To associate a randomization or minimization design with a visit, just drag the design to the visit.

1. Access the Draft version of a study as described in Open a study's design.
2. Along the top, select Study Supplies.
3. Make sure the Randomizations tab is selected.
4. On the Visits & Events pane, locate the scheduled visit the study protocol defines as the randomization event.
5. On the left, identify the randomization design to assign to a visit:

   Note:

   For any randomization event, make sure the randomization design is appropriately blinded or unblinded.
   • If you're assigning the first randomization event in the study, make sure the randomization design doesn't say Re-Randomization on it.
   • If you're assigning the second or later randomization event in the study, make sure the randomization design is for Re-Randomization.
6. Drag the randomization design to the visit.

   Note:

   An error occurs if you try to add a randomization design before another randomization design, so you must drag the randomization designs to the visit schedule in chronological order. Drag the first randomization design, then the second randomization design, and so on.
   A blue line appears between the randomization event and the next scheduled visit, and the randomization design displays the visit you assigned it to.
7. If you just dragged the first randomization design in the study to a visit: You have finished assigning the randomization design to the visit.
   An eye appears on the visit if the randomization design is unblinded.
8. If you dragged a second or later re-randomization design in the study to a visit, you must follow these extra steps if the re-randomization design requires that subjects be mapped to new treatment arms:
   The Map Treatment Arms dialog appears so you can choose the treatment arms that subjects should move to. You can map subjects from one treatment arm to the same treatment arm, a different treatment arm, or multiple treatment arms. If you map all subjects in one treatment arm to a single other treatment arm, either the same or different, those subjects aren't randomized again.
   1. On the right, check whether all treatment arms that you'll use after this randomization event are present.

      Note:

      Any new treatment arms that are in the second but not the first randomization design don't appear. To add a treatment arm, select the plus sign in the upper-right corner, and select the treatment arm(s) to include.
   2. On the left, locate the treatment arm that subjects are currently in and then choose the subjects' new treatment arm by dragging the treatment arm to the appropriate treatment arm on the right.
   3. In the Ratio fields for each treatment arm, enter whole numbers for the new treatment ratio.
   4. Select Map Treatment Arms.
      Green background shading appears for the second randomization visit and subsequent visits, and yellow appears for the third randomization visit.
9. To remove a randomization design you assigned to the wrong visit, select the visit in Visits & Events, and then select the trash can on the randomization design.

   If you remove a randomization design from a visit, any subsequent randomization designs are also removed.

   If you change the visit when randomization occurs, if necessary. For step-by-step instructions, see Define the dispensation schedule.

10. To edit the way that subjects are mapped to new treatment arms after the second or later randomization event, select Map Treatment Arms to the right of the visit.