How to randomize a subject

Learn how to perform randomization, thus allocating a subject to a defined subgroup.

When the randomization is configured for a study, a subject can be randomized by opening the eCRF (scheduled events) of the respective subject.

On the top right, the randomization button will be visible which indicates whether a subject is ready to be randomized. If stratification variables are set, these stratification fields must be filled before randomization can be performed. If there are data inputs missing, a hover over the disabled button will provide additional information.

Once the randomization button is available and active, click on "Randomize subject". Relevant stratification information will be displayed (if configured) and the user needs to confirm the action by clicking "Randomize". Beware, that the randomization cannot be reverted once the action was performed for the subject. Also, values entered to stratification variables cannot be updated any longer. These fields will be disabled. If sites are used for stratification, switching the site for a subject will not be possible anymore. Once the randomization is confirmed and allocation was successful, the top right button will change to "Randomization done" and upon click all details can be viewed.

2. Subject Overview

In the subject overview you can find all relevant details about the randomization. Learn more here: Subject overview in a study

⭐ Good to know: If you only see a tick in the Subject Overview, but not the group assignment, this means that you have been blinded for this study. Randomisation reading rights are defined in the Access Management of the study. If you think you need to see the randomisation group, please contact your study coordinator.

In the section "Subject Management" of the filter widget it is possible to filter the subject overview for the randomization details (Learn more here: How to filter with the filter widget)

3. Access Rights

Depending on the rights assigned to your role you can either read the randomization details, incl. the assigned randomization group, who performed the randomization action (randomized by) and at what timestamp (randomized at), and/or perform the randomization action yourself. If you do not see the randomisation button but should be able to perform this function, please contact your study coordinator.