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Case Appears on PSR Form-4 After Case Report Is Nullified (Doc ID 2461164.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.

Symptoms

Case appears on PSR Form-4 After the case report is Nullified.

Steps to Repeat:
----------------
1) Bookin a case.
2) Enter necessary information.
3) Auto-schedule I.C.S.R R3 for PMDA.
4) Generate report and check values for G.k.2.2 and G.k.2.3.r.1
5) Receive ack.
6) Unlock case as significant follow-up.
7) Re-select case product to change the license from JP to world.
8) Auto-schedule nullification report.
9) Open and confirm that G.k.2.2 and G.k.2.3.r.1 values are different from the values in step 3) due to the operations in step 7)
10) Submit nullification
11) Generate the Periodic Report for the product and confirm the case is still getting exported despite of the nullification report

 

Cause

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In this Document
Symptoms
Cause
Solution
References


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