Understand visit types

You can create two types of visits in a study. The scheduled visits are those that are part of the subject schedule, while unscheduled visits can happen at any moment. Both scheduled and unscheduled visits can be of different sub-types depending on the subject events they are intended to cover.

You create visits as either scheduled or unscheduled, and upon creation you must select the specific type.

Note:

You can change the visit type for an existing visit at any time. However, it is recommended to avoid converting a visit to any other visit type if the study version is already Approved. To ensure smoother updates to the visit schedule and the study design, it is recommended that you create a new visit instead.

Some restrictions apply to change an existing visit's type. For more information, review the description for each visit type listed on this page.

Scheduled visits

For a scheduled visit, you have to specify its schedule in your study. Upon creating a scheduled visit, you must select its type. Overall, there are three different types of scheduled visits:

Visit type	Description
Screening Visit	This is a specific type of scheduled visit that triggers the screening subject event upon completion. A screening visit allows you to collect data for subjects that need to be screened before they are enrolled in a study. Whether your study requires a screening visit or not, depends on your study protocol. For example, there are rollover or enrollment (registration) studies where subjects are screened in an external system and don't require you to create a screening visit in Clinical One Cloud Service at all, unless those subjects need to be re-screened. See Understand the requirements for a screening visit.
Enrollment Visit	This is a specific type of scheduled visit that triggers the enrollment subject event upon completion. An enrollment visit is used to extend the screening period and avoid auto enrollment after screening. It allows flexibility for site users to manually screen fail a subject if needed before enrollment, and for enrollment to actually happen only after passing the screening period and completing the enrollment visit. If your study requires an enrollment visit, consider the following: Only one enrollment visit is allowed in a subject's visit schedule and it must always come after the screening visit. The enrollment visit must be required (cannot be made optional) and cannot be skipped. The enrollment visit cannot be the earliest visit to complete the study and cannot occur after the earliest visit to complete the study. Studies with randomization cannot have an enrollment visit and enrollment visits cannot have randomization. Note: For studies with randomization, after the screening visit when randomization occurs, subjects go to Active state instead of Enrolled. Enrollment visits cannot be dynamic. For studies with branches, the enrollment visit must occur before branching (cannot be part of a branch). The enrollment visit cannot be converted to any other type of scheduled visit, nor can any other visit type be converted to an enrollment visit. You can add dispensation to an enrollment visit. All kit types are supported, including titration, devices and advanced dispensation.
Scheduled Visit	Create this type of visits to allow data collection, randomization, or kit dispensation as part of the subject's schedule. You can create multiple scheduled visits in a study.

For step-by-step instructions to create a scheduled visit, see Create a scheduled visit.

• If you want to create a visit that must be dynamically scheduled, make sure you review all details and restrictions listed in Set up a dynamic visit.
• If you want to insert a visit into the schedule of a study during study conduct period, see Update the visit schedule during a live study.

Unscheduled visits

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. Different types of unscheduled visits exist to cover different subject events that are typically unscheduled:

Visit type	Description
Adverse Event	This type of unscheduled visit, serves to collect multiple instances of data on adverse events that are not linked to a specific visit, such as concomitant medications, concomitant procedures, hospitalizations, adverse events of significant interest, or serious adverse events outside of the visit schedule. An Adverse Event can collect multiple instances of any form during the study, and this can occur at any time and more than once. The adverse event visit is included in all studies by default. You can further define this visit and include any type of form to collect multiple instances of data from the same subject, when needed. However, you can't assign kits, devices, or randomization to the adverse event. For site users, the adverse event appears on a dedicated column right after Subject ID, so that it is available to collect data at any time.
Screen Failure Visit	This visit is used when a site user deems a subject as having failed screening. During the study conduct period, this visit appears when a subject is either auto-screen failed, based on a validation rule, or if a site user selects Screen Fail from the Manage drop-down for the subject.
Rescreening Visit	This type of visit allows the subject to be rescreened after being screen failed, either manually or automatically (driven by defined validation rules). The option to create a rescreening visit is only available once your study has a screening visit. However, the option to create a rescreening visit is not available if randomization is included in the screening visit. Tip: You can select the Use Screening Visit as Template option when creating a Rescreening visit, so that the screening visit is copied, including all forms and their sequence, and any kits assigned for dispensation. Any kits and forms copied from the screening visit can be later modified within this rescreening visit and it does not impact the screening visit. Similarly, updating the screening visit does not impact the rescreening visit once it has been created. If your study allows the reescrening event, consider the following: More than one rescreening instance can occur during the study conduct period, but this is limited by the maximum number of attempts defined in your study's settings. You cannot branch from a rescreening visit. You can add kits for dispensation, but you cannot add titrations. The rescreening visit cannot be converted to any other type of unscheduled event, nor can any other event type be converted to a rescreening visit. Rescreening visits cannot be dynamic, however, they support dynamic forms and dynamic unscheduled visit triggers. If the screening visit is used as the Scheduled From visit (when defining the schedule for a next visit), the rescreen visit date (if successfully) is used to calculate the visit window instead of the screening visit date .
Withdrawal Visit	This visit displays after a subject is withdrawn. Only one visit can be of this type, and it can't be the first visit for a subject. During the study conduct period, this visit appears when a site user selects Withdraw from the Manage drop-down for a subject.
Study Completion Visit	This visit appears when a site user completes a study for a subject. This happens when a site users selects Complete from the Manage drop-down for the subject, during the study conduct period. You can only create a Study Completion visit once you have two required visits in your study. Make sure that these required visits are not included in a visit branch.
Unscheduled Visit	Create this type of visits to allow data collection, kit dispensation, or dose changes out of schedule. You can create multiple unscheduled visits in a study. These visits can be triggered dynamically by using the Show Visit rule, or by selecting the visit from the Manage drop-down for the subject.

For step-by-step instructions to create an unscheduled visit, see Create an unscheduled visit or event.