How do visits display in subject listings view, when integrations populate a future visit?

When data is populated in a visit by an integration, specifically Data Intake integrations, visits in the subject listings view display differently compared to standard data entry. This occurs, if the Data Intake integration populates data, in an order other than what is defined in the visit schedule.

For more information on visit status icons, see Visit statuses and icons

How are visits displayed after a Data Intake integration loads data into Oracle Clinical One Platform?

• If data is populated in a future visit by an integration, specifically a Data Intake integration, prior to preceding visits being started manually, the user interface displays any preceding, not-yet-started visits defined by the visit schedule, making them available for data entry. The Data Intake visit will appear in the Next Visit column.

  Note:

  If all preceding visits were started prior to a Data Intake integration loading data, the Data Intake visit also displays in the Next Visit column.
• The preceding visits, displayed on the subject listing and visit details pages are identified by a dotted border, and the label, (Not Started).

How are the Next and Previous Visit columns affected by a Data Intake integration?

• If the visit populated by a Data Intake integration is in progress the visit appears in the Next Visit column.
• If the visit populated by a Data Intake integration is complete the visit appears in the Previous Visits column.
• Screening, pre-screening, and any first visits defined in the visit schedule display in the previous visit column with all other (Not Started) visits in the order defined by the visit schedule. If the Screening visit is incomplete it will be moved to the Previous Visit column should a Data Intake integration populate a future visit.
• In the event of sequential Data Intake integrations, the last integrated data intake visit appears in the Next Visit column if the visit is in progress, and if complete it appears under Previous Visits.

What happens if a visit is added to the schedule with a site study version change?

• If the sponsor chose to apply new visits as future and past during design, the new visits display for all subjects in the correct location in the visit train, even if a subject has already passed the visit in their visit schedule. This is true, even if the visit is added between not started visits.
• If the sponsor chose to apply new visits as future only during design, the new visits display only for those subjects who have not yet progressed past that point in the visit schedule.

Are subjects in different status affected differently?

• Subjects with a Screen Fail or Withdrawn status:
  • Data can be entered for existing Not Started visits through the user interface or a Data Intake integration after a subject status changes to Screen Fail or Withdrawn, however, future visits cannot be added.
• Subjects with a Complete Status:
  • If an earliest visit completion requirement was defined for a study, the visits up to the completion visit need to be completed before the subject can be marked complete. This includes any (Not Started) visits.
  • If an earliest visit completion requirement was not defined for a study, the subject can be marked complete even when (Not Started) visits are present. Data entry is allowed for Not Started visits even after the subject is marked complete.

How does this impact subjects at a retired site?

• Users are prevented from clicking into (Not Started) visits for any subject at a retired site, but a Data Intake integration can still populate data for a subject at a retired site.

Is there an impact to reporting?

Yes, to the Subject Visits report (both blinded and unblinded).

• Report output displays what is visible in the user interface.
• Not Started visits appear at the end of the report with visitdate and projectedvisitdate showing as N/A.
• If data is integrated after the screening visit, or the first visit in the visit schedule, where no data has been entered, including visit date, the screening visit does not include a date value for visitdate and projectedvisitdate’