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.