Understand how visit branches work

Adding visit branches gives you better control over your subject visit schedule and allows you to customize schedules for a specific cohort or multiple treatment arms. Before designing with branches, you should understand how they work.

Think of a visit branch as a grouping of visits within the visit schedule. A branch can also be cycled. That is, all visits in that branch can be repeated for n number of cycles, depending on your study design.

Branches can be customized to fit the needs of your study. For example, you can create different visit schedules when dispensation and visits vary based on the treatment arm that the subject is assigned to. You can collect additional data during specific visits for only a subset of subjects. You can also include additional visits both before and after the branch completes.

While assigning subjects to a visit branch based on treatment arms may be a more common scenario, you can also assign subjects to a visit branch based on their answer to a certain question.

If you choose to assign subjects to a visit branch based on form data, remember that when the initial visit schedule includes intermediary visits between the visit in which the form is answered and the branch, a site user must skip these intermediary visits prior to moving the subject onto the visit branch. For instance, if a visit schedule includes Screening visit, Week 1 visit, Week 2 visit and two new branches (Branch 1 and Branch 2) and the form question that launches Branch 1 is in Week 1, when a subject gives the expected answer to this question, a site user must skip the Week 2 visit, so the subject can begin their visits in Branch 1.

To help understand the workflow for creating branches, let's take a simple example. In this example, you have already created two scheduled visits that apply to all subjects, a screening visit followed by a randomization visit, for an oncology study. After the randomization visit, you want subjects to be scheduled using branches based on the treatment arm to which they are assigned. For simplicity, we'll call these Treatment Arm A and Treatment Arm B. The branch visits will cycle every 28 days for 24 cycles (over a period of two years). Once the treatment completes, you want all subjects to be scheduled for a series of follow up visits. The study ends with a study completion visit for all subjects.

The branch details are summarized as follows:

Branch Assign Subjects Using Cycles Count of Cycles
Branch A Treatment Arm A Yes 24
Branch B Treatment Arm B Yes 24
Follow Up
  • Treatment Arm A
  • Treatment Arm B
Yes Unlimited

To create these branches as described, your overall workflow would look similar to the following:

  1. Create your screening and randomization visits. See Create a visit or event.
  2. Create Branch A. See Create a visit branch.
  3. Add your scheduled visits to Branch A. See Add a scheduled visit to a branch.
  4. Set the visit schedule and add cycling information for Branch A. See Define the visit schedule for a branch.
  5. Create Branch B. See Create a visit branch.
  6. Add your scheduled visits to Branch B. See Add a scheduled visit to a branch.
  7. Set the visit schedule and add cycling information for Branch B. See Define the visit schedule for a branch.
  8. Add the Follow Up branch to Branch A. This is done by adding a branch to the bottom of Branch A.
  9. Add the Follow Up branch to Branch B. This is done by adding a branch to the bottom of Branch B. Note that while this branch is the same as the one added to Branch A, it must be added separately to the bottom of each branch.
  10. Create a Study Completion Visit. See Create a visit or event.

Want to learn how to define visit branches for an oncology study? See your very own Tutorial for Creating and Managing Visit Branches in an Oncology Study.

A visual representation of visit branches defined for an oncology study

Figure 4-1 Visit branches in an oncology study

Visit branches are new visit schedules