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.
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
For example, [Suspected product license info] block shows;
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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