Randomize a participant in EDC/CDMS
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To be able to randomize participants, randomization must have been first enabled and set up. See Randomization settings for further information on how to set up the randomization for your study. We also have a workshop video on how to randomize a participant.
Open a participant (that needs to be randomized)
Once you have set up your randomization, you can start randomizing participants. In the participants tab, click on the participant you want to randomize.You can also double-click the participant to enter it. If you have not yet created a participant, learn how to do that here.
Randomize the participant
Once in the participant view, select the 'Randomization' tab from the left menu
Click the "Randomize" button to randomize the participant. When you have configured randomization that is stratified on one of the data points (fields) in your study, you will see those fields listed in the bottom grid. You can only randomize your participant after all fields that are used for stratification have been completed. For easy access to the set field you can click the eye next to it.
After randomizing a pop-up will ask you to confirm the randomization. After randomizing the participant this cannot be undone.
The randomization tab now shows the randomization group and the randomization number and other relevant information. This tab will not be available for users without randomization rights:
The randomization number is the position of this randomized participant in each randomization group. So the first participant to be randomized in one group will always have randomization number 001, and the second 002 etc.
The randomization group is also visible in the participant overview. This will not be visible for study users without randomization rights (which allows for blinding) - the group will be shown as 'Hidden'.
When a participant has been randomized, it is no longer possible to change the data for a field or its parent if it has been used for stratification.