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.

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

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

For a scheduled visit, you have to specify its schedule in your study, whether it is a screening visir or any other scheduled visit, such as a dispensation or baseline visit. An unscheduled visit doesn't require you to specify a scheduled 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. Withdrawal, screen failure, and study completion visits are also unscheduled.

Caution:

The completion of a hidden, required question is taken into account to determine a visit's status, but it won't be taken into account to determine a form's status. For example, if a hidden, required question isn't answered, the associated visit's status is considered Incomplete, while the form's status is displayed as Complete. If all hidden, required questions are answered, the visit is considered complete and so is the form.

While a visit’s status will match between Oracle Clinical One Platform and Oracle Clinical One Analytics, a form’s status is displayed as Incomplete in specific data sets, when the form contains a hidden and required question that’s unanswered. For more information, see the following topics in the Analytics User Guide:

Note:

Consider the following before creating a visit or an event in your study:
  • 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 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 Set up an inserted visit into the schedule of a live study version.
  1. Access the Draft version of a study as described in Open a study's design.
  2. To create a scheduled visit, follow these steps:
    1. Do one of the following:
      • If you haven't created any scheduled visits, on the Scheduled Visits sidebar, select Create Visit.
      • If you already created one or more visits, on the Scheduled Visits sidebar, select the + icon to add more.
    2. Fill in the fields and select Save or Save & Add Another. 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.
      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

      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.

      Select one of the following:
      • 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.
      • 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.
      Required
      This field appears only when you select Scheduled Visit for the Type field.
      • Select Yes if all subjects must complete the visit.
      • Select No to make the visit optional.

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

  3. To create an unscheduled visit or an event, follow these steps:
    1. On the Unscheduled Visit or Event sidebar, select the + icon.
      You will notice an Adverse Event is included by default.
    2. Fill in the fields and select Save or Save & Add Another:

      Note:

      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.
      Field Description
      Title

      Enter the name of the visit, such as 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 one of the following:
      • Study Completion Visit: Select to create the visit that appears when a site user completes a study for a subject.
      • Screen Failure Visit: Select to create the visit that can be used when a site user deems a subject as having failed screening.
      • Unscheduled Visit: Select to allow data collection, kit dispensation, or dose changes during an unscheduled visit. You can create multiple unscheduled visits in a study.
      • Withdrawal Visit: Select to create 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.
      • Adverse Event: Select to create an event 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.

        By default, every study contains an Adverse Event. 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.

        For site users, the adverse event appears on the first column right after the Subject ID.
      Earliest Visit to Complete Study

      This field appears only when you select Study Completion Visit for the Type field.

      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 (Study completion) 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.
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.

Related Topics

Parent topic: Visits and schedules