New enrollment visit type

For studies that require additional visits after screening, before the subject is officially enrolled in the study, study designers can now add a scheduled visit of the new Enrollment type.

The enrollment visit eliminates the need for the system to enroll the subject immediately after screening. By introducing an enrollment visit, subjects stay in a screened state for a longer period, between the screening visit and the enrollment visit, which is closer to the reality of some clinical trials. This 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.

Details for study designers and sponsor users

Study designers can add an enrollment visit in the same way they add any other scheduled visits. No new permission is associated with this feature. However, you must consider the following if an enrollment visit is added to the study:

• Only one enrollment visit is allowed in a study's visit schedule.
• The enrollment visit must be required (cannot be made optional) and cannot be skipped.
• The study must have a screening visit, and the screening visit must happen before the enrollment visit.
• The enrollment visit cannot be the earliest visit to complete the study and cannot occur after the earliest visit to complete the study.
• Auto-enrollment will not happen for a visit schedule that includes an enrollment visit.
• 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).
• You can add dispensation to an enrollment visit. All kit types are supported, including titration, devices and advanced dispensation.
• Sponsor users must configure the following visit settings, for the Enrollment visit type, in the Study Settings tab:
  • Site Enters Visit Dates
  • Site Edits Visit Dates
  • Send Visit Notification
• Rules and existing scheduled visit behaviors can be configured for this new visit type.
• The new Subject Enrollment notification is sent upon subject successful enrollment to all users assigned with the new Receive the Subject Enrollment Notification permission.

  Additionally, the existing Subject Visit notification is sent for the enrollment visit when completed, either successfully or with failures.

You can find additional information in the Sponsor and CRO User Guide, Study Designer User Guide, and the Notifications and Permissions Guide after the assessment environment upgrade.

Details for site users

If your study uses the new enrollment visit type, you must consider the following:

• To complete an enrollment visit, site users must select Enroll. This button triggers the enrollment event and makes the subject acquire a state of Enrolled.
• For enrollment visits with dispensation, site users click Enroll first, then the Dispense button appears. In these cases, visit is considered complete only after dispensation happens.

  Note:

  If dispensation rollback occurs, the enrollment visit becomes Incomplete and the Dispense button displays again. Dispensation needs to be completed again for the enrollment visit to become Complete.

  For more information on this new rollback dispensation feature, see Define dispensation rollback.

• The enrollment event can be undone, which makes the enrollment visit incomplete. For a subject to be enrolled again, the enrollment visit must also be completed again.
• The option to screen fail a subject is not available after the subject completes the enrollment visit. However, upon undo enrollment, the enrollment visit becomes incomplete and the option to screen fail becomes available again.
• If the subject or the enrollment visit is locked, the enrollment button does not display. Conversely, freezing does not impact the enrollment action availability. However, undo enroll is not available in either state (locked of frozen).
• If design validations are failed on a required field, the enrollment button gets disabled until the validations are corrected.

You can find additional information in the Site User Guide after the assessment environment upgrade.

Impact on reports

The following table describes this feature's impact to reports:

Report	Description
Annotated Case Report Forms Study Design report Study Settings report Subject Events report Subject Visits report Subject Queries report Subject Data report Subject Data Extract	Existing reports that include visits details now support and include information on the new Enrollment type of visit. Note: In the Subject Events report, if the an enrollment visit is added to a study, details of the first enrollment of a subject display for a subject that is already enrolled. This is disregarding the enrollment event triggered after the newly added enrollment visit.
ODM-XML extracts	The ODM metadata extract is updated to support the new visit type.

You can find additional information about reports in the Reporting Guide after the assessment environment upgrade.

For more information about the impact on Oracle Clinical One Analytics, ODM Extracts, and other applications, see Release impact on downstream applications.

Already working in a live study?

To introduce the enrollment visit in a study is completely optional, and mainly depends on the study protocol and the decisions made by the study team. If you need to add an enrollment visit in an existing study, you can do so by configuring the visit in a new study version. This means the changes in the schedule will only impact subjects in the sites that use that new study version. For subjects in the following states and status, the enrollment visit will not show up as a future (not yet started) visit, unless data was entered for it:

• Locked
• Screen Failed
• Withdrawn
• Completed

No changes are applied in new or existing studies that do not include an enrollment type visit.