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Incorrect Product Case Information is Included in JPSR Form 3 (Doc ID 2766278.1)

Last updated on APRIL 06, 2021

Applies to:

Oracle Argus Safety Japan - Version 8.2.2 and later
Information in this document applies to any platform.

Symptoms

When Product A having 2 licenses for example License 1 is investigational and License 2 is marketed,
then License 2 is link from Product A to Product B, a date will populate in LM_LIC_PRODUCTS table in DELETED column.
A case with Product A and B and a PMDA report is submitted for License 2.
When PSR is generated for Product A only, the case is still been include in the PSR.

Steps to Reproduce:

1. On Argus Console, create Product-A.
--License-1 (INV)
--License-2 (MKT)

2. On Argus Console, create Product-B.

3. On Argus Console, change License-2 (MKT) link from Product-A to Product-B. Do not delete License-2.

Product-A
--License-1 (INV)

Product-B
--License-2 (MKT)

4. Confirm the LM_LIC_PRODUCTS table record for the Product-A and Product-B PRODUCT_ID, LICENSE_ID, and DELETED columns will have values like below:
Product-A-ID, License-1-ID, NULL
Product-A-ID, License-2-ID, <date>
Product-B-ID, License-2-ID, NULL

5. Create a new case with Product-A and Product-B, and submit PMDA report for License-2 (MKT).

6. Create a new PSR with configurations like below:
-- Product = only Product-A
-- Timeframe includes the submitted report

7. Print the PSR draft.

8. The case is included in the PSR Form 3.

 

Cause

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In this Document
Symptoms
Cause
Solution
References


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