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.
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.
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