Unblinding Subjects

Unblinding Subjects


1. How to perform an emergency unblinding


The following procedures must be followed:

1. Go to Codes page (button in Welcome page or in the dropdown menu at the left of the page) 


2. Click on the red button Unblind in the corresponding subject's entry


3. Confirm Subject Code (randomisation code) and the Reason for unblinding

Note: in case the information you entered is incorrect or incomplete, a warning will be shown.


4. If the information is correct click Unblind and then Confirm if you want to proceed

5. When information is correctly provided a confirmation is required for unblinding to proceed


6. Unblinding information will be shown in case you confirmed the unblinding.


7. The list of Unblinded subjects is also available in Unblinded Subjects page (if you have the permission to see unblinding information).




2. Predefined unblinding reasons


Trials can also be configured to have a set of predefined reasons for unblinding and free text field for additional information. Select a reason from predefined list is mandatory.


Additional information can also be added.


The list of unblinded subjects will include both the reason and the additional information (if any was added when unblinding subject).


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