Understand subject rescreening

In some cases, your study's protocol may call for allowing subjects to be rescreened. For example, a subject may not have met study protocol requirements at the time of their initial screening, but may meet the requirements at a later time.

Before you work with this feature

Prior to rescreening a subject, consider the following:
  • The Focused Rescreen view allows you to manage rescreening from within the rescreen visit for targeted data updates. This view is only available when Rescreen is selected from the Manage drop-down on the Subjects page.
  • Depending on how your study's settings are configured, all questions in the screening or rescreening visit are locked if the subject is automatically or manually screen-failed.

    For more information, reach out to your study manager.

User interface (UI) visibility

  • Be aware that the Rescreen option does not appear in the Manage drop-down for the following scenarios:
    • A rescreen visit has not been created for the study yet.
    • The subject has reached the maximum number of rescreen attempts.
    • A rescreen visit has not been created for the study yet.
    • The subject has reached the maximum number of rescreen attempts.
    • The subject is successfully screened, randomized, or enrolled.
    • The screen fail visit is started, or any data has been entered for the screen fail visit. The Rescreen option does not appear unless this data is cleared.
    • The subject has been withdrawn from the study.
    • There is no Screen Fail visit present and the study's settings are set to lock all screening/rescreening data for the previous visit.
    • Note:

      If all data is cleared during the screen fail event or an undo withdrawal is performed, if additional rescreen attempts remain, the Rescreen option becomes available again in the Manage drop-down.

      You are able to undo manual screen failures or update data that generated an auto-screen fail, as long as you have not moved on to another rescreen visit.

  • If a rescreen visit is triggered by a manual screen failure and the rescreen visit has been started but not completed, it is possible to undo the screen failure for the previous visit once the rescreen visit is cleared. This results in the rescreen visit being hidden.

    Note:

    If the subject is screen failed again, Rescreen must be chosen again in order to reuse the now hidden rescreen visit.
  • A Screen Fail or Rescreen visit is hidden in the UI if the subject has been successfully screened.
  • Once a Rescreen visit has been started, the Screen and Rescreen options are not available in the previous visit.

Subject data and status impacts

  • A subject's status remains as Screen Failed while they are rescreened. Once the subject has been successfully screened, their status updates to Screened.
  • If a visit has been started by entering any data, then cleared, the visit reverts to a status of Not Started and is hidden if the subject is successfully screened.
  • A record is added to the Subject History for each Rescreen visit. This record includes the following:
    • The result of the visit (Screen or Screen Failed).
    • The name of the visit as specified in the study's design.
    • The respective visit tile.
    • The reason (if applicable).
    • The system date of the event (Screen or Screen Failed).

Impact on reports

When applicable, rescreening data is available in the following reports:
  • Annotated Case Report Forms
  • Study Design report
  • Study Settings report (Study Settings tab)
  • Study Settings Report (Visit Settings tab)

For more information, see the Reporting Guide.

Notifications

For more information on notifications related to subject rescreening, see