Specify visits settings
Specify visit settings to control visit dates, notifications, and other visit-related parameters.
- Navigate to the Study Settings tab and determine in which mode you want to work. For step-y-step guidelines, see Specify study, enrollment, and visits settings.
- Under Visit Settings, configure your settings appropriately and select Apply Changes:
- Apply to Production to use the study settings only for your approved study.
- Apply to All Modes to use the study settings in all three modes: Testing, Training and Production.
Setting Can be changed anytime during the study conduct period Description Site Enters Visit Dates Yes Select the types of visits for which site users can select either the current date or an earlier date as the visit start date.- If this setting is checked for a visit, a site user can enter a visit date prior to entering visit data in the form. When data is entered (outside of the Visit Start Date field), the system does not automatically update the visit date to the current date.
- If this setting is not checked, a site user cannot enter a visit date prior to entering visit data in the form. When data is entered, the system automatically updates the visit date to the current date.
Site Edits Visit Date Yes. You turn off the setting when Site Enters Visit Dates is deselected. Enable it only when Site Enters Visit Dates is on Select the visits for which site users can edit the visit start date after the form has been saved.
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.
Tip:- For screening visits, this setting is useful when sites enter data for the screening visit on a later day than when the site user clicked Screen for the subject.
- For dispensation visits, this setting is useful when a site must click Dispense prior to the subject coming in for a visit, such as if a pharmacist must prepare the product in advance for the subject.
Visit Date Must Be On or After Randomization No Select if the visit date for the randomization visit must be on or after the date when the site user clicked the Randomize button for the subject.
Tip:- This setting is useful for when a site starts the randomization visit before the visit date. For instance, if a site user starts entering data for a form on Monday, the visit date is set to Monday. However, if the subject doesn't come in until Wednesday, and the site user doesn't click Randomize for the subject until Wednesday, Oracle Clinical One Platform requires the site user to update the Visit Start Date to Wednesday.
- This setting is also useful if a site has to complete a randomization visit prior to the subject arriving for a visit, such as for when a compound must be prepared for the subject.
Allow Randomization Replacement Yes 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: This option requires you to add a prefix for the randomization replacement. The prefix increases by an integer of 1 for each replacement.
Note: 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: This option allows you to specify how many times a randomization number can be replaced. You are then required to add a quantity in the Max Replacements field.
Visit Date Must Be On or After Dispensation No Select if the visit date for the type of visit must be on or after the date when the site user clicked the Dispense button for the subject.
Tip:- This setting is useful for when a site starts the dispensation visit before the visit date. For instance, if a site user starts entering data for a form on Monday, the visit date is set to Monday. However, if the subject doesn't come in until Wednesday, and the site user doesn't click Dispense for the subject until Wednesday, Oracle Clinical One Platform requires the site user to update the Visit Start Date to Wednesday.
- This setting is also useful if a site has to complete a dispensation visit prior to the subject arriving for a visit, such as for when a compound must be prepared for the subject.
Visit Can Be Skipped Yes Select to allow site users to mark a visit as skipped when a subject doesn't come in for a scheduled visit.
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. Site users can always skip optional visits and can never skip the following visits:- Screening and randomization.
- A required visit that occurs before the screening visit.
- Any visit for which data has been entered.
Send Visit Notification Yes Select to allow study team members and site users to receive notifications for subjects completing their screening, non-dispensation, optional, and unscheduled visits.- 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.
Tip: This setting is useful for all study team members who should know if subjects have successfully completed their visits, if they couldn't be screened, or if they couldn't successfully go through their visit.