Enroll a subject

Enroll a subject that has been successfully screened as is ready to be an active participant in the study. The moment and workflow to enroll a subject depends on the study design and protocol.

Note:

Enrollment is only available for studies without randomization.

• In rollover studies, where subjects are screened in an external system, subjects are automatically enrolled when added. See Enroll a subject in a rollover study.
• If the visit schedule does not include an Enrollment type visit, a subject is automatically moved from a status of Screened to Enrolled when they complete the visit following the Screening type visit.
• If the visit schedule includes an Enrollment type visit, enrollment occurs only after completing the enrollment visit. This occurs upon selecting the Enroll button in an Enrollment type visit.

  To complete an enrollment visit, follow the steps described in this document.

For more information on visit types, see Understand visit types.

1. From the Home page, access your study in a given mode. See Access study modes and pages.
2. Along the top, make sure Subjects is selected.
3. On the subjects list, locate the subject you want to enroll, and select the enrollment visit in the Next Visits column.

   Tip:

   You can filter your list of subjects, see Filter subjects in a study.
4. For the Visit Start Date field, select today or an earlier date. Depending on how the study is set up, you might be allowed to edit the date after saving the form.
5. Answer questions on each form.
   Make sure you answer at least all the required questions.
6. Select Save and complete the visit:
   • To complete an enrollment visit, select Enroll. This button triggers a Subject Enrollment confirmation dialog.

     Note:

     • If the subject or the enrollment visit is locked, the enrollment button does not display.
     • If design validations are failed on a required field, the enrollment button gets disabled until the validations are corrected.
   • If you want to save your changes and enroll subject or dispense kits later, select Save & Close.
7. Review the information in the confirmation dialog and select Enroll.
   1. Verify the date of enrollment and update if necessary.
   2. Select Yes, I want to enroll this subject to confirm the action.
      The Enroll button triggers the enrollment event and makes the subject acquire a state of Enrolled.

For enrollment visits with dispensation, you must Enroll the subject first, then the Dispense button appears. In these cases, visit is considered complete only after dispensation happens. For more information on how to complete a visit with dispensation, see Complete a randomization or dispensation visit.

The enrollment event can be undone, which makes the enrollment visit incomplete. For a subject to be enrolled again, the enrollment visit must be completed again.