Create a visit or event

Create one visit for each subject visit or event that occurs in the study. Since you have to create visits before you can design the visit schedule or configure any as dynamic, create the visits in the order that they will follow in the schedule.

Note:

  • 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 subjects will be added in the study after being screened outside Oracle Clinical One Platform, you don't need to create a Screening visit. This will allow site users to automatically enroll subjects from another system.
  • You may have multiple unscheduled visits in a study, but you can only have one Adverse Event and one form assigned to an Adverse Event.
  • If you want to insert a visit into the schedule of a study during study conduct period, see Set up an inserted visit into the schedule of a live study version.

Consider the following before creating a visit or an event in your study:

Want to see how to perform this task? Watch the video below.

  1. Access the Draft version of a study as described in Open a study's design.
  2. To create a scheduled visit:
    • If you haven't created any scheduled visits, on the Scheduled Visits sidebar, click Create Visit.
    • If you already created one or more visits, on the Scheduled Visits sidebar, click + to add more.
  3. To create an unscheduled visit or an event, in the Unscheduled Visit or Event sidebar, click the + button.
  4. Fill in the fields and click Save. To view tips for completing a field, click into the field or choose an option.
    Field Description
    Title

    Enter the name of the visit, such as Screening for a scheduled visit or Follow Up for an unscheduled event.

    ID

    Enter a short label for the visit, such as SCR for a screening visit. If your study's activities include running the Subject Data for CTMS report, make sure visit IDs are written using numbers and letters only.

    Type Select the type of visit.

    Note:

    For more details on what types of visits and events to create, see What types of visits can I create?
    Required

    This field appears only when Scheduled Visit is selected for Type.

    • Click Yes if all subjects must complete the visit.
    • Click No to make the visit optional.

    An optional visit appears for site users in the Next Visits column next to the subject's next required visit.

    Earliest Visit to Complete Study

    This field appears only when Study Completion Visit is selected for Type.

    Select the visit that subjects must finish to complete the study. If randomization occurs in the study, the study completion event must occur after the randomization visit. A study completion icon (Person with a check mark) appears on the visit you select.

    Only required visits that take place after the randomization (or baseline) visit can be selected as the earliest visit to complete a study. Optional and dynamic visits cannot be selected.

    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.
    Shown in Timeline

    Note:

    This field is displayed only when the visit is included in a draft version during the study conduct period.

    For this setting, you must select an option to determine how the visit will be displayed.
    • Future Only - All Scheduled Visit Types: choose this option if you want to add this visit only for subjects who did not progress past this date in the schedule. If this visit is part of a cycle then the visit is added only to future cycles.
    • Future & Past - All Scheduled Visit Types: choose this option if you want to add this visit for all existing subjects in the study, including subjects who did not progress past this date in the schedule. If this visit is part of a cycle then the visit is added to all cycles in a study.
The newly created scheduled visits appear on the Scheduled Visits sidebar. The newly created unscheduled visit or events appear on the Unscheduled Visit or Event sidebar.