Advanced Condition Does Not Protect User From Unblinding Information - Is This Expected? (Doc ID 3040566.1)

Last updated on AUGUST 12, 2024

Applies to:

Symptoms

If a user creates an Advanced Condition to search for a specific Study Drug, this will return all cases that have that Study Product selected.

However, it will also include Cases for an unblinded study when the user running the query has 'Protect from unblinded information' and the study has "study is eligible for Unblinding" unchecked.

This will then reveal to the user the unblinded product cases, although when this same user opens the said case all fields are marked as Blinded to the user.

To reproduce:

• Create a Blinded Study [Argus Console] > [Business Configuration] > Studies with 'Study Product A' and 'Study Product B' both company products, both products are blinded (Double-Blind).
• Ensure The "study is eligible for Unblinding" checkbox is unchecked

• Create or utilize a user that has 'Protect from unblinded information' checked [Argus Console] > [Access Management] > Users:

• Create an Advanced Condition that searches for one of the unblinded study products i.e. 'Study Product A'.
• Create a case for the study and as a full access user unblind the case and select 'Study Product A' as the Study drug administered.
• As the full access user if you run the AC this case is then returned, and all data is visible.
• Log in as the new user with 'Protect from unblinded information' checked in their user account
• If they open the unblinded case, then all fields are marked as Blinded, so they are correctly unable to see the study's unblinded product-related data.
• However, if they run the AC created in an earlier step for the study drug - 'Study Product A', then this case is returned effectively revealing the unblind to a user that has 'Protect from unblinded information' checked.

Cause

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