My Oracle Support Banner

TIKEN dialog message does not populate when selecting "Under clinical trial for partial change" category (Doc ID 2597310.1)

Last updated on OCTOBER 11, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.2 and later
Information in this document applies to any platform.

Goal

On v7.x, when selecting the license category "一変治験中(用法・用量/効能・効果の変更/削除)(Under clinical trial for partial change (clinical study for change on indication/listedness)" in case form > analysis > PMDA info tab,
the following warning message appeared so that the end-user was able to confirm if the text "TIKEN" has been configured in the product note field.

Message:
"一変治験中(用法・用量/効能・効果の変更/削除)”が選択されたので、文字列“TIKEN”が"症例フォーム/製品/ノート”に入力される必要があります。
(“Under clinical trial for partial change (clinical study for change on indication/listedness)” has been selected, so “TIKEN” needs to be entered in the “Caseform/Product/Note”.)

 

On v8.1 or a higher version, this warning message no longer populates when selecting this license category.
According to PMDA regulation, the text "TIKEN" must populate in G.k.11(B.4.k.19) for the Japan INV license.
Why does this warning message no longer appear?



Steps:
1. Go to the Analysis tab > PMDA Info tab.
2. In the "Suspect Product License Information" section, select the license category "一変治験中(用法・用量/効能・効果の変更/削除)(Under clinical trial for partial change (clinical study for change on indication/listedness)"

No warning message pops-up.
 

Solution

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!


In this Document
Goal
Solution
References


My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.