Add randomization to a visit

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

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.

In the following example, subjects in the 10 mg dose and 5 mg dose arms remain in their treatment arms and aren't randomized again. Subjects in the Placebo arm are randomized to determine whether they move to the 5 mg dose or 10 mg dose arms.

Want to see how to perform this task? Watch the video below.

You must create a randomization or minimization design first.

For step-by-step instructions, see Define the randomization or Define the minimization.

Note:

The visit that is assigned a randomization design must be required and scheduled, and it cannot be the study completion, withdrawal, an unscheduled visit, or event.

To add randomization or minimization design to a visit:

1. Access the Draft version of a study as described in Open a study's design.
2. Along the top, click 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.

   Tip:

   A scheduled visit has a blue clock leading into it; a visit that has not been scheduled yet has a gray clock.
5. On the left, identify the randomization design to assign to a visit:
   • 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.
   • For any randomization event, make sure the randomization design is appropriately blinded or unblinded.
6. Drag the randomization design to the visit.

   Tip:

   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. Depending on what your previous step was, you have two options:
   • If you just dragged the first randomization design in the study to a visit: You have finished assigning the randomization design to the visit. Blue background shading appears behind visits that are prior to randomization and behind unscheduled visits, and orange appears behind the first randomization visit and subsequent visits. Additionally, an eye icon () appears on the visit if the randomization design is unblinded.
   • If you dragged the second or later randomization design in the study to a visit: If the 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.
8. If you used a second or later randomization design to a visit, you must follow these steps next:
   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, click 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. Click 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, click the visit in Visits & Events, and click 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, click Map Treatment Arms () to the right of the visit.