Siebel Clinical Trial Management System Guide > Administering Clinical Subjects and Clinical Visits >

Screening a Clinical Subject

The screening visits can be scheduled when the subject signs the informed consent form. The Subject Status MVG is automatically updated for the screening visit that was selected as the Status Tracking Visit in the subject visit template.

To screen a subject

1. Navigate to the Site Management screen, then the Protocol Site List view.
2. In the Sites list, drill down on the site for which you want to screen subjects.
3. Click the Subjects tab.
4. In the Subjects list, select the subject to be screened.
5. Enter the informed consent date:
   1. Click the Select button in the Informed Consent Dates field to open the Informed Consent dialog box.
   2. Click New.

      The versions of the subject visit template appear in the drop-down list of the Add Informed Consent dialog box. Make sure to select the version before entering the informed consent date.

   3. Click Add.
   4. In the Informed Consent Dates dialog box, enter an informed consent date for the subject and close the Informed Consent Dates dialog box.
6. Click the hyperlink in the Screening number (#) field of the subject.

   The Visits view of the Subjects screen appears.

7. (Optional) Edit subject visit dates or activities.

   For example, you might want to edit some subject visit dates so that visits are not scheduled on weekends.

   If the rescheduled date falls outside the range specified by the subject visit template, the application displays a warning message, but still reschedules the visit according to the new date.

8. Select the Completed option for the Screening visit in the Visits list.
9. Enter the completion date in the Completed Date field.

   If the subject clinical visit is a status tracking milestone visit, the Subject record automatically updates as follows:

   • A Screening Visit Type record is added to the Subject Status MVG.
   • The Status field is updated to Screened.
   • The Subject Status MVG Date field is populated with the date entered in the Visits list Completed Date field.