREPORTID is set as xx-xxx-xxxAB (Suffix : AB)
21. Close the case, transmit and submit the report

--- 1st Japan INV license
22. Schedule follow-up#1 PMDA E2B to JPN-INV-001 license
23. Generate the final report and confirm that SAFETYREPORTID is set as xx-xxx-xxxAA (Suffix : AA)
24. Close the case, transmit and submit the report

--- 3rd Japan INV license
25. Schedule initial PMDA E2B to JPN-INV-003 license
26. Generate the final report and confirm that SAFETYREPORTID is set as xx-xxx-xxxAB (Suffix : AB)

System should ideally assign AC for the sequence for the 3rd license.

Cause

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In this Document
Symptoms
Cause
Solution
References


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