Enhanced analytics visibility of missing data across visit types

To ensure that reports, dashboards, and downstream integrations accurately reflect the current status of a study, Oracle Clinical One Analytics now persists all scheduled and expected visits and forms, including dynamically triggered visits, visit branches, cyclic visits, and associated forms. In addition, the logic of forms and visits that are considered missing has been updated to consider static and dynamic forms, as well as visit schedules that include dynamic visits, cycles, and branching.

Details for sponsor users

As a data manager, you can now leverage the following changes to Oracle Clinical One Analytics to perform data review and issue resolution at the appropriate time:
  • The system now persists records for upcoming, scheduled, and dynamically triggered visits, including visit branches, cyclic visits, and their associated forms. These records are associated with the subject.
  • • Dynamic visits, visit branches, cyclic visits, and their associated forms are now included in missing data evaluation.
  • A form or a visit is referred to as missing whenever it should have been completed, but is not yet started.

Details about changes to visits, forms, and questions

As a data manager, you should be aware that the system now creates and stores records of upcoming or scheduled visits. Such records are associated with the subject those visits pertain to.

You should also be aware of the following changes to the way visit statuses are determined:
  • Future visits now keep the status of SCHEDULED until they are started. Once a visit is started, the status changes to IN_PROGRESS.
  • Visits inserted in the study design as part of Advanced Study Versioning (ASV) are now considered missing (IS_MISSING=Y) and have a status of NEW.
The behavior of forms has also been adjusted as follows:
  • Forms associated with visits with a status of SCHEDULED also have a status of SCHEDULED.
  • When a visit transitions to IN_PROGRESS, its forms transition to NEW or OPTIONAL, as applicable.
  • Once a form is started, it receives a status of IN PROGRESS.
  • If a form is triggered, but the condition that led to its triggering changes, it receives a status of DELETED.
  • Forms associated with a visit that is identified as missing are also considered missing.

Impact on reports, extracts, archives, or datasets

Oracle Clinical One Analytics users can now generate reports and dashboards that include the following new elements:
Dataset Type of change Description
Blinded Subject Events dataset Changes to existing data elements
  • The IS_MISSING_VISIT element now receives a value of Y only when the visit includes:
    • the status of either SCHEDULED or NEW.
    • an associated PROJECTED_VISIT_END_DATE element, containing a value older than that of SYSTEM_DATE.
    • not skipped.
    • the IS_CURRENT element with a value of Y.
  • The VISIT_STATUS element can now also receive a value of NEW whenever the visit was either dynamically triggered or added as part of ASV.
Unblinded Subject Events dataset Changes to existing data elements
  • The IS_MISSING_VISIT element now receives a value of Y only when the visit includes:
    • the status of either SCHEDULED or NEW.
    • an associated PROJECTED_VISIT_END_DATE element, containing a value older than that of SYSTEM_DATE.
    • not skipped.
    • the IS_CURRENT element with a value of Y.
  • The VISIT_STATUS element can now also receive a value of NEW whenever the visit was either dynamically triggered or added as part of ASV.
Subject Forms dataset Changes to existing data elements
  • The IS_MISSING_FORM element now receives a value of Y only when the following conditions are met:
    • the form has a status of either SCHEDULED or NEW.
    • the value contained in the parent visit's PROJECTED_VISIT_END_DATE must be older than that of SYSTEM_DATE.
    • the form has not been skipped.
    • the form's associated IS_CURRENT element has a value of Y.
  • The FORM_STATUS element can now also receive the following values:
    • OPTIONAL: the form does not have any required or completed items
    • NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of ASV.

You can find additional information regarding these changes in the Analytics User Guide after the assessment environment upgrade.

Parent topic: Data Collection