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Additional Study Drug Getting Added After Importing Follow-up ICSR (Doc ID 2758723.1)

Last updated on MARCH 15, 2021

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

Issue:

In the each follow-up import of ICSR (R3), another study drug product tab was added in the case product tab.

This is not expected behavior.

Since the study product tab already exists in the case product tab, another study drug product tab should not add after importing the follow-up ICSR.

 

Steps to replicate the issue:

1. Import and accept initial ICSR (R3) xml file which contains the study information

2. Open the case

3. Go to the product tab.

Confirm that only one study product tab populates in the case product tab.


 

 

4. Close the case without the saving

5. Make a copy of initial ICSR (R3) xml as follow-up ICSR and update minor changes (e.g, messagenumb etc)

6. Import and accept follow-up ICSR (R3) xml file

7. Open the case again

8. Go to the product tab.

Confirm that additional follow-up study product tab populates in the case product tab.

Note that 1st study product tab and 2nd study product tab are not linked so it doesn't shows as like "#1 of 2 Study Drugs" and #2 of 2 Study Drugs".

Cause

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In this Document
Symptoms
Cause
Solution
References


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