Insert a visit into the visit schedule of a live study

You can now modify the visit schedule for a subject at any point in time during a live study version.

What are the benefits?

Previously, the visit schedule up to the current visit could not be modified once a subject had started a visit. Now, you are able to update the visit schedule for a subject at any time during a live study version, as required by study amendments to your protocol.

This feature offers multiple benefits and enhancements, such as:

• The ability to control the impact of the inserted visit, whether it should appear for all subjects or subjects enrolled in the future.
• The ability to include almost any type of visit in the visit schedule, along with assigned forms or kit types. The inserted visit can be an anchor visit.
• Allowing users to add forms to an existing visit.

Details for study designers

If you would like to insert a visit into the schedule of a live study version, there are multiple changes to your workflow:

• You can insert a visit both as a regularly scheduled visit or as a cycle visit, including as the last visit in a branch or cycle branch. You cannot insert a new screening or randomization visit.
• On the Add Visit dialog, the Shown in Timeline field determines how the visit will behave during the study. For example, when you select Future Only, the inserted visit will only show for subjects that have the visit scheduled in the future. This is the default selection for new and existing visits. But when you choose Future & Past, the inserted visit will always show even if a subject has completed the visit.
• In a subject's schedule, an inserted visit appears as a visit that has not been started yet.
• An inserted visit appears for completed and withdrawn subjects just the same as a visit that has not been started yet.
• The visit property that prevents displaying visits for subjects who have completed a visit follows the newly inserted visit.
• If you assign a new form to a newly inserted visit, then you must make sure that the questions in those forms are applied to the correct study version. For step-by-step instructions, see Add a new form to a live study version.
• Sites are required to be associated with the relevant study version in order for site users to see the visit.

Details for site users

Nothing has changed in your workflow. However, you must know that, depending on how an inserted visit is configured to impact a subject's schedule, this new visit may appear on the Next Visits column for you to complete.