Screen fail a subject

If a subject has already been screened but is actually ineligible for the study, or becomes ineligible for the study prior to randomization, you can manually mark the subject as screen failed.

Want to see how to perform this task? Watch the video below.

  1. On the Home page, determine where to work. For more information, see Access study modes and pages.
  2. Along the top, make sure Subjects is selected.
  3. Filter your view based on the required criteria. For more information, see Filter subjects in a study.
  4. In the table, locate the subject you want to screen fail.

    Tip:

    If the subject has been randomized with a status of Active, you can't screen fail the subject, but you can withdraw the subject. See Withdraw a subject.

    Subjects who can be screen failed typically have a status of New, Enrolled, or Screened.

  5. Select the checkbox to the left of the subject.
  6. From the Manage Subjects drop-down, select Screen Fail.
  7. On the Screen Fail dialog, from the Reason for Screen Fail drop-down, select a reason for manually screen failing this subject.
  8. Verify or update the date specified in the Date of Screen Fail field.
  9. Select the required checkbox to confirm that you want to screen fail this subject.
  10. Select Screen Fail.
    If the study contains a Screen Failure visit, the visit is opened. The Screen Failure Visit is also displayed on the Next Visits column.
A subject who is screen failed appears with a Screen Failed icon on the Subjects page (Screen Failed).