Not Answered flag for skipped visits

Details for data managers or other sponsor users

When it comes to your workflow, here's what's new for you when working with forms:

When you skip or leave a form empty, a Not Answered flag appears in the Visit History sidebar for that visit.
Certain visit types, such as Screening, Randomization, and Open Label transition visits, are excluded.
The Not Answered flag may take a short time to appear for all associated forms and items.
Visits that are already signed, verified, frozen, or locked are not updated with the Not Answered flag.
To remove the Skipped indicator and Not Answered flag, un-skip the visit and move it to In Progress.
When a new form is added to a skipped visit through Advanced Study Version (ASV), eligible items are included in reporting and downstream integrations.
If updates to a prior visit affect a dynamic form, the Not Answered flag may apply to all items within that form.

More information can be found in the Sponsor and CRO User Guide after the assessment environment upgrade completes.

Details for site users

When you skip or leave a form empty, the visit displays a Not Answered flag in the Answer History.
Forms within a skipped visit remain incomplete until updated.
You can skip and un-skip a visit as needed.
Restarting a skipped visit by entering a Visit Date clears previously incomplete fields so you ca enter new values.
Removing the Visit Date allows you to update fields with new values.
If a skipped visit was previously signed, verified, frozen, or locked, some incomplete fields may remain unchanged after the visit is un-skipped.
Existing skipped visits are updated to support the Not Answered flag where applicable.
If a skipped dynamic visit is no longer needed, it is hidden automatically.
If it becomes applicable again later, it reappears as a new visit.
When incomplete values are cleared, Answer History records both the original and cleared states.

More information can be found in the Site User Guide after the assessment environment upgrade completes.

Impact on reporting, archives and analytics

Form items from skipped-visit forms appear in Oracle Clinical One Analytics with a response state of Not Answered, reflecting that the visit was skipped and the form was cleared.

Depending on the amount of the data entered in the forms in a visit, the extract captures that data. If no date is entered, it is not reflected in the extract.

Reports Description of updates

Reports	Description of updates
Subject Forms dataset Subject Form Items dataset Subject dataset extract Subject Form SVFL dataset Subject Item SVFL dataset Subject Event SVFL dataset	Forms for unfilled or partially filled skipped visits are now included in the forms reporting datasets (only flat form types). These forms display the following existing fields as: `OPERATION_TYPE` field now displays CLEARED when a skipped visit is incomplete. `FORM_STATUS` field now displays DELETED status when a skipped visit is incomplete and in addition with the NOT ANSWERED flag when form items in a skipped visit is incomplete. `IS_CURRENT` field now displays N when a skipped visit is incomplete.

Subject Forms dataset
Subject Form Items dataset
Subject dataset extract
Subject Form SVFL dataset
Subject Item SVFL dataset
Subject Event SVFL dataset

Forms for unfilled or partially filled skipped visits are now included in the forms reporting datasets (only flat form types). These forms display the following existing fields as:

OPERATION_TYPE field now displays CLEARED when a skipped visit is incomplete.
FORM_STATUS field now displays DELETED status when a skipped visit is incomplete and in addition with the NOT ANSWERED flag when form items in a skipped visit is incomplete.
IS_CURRENT field now displays N when a skipped visit is incomplete.

More information can be found in the Analytics User Guide after the assessment environment upgrade completes.