Erroneous Study Drug ‘Substance Name, Strength And Unit’ Details After Case Unblinding

(Doc ID 2407107.1)

Last updated on JUNE 20, 2018

Applies to:

Oracle Argus Safety - Version 8.1.1 and later
Information in this document applies to any platform.

Symptoms

Oracle Argus Safety Version : 8.1.1 and later

Incorrect Study Drug ‘Substance Name, Strength and Unit’ details are displayed after Case Unblinding

Substance Name details of Study Drug are not consistent with Study Drug Ingredients.

For blinded studies with multiple study drugs configured in the study, Blinded case shows Substance Name details from first Study Drug configured in Argus Console for the study.

Upon unblinding and selecting a study drug that is not the first study drug configured in the study, the Substance Name details are added to the details already present instead of being substituted.


 The issue can be reproduced at will with the following steps.

 

 

 

Changes

 

Cause

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