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Final link of PMDA R3 Nullification is disabled on locked case (Doc ID 2532482.1)

Last updated on AUGUST 28, 2019

Applies to:

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

Symptoms

Final link of PMDA R3 Nullification is disabled on locked case.

As the result, Nullification cannot be submitted.
A case product was deleted from the case.
License of the deleted product is the license to which the previous PMDA R3 ICSR was scheduled for and submitted.

1) E user create a new foreign case. Case has 2 products, Product-A has US and JP licenses and Product-B has US license only.
2) E user enters data for the case and submit ICSR R2 for FDA.
3) E user passes the case to J user.
4) J user enters data for the case and submit ICSR R3 for PMDA.
5) J user passes the case to E user.
6) E user removes Product-A from the case and update case data.
7) E user passes the case to J user.
8) J user manually schedules Nullification by right mouse button click menu for the submitted ICSR R3 for PMDA.
9) J user clicks Draft link of the Nullification. ICSR Viewer is opened.
10) J user locks the case. ---> Final link of the Nullification is still disabled.

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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