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Listedness Event Has Asterisk Character In Japan PSR Form-3/4 (Doc ID 2659938.1)

Last updated on APRIL 16, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.3 and later
Information 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
Symptoms
Changes
Cause
Solution
References


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