Randomization occurs when a form that is defined in a visit that is also defined as a randomization trigger, is saved with no errors. If the form contains errors, the randomization will not occur. Once the form is clean and in a Green Check status, that form will randomize.

 

Once a subject is randomized the following two events occur:

 

        1. The Randomization table is updated (see View and Decode the Randomization File).

 

        2. A confirmation email is sent to all those in the randomization distribution list.

Optionally, when a form is saved, the system will show the user the randomization allocation. In that case, the randomization was unblinded. That is defined in the Create Randomization form and described at the beginning of this document. When the randomization is unblinded, the allocation will be shown in the form’s Save Form Messages window that is displayed after each form is saved as shown in the figure below.

To retrieve an existing unblinded randomization allocation, you can either access the View Randomization app or resave the form. When resaving the form, if a unblinded randomization is defined for that form, it will also be displayed in the Save Form Messages window as shown in the figure below.