9 Randomization and treatment arms

To put together a proper randomization design, you must first create treatment arms and then define the details of the appropriate randomization design for your study.

• Define a treatment arm
  If a treatment arm is used in both a blinded and open-label period, create just one treatment arm for both study periods. The unblinding setting on the randomization design determines whether the treatment arm title is visible to blinded users.
• Define the randomization
  Create a randomization design either to specify randomization details or to start an open-label period, even if the open-label period doesn't have a randomization event.
• Define the minimization
  Create a minimization design to balance the number and characteristics of subjects across treatment arms.
• Add randomization to a visit
  To associate a randomization or minimization design with a visit, just drag the design to the visit.