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Last Record Removed From Event--> Event Assessment For 'Not Blinded' Studies (Doc ID 2767167.1)

Last updated on AUGUST 12, 2021

Applies to:

Oracle Argus Safety - Version 8.2.2 and later
Information in this document applies to any platform.

Symptoms

On Argus Study Cases with the following conditions:

1) Study Type is set to 'Not Blinded'
2) Contain multiple study products (and include a product without a license configured)

When initially coded to the case, the secondary product and link to the coded Event Terms appear on the event assessment tab allowing causality to be entered.

However when the user closes the application and logs back in to open the case, the event assessment linked to the product which is not related to a
license will disappear.

The case saves correctly and represents data within the audit trail.

Steps to Reproduce

1)Configure a 'Not Blinded' study with two company study drugs,
  Study drug 1 contains a drug with a configured license
  Study drug 2 is not linked to any license




2)Bookin a case to the new study and select study drug 1, then right click and add study drug 2 as a new tab.

 

3)Navigate to the Event assessment tab and populate causality for both drugs.



4)Save case.


5)Close case and log out of the Argus Application.

6)Log back into the Application and open up the case booked in and navigate to the Event Assessment.
  The second record linked to study record 2 is missing.

Cause

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In this Document
Symptoms
Cause
Solution
References


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