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Summary

In recent ClinSpark releases, various features were introduced to better support blinding of Study Data. Starting with May 2024 version, data can also be blinded in the Transfer Data report.

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  1. Blind the Data in the User Interface.

  2. Add the “Blind Reports” Alias to an Item Group in your Forms Library.

  3. Add additional Aliases for each Role that should have unblinded access.

Blinding Data in the User Interface

There are existing mechanisms in ClinSpark that allow the blinding of Data in the User Interface. Read more by clicking on the links below:

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The data needs to be blinded in the UI, in order for it to be blinded in the Transfer Data report.

Adding Aliases

If the Transfer Data report needs to be blinded (for some or all users), you will need to create a dedicated form with an Item Group and an Alias to control this.

  • In CRF Design > Study Library > Forms Library, create a Form with a name that would easily allow you to identify it. The naming is flexible, you could call it “Study Blinding” for example. The name of the Form does not impact the downstream process.

  • Within the Form, create an Item Group, the naming is flexible once again, it could be called “Study Blinding”, just like the Form.

  • The Item Group does not need to contain any actual Items. The important part of the setup is in the Item Group Aliases section.

    • Add Alias with Name “Blind” and Context “Blind Reports”

    • Add an Alias for each Role you wish to grant unblinded access to: Name “Unblind Role”, Context “The exact name of the Role”. The name of the Role needs to match exactly an existing Role in Administration > Roles.

  • The Form does not need to be locked at any point. This will make it easy to go in and edit unblinded Roles or remove the blinding as appropriate.

Example Blinding Item Group

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Unblinding

At the time, when it is appropriate to unblind the Transfer Data report, you may simply delete the “Blind” Alias that you had previously added. This will remove all blinding requirements from the report.

Visual Summary

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