Manage screen failure subjects

Sponsor users can now set configurations that allow subjects who have failed screening to complete or withdraw from the study.

Details for sponsor users

Under the Study Settings tab, the new Screen Failed Subjects configuration provides you with multiple options to enhance your screen failed subject management:

• By selecting Allow Screen Fail before Screening, subjects can be manually screen failed if they have not yet been screened.
• By selecting Allow Withdrawal, on the Subjects page, the Withdraw option becomes available for screen failed subjects.
• By selecting Allow Completion, on the Subjects page, the Complete option becomes available for subjects who have failed screening.

  Note:

  The Allow Withdrawal and Allow Completion settings are deselected by default for existing studies.
• By selecting Yes for the Allow Withdrawal for Subjects before Enrollment configuration, the ability to withdraw subjects before they've been enrolled in a study becomes available.
• Screen failed visits can now be included in a subject's visit schedule.

More details on configuring these settings can be found in Specify study enrollment and visit settings after the Release Assessment Environment upgrade.

Details for site users

When it comes to your workflow, here is what's new for you:

• If your study's settings have been configured to allow for screen failed subjects to withdraw from the study, the Withdraw option is enabled in the Manage Subjects drop-down, and withdrawal event forms become available to record additional data.
• If your study's settings have been configured to allow for subjects who have failed screening to complete the study, the Complete option is enabled in the Manage Subjects drop-down, and completion even form become available to record additional data.
• Withdraw and or Complete are not available in the Manage Subjects drop-down if they are not selected in the study settings.

Step-by-step instructions on managing screen failed subjects can be found in the Site User Guide after the Release Assessment Environment upgrade.

Impacts on reports

The Study Design report and Subject Events report have been enhanced to include details on screen failed subjects.