Summary

This article covers how to enable emergency unblinding.

Table of Contents

If a subject experiences a serious adverse event that requires them to know the details of their drug assignments, emergency unblinding may be needed. Standard unblinding can also occur at the end of the study phase. If the unblinded form is made available, it will display the Treatment Type, Drug Type, the person responsible for the unblinding and the date that the unblinding occurred on.

Add Forms

To allow for unblinding, two forms must be created. The first form is the form that must be filled out to enable emergency unblinding. The second form is the form that will contain the unblinded information and be viewed by unblinded subjects.

  1. On the ‘Forms – Template’ worksheet, create an emergency unblind form.
  2. On the ‘Forms – Template’ worksheet, create a form to contain the unblinded information.


Note: The unblinded information form must have a formTypeId of ‘exposeDTRT’ for unblinding to work.


  1. Add the two new forms to the ‘Form Types – Definition’ worksheet.


Add Questions

Questions need to be created for the emergency unblind form.

  1. Add the unblinding questions to the ‘Question Types – Definition’ worksheet.
    • These questions should be answered correctly to unblind a subject.
  2. Add each unblinding question to the ‘Question Layout – Template’ worksheet.
  3. Add form display information to the Display worksheet for the emergency unblinding form.

Configure Roles and Branching

  1. Add ‘exposeDTRT’ as a ‘Screens Required’ permission to the Roles worksheet.
  2. Add the emergency unblinding form to the Branches worksheet.
Note: Creating the form through scripting can also be used to trigger the creation of the unblinding form. However, scripting offers little control over forwarding, so the system will not automatically display the unblinded form after the event is triggered. Instead, you will have to navigate to the unblinded form manually.

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