Details for study designers

If you're familiar with creating scheduled visits and defining the dispensation scheduled for them, you can apply that knowledge to creating unscheduled visits. The workflow for designing unscheduled visits is very similar with just a couple of new steps.

New option for creating unscheduled visits

Create an unscheduled visit using the Create Visit or Event dialog. In the dialog box, you'll see a new option in the Type drop-down.

Note:

You can only create one unscheduled visit in a study.

Figure 20-16 Create an unscheduled visit

Unscheduled visits appear in the Visits & Events pane

Unscheduled visits now appear on the right after the scheduled visits, and before the study completion visit.

Figure 20-17 Unscheduled visit in the Visits and Events pane

You can assign forms to an unscheduled visit

A new option for unscheduled visits appears in the Assign Form to Visit dialog.

Figure 20-18 Assign forms to an unscheduled visit

New visit flyout for unscheduled visits

Clicking an unscheduled visit in the Visits & Events pane on the right opens a visit flyout where you can:

• Select a kit from the drop down for each treatment arm or all subjects. After a kit type is added, that kit is removed from the drop down for the treatment arm. Additionally, you can also drag and drop a kit on an unscheduled visit to define the dispensation for it.
• As with regular scheduled visits, you must add at least one form to an unscheduled visit.
• Change the visit type or visit ID.

Figure 20-19 Visit flyout for an unscheduled visit

Small changes in how you define the dispensation for unscheduled visits

• In the Add Kit to Visit Schedule dialog box you can now associate a kit type with an unscheduled visit, choose the treatment arm to associate with the kit type, and the options are the same as when you associate a kit type with a scheduled visit. That is, you can associate the kit type with one or more treatment arms, all treatment arms, or all subjects.
• You no longer see the Dispense Outside Window checkbox for unscheduled visits, because unscheduled visits don't have visit windows.
• Depending on how you defined the kits, the Calculated Dose column may or may not appear in this dialog box.

Figure 20-20 Changes for dispensing kits during an unscheduled visit

New options for dispensing kit type titrations during unscheduled visits

In the Create Kit Type Titration dialog box, you'll see a new column for unscheduled dose changes. The content of that column may change depending on the selection that you make for the Maximum Dose Changes option. For example:

• If you select Total, the Unscheduled Dose Changes column displays a drop down for the total number of dose changes that can occur during unscheduled visits.
• If you select Up and Down, the Unscheduled Dose Changes column displays two fields: one for the Up Titration Limit and one for the Down Titration Limit.

Additionally, you'll also see the Add Titration to Visit Schedule wizard where you can choose how to associate kit type titrations with treatment arms and subjects, and specify the DND (Days) value for each kit type titration that can be dispensed during an unscheduled visit.