What is my workflow for setting up a study with multiple periods?

You have to perform many of the same tasks, regardless of whether a study is blinded, open label, or both.

1. Create and schedule all visits, including the visit(s) in which randomization occurs.
2. Define the treatment arms.
3. Create the randomization designs in chronological order (create the first randomization design first, the second randomization design second, and so on).

   Is the study open label, or does it start with an open-label period and doesn't involve randomization? You still have to create a randomization design. The randomization design is how you indicate when the open-label period starts.

4. Add the first and then the second (if it exists) randomization design to the appropriate visits. You have to associate randomization designs with visits in chronological order.

   For the second or higher randomization event in a study, if you chose to map subjects to new treatment arms, the Map Treatment Arms pop-up appears.

5. (If the Map Treatment Arms pop-up appears) Perform the following tasks:
   1. Choose the new treatment arms for subjects:
      • If you map all subjects in a treatment arm to a single treatment arm, subjects aren't randomized.
      • If you map subjects in one treatment arm to 2 different treatment arms, randomization determines their new treatment arm.
   2. Specify the treatment ratio for the treatment arms.
6. Create kit types.