Add and screen a subject

Ready to screen a new subject? Here's where you start. Remember that this procedure doesn't apply to rollover studies. Subjects enrolled in a rollover study have already been screened in the original study, and don't need to be screened again in the rollover study.

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

Note:

• The completion of hidden questions is taken into account to determine a visit's status. For example, if hidden questions aren't answered, the visit is considered Incomplete. If all hidden questions are answered, the visit is considered Complete.

• You must add all subjects directly into Oracle Clinical One Platform, not from an external system. Subjects that are added after being screened and randomized outside Oracle Clinical One Platform are automatically enrolled in the study and you don't need to screen them again. However, if the study design includes a screening visit you might need to screen the subject. A subject that is added from another system receives a status of Enrolled.

• If you enter data that doesn't meet the requirements specified by the sponsor in the form fields, a message explains why the answer does not meet the required criteria. If the question is marked as required, you can't randomize or dispense until it is answered. If the question isn't marked as required, you can randomize or dispense without answering.
• When the visit contains a two-section form, if you completed all of the required questions in the first section of the form and there are no table rows added to the second section of the form, then the two-section form is considered complete. If you completed all of the required questions in the first section of the form, but there are any incomplete rows in the table section of the form, then the two-section form is considered incomplete.

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 country and sites. For more information, see Filter subjects in a study.
4. Click Add Subject.
5. If entering subject numbers is allowed at your site, in the Add Subjects dialog, enter the subject number, and click Add Subject.
6. If the form contains an editable Visit Start 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.
7. Answer the questions on each form.

   Tip:

   For questions with a drop-down or checkboxes, you might be able to select more than one option, depending on the study protocol. On the right, below Question Hint, check if there are any instructions about the number of answers you are allowed to select.
8. Click Save, and then Screen, or click Save & Close to save your changes and screen later.
9. Note the Subject Number in the confirmation window.
10. Click Return to All Subjects to return to the list of subjects at the site or click Cancel to remain in the visit.