Specify visits settings

Specify visit settings to control visit dates, notifications, and other visit-related parameters.

  1. Navigate to the Study Settings tab and determine in which mode you want to work. See Specify study, enrollment, and visits settings.
  2. Under Visit Settings, configure the following settings for each visit type:

    Note:

    Not every setting is available for every visit type. The available visit types to configure are:
    • Screening
    • Rescreening
    • Enrollment
    • Randomization
    • Dispensation
    • Non-Dispensation
    • Optional
    • Unscheduled
    Setting Description Can be changed anytime during the study conduct period
    Site Enters Visit Dates
    Select if site users can enter the visit date. This must be either the current date or an earlier date.
    • If this setting is checked for a visit, the system does not automatically update the visit date to the current date upon form data entry.
    • If this setting is not checked, a site user cannot enter a visit date and, upon form data entry, the system automatically updates the visit date to the current date.
    Yes
    Site Edits Visit Date
    Select if site users can edit the visit start date after the form has been saved.
    • If the previous setting (Site Enters Visit Dates) is checked, this setting is also enabled by default and cannot be unchecked.
    • Only if he previous setting (Site Enters Visit Dates) is unchecked, you may update this field.

    Tip: The visit schedule is based upon the visit date, and if site users enter data prior to the visit date, the visit schedule might not be calculated as expected. If you expect that site users will enter data for a visit prior to the visit date, consider allowing them to edit the visit date. Otherwise, the visit start date that is recorded might not be accurate.

    Yes.
    Visit Date Must Be On or After Randomization

    Only for the Randomization visit.

    Select if the visit date for the randomization visit must be on or after the date when the subject was randomized, which is when site user clicked the Randomize button for the subject.

    No
    Allow Randomization Replacement

    Only for the Randomization visit.

    Select if you would like to allow for randomized subjects to be replaced if they are withdrawn early from the study. When this happens, a new subject that gets randomized for the same treatment arm takes its place and gets a randomization replacement number, conformed by the replacement starting prefix and the original randomization number.

    When you enable this setting, you're prompted with additional selections:

    • Replacement Starting Prefix: Add a prefix for the randomization replacement. The prefix increases by an integer of 1 for each replacement.

      A maximum number of 9 digits for the prefix is allowed. When editing the prefix, you cannot enter an integer lower than the previously entered prefix.

    • Set Max Replacements per Randomization Number: Enable this setting if you want to specify how many times a randomization number can be replaced. I enabled, you are then required to add a quantity in the Max Replacements field.
    Yes
    Visit Date Must Be On or After Dispensation

    Only for the Dispensation visit.

    Select if the visit date must be on or after kits are dispensed, which is when the site user clicked the Dispense button for the subject.

    No
    Visit Can Be Skipped

    Select to allow site users to mark a visit as skipped when a subject doesn't come in for a scheduled visit.

    Optional visits can always be skipped and, on the other hand, screening, enrollment and randomization visits cannot be skipped. For this reason, this setting is only available for scheduled visits of the following visit types:
    • Non-Dispensation
    • Dispensation

      Warning: If site users skip a dispensation visit, they won't be able to dispense for the visit unless they undo the skip and complete the required fields on the forms in the visit.

    Yes
    Send Visit Notification
    Select to allow study team members and site users to receive notifications for subjects completing each type of visit.
    • Select Success and Failure to make sure they receive both types of notifications.
    • Select Failure Only to be notified only when the visit presents errors.
    Yes
  3. Select Save Changes and choose between saving to current mode or to all modes.