What types of visits can I create?

There are three different types of visits that you can create in a study: scheduled visits, unscheduled visits, and events. These distinct types of visits and events appear on two different sidebars and some of them have their own particular options.

Visit type Description
Scheduled visits are created and displayed separately on the Scheduled Visits sidebar.
These are visits that you can specifically schedule in your study, whether they're screening visits or other scheduled visits, such as dispensation or baseline visits.
  • Screening Visit: Choose this option if the visit is for screening. Typically, you should have one Screening visit in a study. A rollover or integrated study does not require a screening visit.

    Note:

    If you make a screening visit optional, a subject's status may advance differently than expected.

    This can occur if a user completes an optional screening visit after completing future visits. The recommended practice is to notify the study users when the screening visit is optional to avoid confusion.

  • Scheduled Visit: Choose this option to include a scheduled visit that can be used for regular data collection, randomization or dispensation purposes, or as an optional visit.
The system displays unscheduled visits separately on the Unscheduled Visits & Events sidebar.
An unscheduled visit doesn't require you to specify a schedule for it. This visit can be included in a study so a site user can start an unscheduled visit whenever they might need to perform data collection or dispensation outside of the normal schedule. Wthdrawal and study completion visits are also unscheduled.
  • Study Completion Visit: Choose for the visit that appears when a site user completes a study for a subject.

    Note:

    You can only create a Study Completion visit once you have a scheduled and required visit included after the Screening visit. Make sure that this required visit is not included in a visit branch.
  • Screen Failure Visit: Choose for the visit in which a subject is screened, but I actually ineligible to for the study.
  • Unscheduled Visit: Choose if you want to allow data collection, kit dispensation or dose changes during an unscheduled visit. You can create multiple unscheduled visits in a study.
  • Withdrawal Visit: Choose for the visit that appears after a subject is withdrawn. Only one visit can be the withdrawal visit, and it can't be the first visit.
The system displays events separately on the Unscheduled Visits & Events sidebar, together with other types of unscheduled visits.
An event is considered a different type of an unscheduled visit in the application. Typically, you create an event (specifically, an Adverse Event) for site users to collect data on adverse events, safety checks, hospital visits, and more.
  • Adverse Event: Choose if the event is only for collecting multiple instances of data on adverse events, concomitant medications, concomitant procedures, hospitalizations, adverse events of significant interest, or serious adverse events outside of the visit schedule. You can assign any type of form to an Adverse Event to collect multiple instances of data from the same subject, when needed. You can only have one Adverse Event in a study and you can edit or delete that event. However, you can't assign kits, devices, or randomizations to the adverse event visit.

    For site users, the adverse event appears on the first column right after the Subject ID.

  • Event: Choose if the event is only for collecting multiple instances of data from a subject, multiple times throughout the study.