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PMDA tab shows Unmatched Trade Name and License Combination for Unblinded Study (Doc ID 1385371.1)

Last updated on AUGUST 16, 2019

Applies to:

Oracle Argus Safety Japan - Version 6.0.2 and later
Information in this document applies to any platform.


When a Product has multiple Licenses for Japan, in a Case with an
Unblinded or Non-blinded Study, and the 'Study Drug' is specified on the
Product tab of the case form,
Case Form >> Analysis >> PMDA Info >> General >> [Suspected product
license info] block shows the Default Trade Name for all licenses with
different license#.

For example, [Suspected product license info] block shows;
TN001 (LI001)
TN001 (LI002)
TN001 (LI003)

The Product License has the following definition:
Trade name=TN001, License#=LI001
Trade name=TN002, License#=LI002
Trade name=TN003, License#=LI003

Users will confuse as if the system would be recognizing the Product
License information incorrectly.


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