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J2.4.k Is Not Populated For Nullification Report (Doc ID 2423272.1)

Last updated on JULY 13, 2023

Applies to:

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

Symptoms

J2.4.k is not populated for nullification report when the case product license was changed from JP to other country.

 

HOW TO REPEAT:
----------------------
1) Bookin a case.
2) Enter necessary information.
3) Auto-schedule I.C.S.R R3 for PMDA.
4) Generate report and submit to PMDA. J2.4.k element exists in ICSR.
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 nullification by clicking Draft link.
--->
J2.4.k element is missing.

 

The issue also happens in the scenario which previous report was submitted as R2 and nullification is generate as R3.

HOW TO REPEAT:
----------------------
1) Book in a case.
2) Enter necessary information.
3) Auto-schedule I.C.S.R R2 for P M D A.
4) Generate report and submit to P M D A.
5) Unlock case as significant follow-up.
6) Re-select case product to change the license from Japan to another country.
7) Check there is no Japan license in the P M D A Info tab
8) Change the message profile to P M D A R3 in the reporting destination settings.
9) Auto-schedule nullification report.
10) Open nullification by clicking Draft link --> J2.4.k element is missing.

 

Cause

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In this Document
Symptoms
Cause
Solution
References


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