Listedness Event Has Asterisk Character In Japan PSR Form-3/4
(Doc ID 2659938.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.1.3 and laterInformation in this document applies to any platform.
Symptoms
Issue:
There is a case which has the listed event for Japan license.
In PSR report template, the product for this Japan license is configured as PSR product.
When printing the PSR form-3/4, the event is populated with the asterisk character even though this is listed event.
Steps to Repeat:
In Argus Console > Product / license configurations:
- Prod-A has Japan license (JP-001)
- Prod-B has Japan license (JP-002) and Japan license (JP-001 from Prod-A)
Steps:
1. Go to case action > new and create a new case with JP-001 license from the "Prod-A"
2. Enter the mandatory information for book-in
3. Book-in
4. Open the case
5. Go to the product tab > new tab
6. Add Japan license (JP-002) license from the "Prod-B"
7. Go to the event assessment tab
8. Set the listedness information as follows:
JP-001 from Prod-A : Unlisted
JP-001 from Prod-B : Listed
JP-002 from Prod-B : Listed
9. Enter the mandatory information for PMDA E2B (R3)
10. Schedule PMDA E2B (R3) to the Japan license (JP-002) license from the "Prod-B"
11. Lock the case
12. Generate the final report
13. Submit the report and receive ACK (Confirm that report status is set as Submitted).
14. Go to Reports > Periodic > PSR/ReSD
15. Create a new PSR form-3/4 and select "Prod-B" as PSR product
16. Save the report template
17. Print out this report
18. View the report
The event is populated with the asterisk(*) characters event though the Japan license from Prod-B is the listed event.
Note: As regulation, the asterisk(*) characters will add to a unlisted event.
Changes
Cause
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In this Document
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Cause |
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