Start with screening a candidate

Depending on your study's configuration, the initial step to add subjects in a study may be different. If subject numbers are assigned after screening forms are submitted, follow these steps.

To understand your study's workflow for assigning subject numbers, see An overview on subject number assignment.

When your study assigns subject numbers upon screening, consider the following:
  • You must answer all required questions to be able to screen a subject. If you skip a question that is marked as required, you can't screen the subject until that question is answered. Upon selecting Submit, any required questions that were left unanswered are flagged along the top of the page and highlighted in the screening forms.
  • The completion of hidden required questions is taken into account to determine a visit's status. If hidden required questions aren't answered, the visit is considered Incomplete. If all hidden and required questions are answered, the visit is considered Complete. If you have completed all required questions and still cannot complete your visit, contact your sponsor.
  • The Menu (Menu icon) is not visible for individual questions, hence you cannot apply data flags to screening questions.

    However, data flags are allowed after the subject number is assigned. For more information, see Apply a data flag to a question.

  • Until a subject number is assigned, you cannot link forms of that subject.
  • You cannot manually screen fail a subject until their Screening visit is complete.
  1. From the Home page, access your study in a specific mode. For more information, see Access study modes and pages.
  2. Along the top, make sure Subjects is selected.
  3. Filter your view based on data you need to see. For more information, see Filter subjects in a study.
  4. Select Screen Candidate. Upon selection, the following can happen:
    • If you're associated with multiple sites, the Select Site dialog appears. Select a site and you are redirected to the Screening visit forms.
    • If you're associated with a single site, you're taken directly to the Screening visit forms.
  5. If the form contains an editable Visit Date question, select today or an earlier date.
    Depending on how the study is set up, you might be allowed to edit the date after saving the form. The current day is always the latest date that you can select.
  6. Answer the questions on each form.

    Caution:

    Data in screening forms isn't automatically saved. During screening, if you leave the visit, select Return to All Subjects, or select Cancel, your data will be lost.
  7. Select Submit.
  8. If required, enter the subject's number on the Assign Subject Number dialog according to your study's guidelines, and select Submit.
Whether the subject is successfully screened or failed screening, a dialog displays the new subject number. Take note of that subject number to ensure that you record subject numbers outside of the system, too.
The screening outcome determines the next steps:
  • Successful screening: Select Next Visit to start the next scheduled visit, if one exists. You can begin creating form links.
  • Failed screening: If required, you may have to complete a visit related to the subject's screen failure.

Parent topic: Add a subject to a study