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Expected Case Not Appear in J-NUPR/NSULL Periodic Report Even Though it Meets the J-NUPR/NSULL Inclusion Criteria (Doc ID 2816081.1)

Last updated on AUGUST 08, 2022

Applies to:

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

Symptoms

Expected case not appear in J-NUPR (Japan non-serious unlisted periodic report) / NSULL (Non-serious unlisted line listing) periodic report event though it meets the J-NUPR/NSULL inclusion criteria.

As per PMDA regulatory, when the case event meets J-NUPR/NSULL criteria (i.e., Non-serious/Unlisted/Related), it is expected to be include in J-NUPR/NSULL report even though it is not reportable to PMDA.

Steps to reproduce:

1) Create Japan spontaneous case with product having world license
2) Enter an event which is non-serious, unlisted & related
3) Schedule and generate CIOMS-I report
4) Submit the report
5) Create a J-NUPR/NSULL report with above world license product configured under product tab
6) Set the scheduling period/timeframe to synchronize with the case received date
7) Generate J-NUPR/NSULL report
8) The target case is not included in the generated report



Cause

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In this Document
Symptoms
Cause
Solution
References


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