CCN and Target Disease are made NULL when Study is Updated by E-user

(Doc ID 2105525.1)

Last updated on MARCH 11, 2017

Applies to:

Oracle Argus Safety Japan - Version 7.0.4 and later
Information in this document applies to any platform.

Symptoms

PROBLEM DESCRIPTION:
----------------------------
When an existing Study is having values in the following J-fields on Argus Console, if E-user updates the Study for any parts, the J-fields value are cleared to NULL behind the scene.

J-FIELDS:
---------------
--治験成分記号.............English Translation: Clinical Compound Number
--対象疾患 (使用理由)....English Translation: Target Disease Indication
--投薬中の症例の有無.....English Translation: Are any subjects given this investigational drug?

PATH TO OPEN THE SCREEN FOR THE J-FIELDS:
-----------------------------------------------
Argus Console >> Business Configuration >> Studies >> (Study-ID) >> [J Data Entry] button.

CONDITION THIS ISSUE HAPPENS:
----------------------------------
This issue occurs when Study is updated by E-user (UserType = ARGUS USER).
This issue does not occur when Study is updated by J-user (UserType = ARGUS J USER).

E-FIELDS AFFECTING TO J-FIELDS IF UPDATED:
-----------------------------------------------
The following parts of Study have been confirmed to raise this issue for the J-fields if that part is updated by E-user.
--Study Development Phase
--Product License
--Products
--Clinical Reference
--Study Centers
--Study Description
--Country
These seem to be the affection happens at any English screen parts if it is updated by E-user.

HOW TO REPEAT:
---------------------
1)Login to application by J-user.
2)Create a Study on Argus Console.
Set J-fields for
--Clinical Compound Number = <proper number>
--Target Disease Indication = <J-Headache>
--Are any subjects given this investigational drug? (Yes/No) = <J-Yes>
Save the study.
3)Logout from and login to application by E-user.
4)Open the same Study on Argus Console.
Update any part of the Study.
For example, add a record to [Clinical References] block.
Save the study.
5)Logout from and login to application by J-user.
6)Open the same Study on Argus Console.
Open J-fields screen.
--->
--Clinical Compound Number = NULL
--Target Disease Indication = NULL
--Are any subjects given this investigational drug? (Yes/No) = NULL




Cause

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