Replace randomization for subjects

If a subject has been withdrawn from a study, you can replace them with a new subject that is assigned to the same treatment arm.

Before you work with this feature

Be aware of the following:
  • Only users with the Replace Randomization permission can perform replacement and view a replacement randomization.
  • Once a subject's randomization has been replaced, the option to undo withdrawal is not available.
  1. Access your study in a specific mode
  2. Along the top, select Subjects.
  3. If you have access to multiple sites for the study, from the Site filter, select a specific site.
  4. In the table, select the checkbox next to the subject you'd like to replace the randomization for.
  5. Above the table of subjects, from the Manage drop-down, select Replace Randomization Number.
  6. In the Confirmation dialog, select Yes.
    The subject's status updates to Withdraw / Rand Replaced in the Subjects list, and Replacement Randomization is displayed on the Subject History sidebar.