How is data impacted when a site user undoes a subject's event?

Whenever a site user or any other user undoes a subject's withdrawal, screen failure, or study completion, your study's data is impacted in several places.

If a subject's withdrawal, screen failure, or study completion is associated with a visit with data already collected, that data can be impacted, depending on its nature. For example, certain custom JavaScript rules may need to be re-run, while signed or verified data may become unsigned or unverified. See the different use cases below.

General impact on the study's data for undone events

Consider the following notes:
  • Whether you're a user working on the sponsor team or you're part of the site staff, you should not attempt to enter additional data into the Screen Failure, Study Completion, or Withdrawal visit when the subject is not in the applicable state. This is because the data may not be retained in the system.
  • If you select Edit Screen Fail for a subject who was automatically screen failed, the reason for that subject's screen failure is read-only and you cannot update it on the Edit Screen Failure dialog.
  • The Undo Subject Screen Failure notification is only sent when a site user manually screen fails a subject. If you update data related to a validation that resulted in a subject being automatically screen failed, no notification is sent to you if the subject is then successfully re-screened.
  • To hide an associated Screen Failure, Study Completion, or Withdrawal visit, all data should be cleared from the visit. This includes the following:
    • All data, including hidden data;
    • All queries, whether automated or manual, should be closed;
    • All data flags should be cleared, not manually removed.

Impact on custom JavaScript rules

Here's what you need to know when it comes to how custom rules behave when a subject event is undone:
  • Whether it's specified or edited by a site user, or defaulted by the application, the date of a subject's withdrawal, completion, and screen failure (as well as the date of their undoing) is returned to the Subject Object attributes for the respective dates. The subject object used in custom rules throughout your study reflects the updated data.
  • If clearing a question triggers a calculation rule to populate a target field, in a visit that is being cleared, that visit should not be hidden until the calculation is cleared by the user. In a withdrawal, completion, or screen fail visit, when a site user clears data using the Clear option (and not by pressing the Backspace or Delete keys) and a subject's status doesn't match the status required to trigger the visit, the following may happen:
    • For example, if a subject's status is Completed and a site user attempts to clear data in a withdrawal visit, any rules that make use of questions in that visit will re-run.
    • After all rules run, the visit is evaluated for any data being present. This is to ensure that no calculation rules have populated values in the visit. If no data is present in the visit but there are open or answered queries, or open candidate queries the visit isn't hidden until the queries are closed, either manually by a sponsor user or automatically. Once all queries are closed, the visit is hidden, and a site user is redirected to the Subjects page.
    • If a subject's status is Withdrawn, their screen fail visit should not be hidden if the study setting to allow withdrawal after screen fail is selected, and a subject's status of Screen Failed has not been undone by a site user (through undoing the screen failure or rescreening the subject).

Impact on signed, verified, frozen, locked, or queried data

Here's how signed, verified, frozen, locked, or queried data may be impacted when a subject's visit is undone:
  • When a subject's Withdrawal, Screen Fail, or Study Completion event is undone, if the associated visit's data remains unverified, and is subsequently cleared, the subject's status is not marked as Unverified. This is due to unverified questions no longer being considered by the system. If not all data is cleared at once from a visit associated with an undone event, and the visit remains visible for sometime, any uncleared and unverified data is reflected in the subject's status.
  • When a subject is locked, while multiple visits associated with undone events are displayed, these visits become locked, as well. For a site user to clear their associated data, and hide them from the Subjects page, subject and their visits need to be unlocked by a sponsor user. Moreover, for a subject's whose status is Locked, the option to undo that subject's events is not displayed on the Manage Subjects drop-down.
  • If a subject's data is signed at the casebook level while a Withdrawal, Screen Failure, or Study Completion visit is visible, after clearing that visit's data, the visit is no longer included in the signature.
  • A site user may not have the permission to close all queries raised against a visit that's associated with an undone event. To get help with closing queries, they should reach out to their Clinical Research Associate (CRA).
  • Study Completion and Withdrawal visits should not be frozen until it is confirmed that the visits are required in a study. While it is possible to clear the visit's data and undo the subject's status, the visit remains visible in the User Interface (UI) due to the presence of the frozen question in the associated visit.

Impact on reports, data extracts, and archives

When a subject's visit is undone, data can be displayed differently in certain reports:
  • When a Withdrawal, Screen Failure, or Study Completion visit is undone and its data is cleared, data for that visit is no longer displayed in the Subject Data Extract. Any data associated with these visits that isn't cleared by a site or sponsor user, continues to be included in the Subject Data Extract.
  • The Subject Events Report, in the Visit/ Event Date column, displays the date of a subject's withdrawal, screen failure, or study completion event as entered by a site user. When a site user edits a subject's date for their withdrawal, screen failure, or study completion, the Event Type column displays this as a separate event (Completion Update, Withdrawal Update, or Screen Fail Update). The Visit/Event Date column also displays the new date for the event.

Impact on integrations

If your study has any EDC-related integrations, you can find more information in the Digital Gateway User Guide on how data on undone visits is sent to other applications:

Related Topics

Parent topic: Subject and data entry FAQs