Create an unscheduled visit or event

Create one visit for each subject visit or event that occurs in the study. Create unscheduled visits or events to cover different subject events that can happen at any moment, irrespective of the visit schedule. For example: Adverse events, withdrawal, or study completion.

Note:

The Adverse Event visit is included in all studies by default. You can further define this visit and include as many forms as needed.

For more information about unscheduled visit types and events, see Understand visit types.

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. Expand the Unscheduled Visit or Event section on the sidebar and select +.
3. Fill in the fields and select Save or Save & Add Another:

   Field	Description
   Title	Enter the name of the visit.
   ID	Enter a short identifier for the visit. Caution: If your study's activities include running the Subject Data for CTMS report, make sure visit IDs are written using numbers and letters only, and follow expected naming conventions for the report.
   Type	Select one of the following: Adverse Event Screen Failure Visit Rescreening Visit Tip: You can select the Use Screening Visit as Template option when creating a Rescreening visit. This copies the screening visit 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. Study Completion Visit Withdrawal Visit Unscheduled Visit For more information see Understand visit types.
   Allow Next Visit Without Completion	Only available for Rescreening and Screen Failure visits. Enable this setting to allows site users to move on to the next visit and enter data if available. This is useful as sometimes data for the next visit becomes available prior completing the current visit; whether it is that the whole current visit data is not immediately available or may take significant time to enter into the system. The following criteria must be met for the next visit to display when this setting is enabled, even if the current visit is in progress or incomplete: At least one question for the visit is answered. It can be the visit date. All applicable Randomization and Trial Supply Management (RTSM) actions have occurred. Tip: To guarantee this, make sure you use this feature in combination with the toggles that define questions required for specific RTSM actions: Required for Screening Required for Randomization Required for Dispensation For more information see Specify RTSM actions that require complete answers. Any dynamic parent question for forms, visits or branches have been answered. There is a next visit to show, either a static visit or a triggered dynamic visit or branch.
   Earliest Visit to Complete Study	This field appears only for the Study Completion Visit. Select the visit that subjects must finish to complete the study. By default, subjects must complete or skip all required visits and start or skip all optional visits to be eligible for study completion. Select a visit in this field to allow a subject to complete the study without completing all required visits. This field is optional: If you select a visit, the option to Complete a subject will be available from the Manage drop-down for the subject as soon as the subject completes the given visit. If you do not select any value, all required visits need to be completed for the Complete option to be available in the Manage drop-down for the subject. Note: If randomization occurs in the study, the study completion event must occur after the randomization visit. If your study includes an enrollment visit, the earliest visit to complete must be after the enrollment visit. Optional, dynamic, and branch visits cannot be selected.
   Visit Date SDV	Specify whether the visit date is applicable for Source Data Verification (SDV). Select one of the following or leave both toggles set to Off: SDV For All Subjects: set this toggle On to make the visit date verification required for all subjects. Critical Variables (Targeted SDV): set this toggle On to make the visit date verification required only for the selected subjects as per the SDV strategy. For more information see Understand source data verification. Note: These toggles are Off by default. Only one toggle can be set On at a time.

The newly created unscheduled visit or events appear on the Unscheduled Visit or Event sidebar.

To add forms to your unscheduled visit or event, see Add a form to a visit.

You can create unscheduled dispensation visits but, you can only add kits for dispensation to unscheduled events of the type Unscheduled Visit. See Define the dispensation schedule