Start with adding a subject

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

If subject numbers are assigned upon screening a subject, see Start with screening a candidate.

To understand the differences in how subject numbers may be assigned in your study, see An overview on subject number assignment.

Note:

Subjects that are added into Oracle Clinical One Platform after they were previously screened outside of Oracle Clinical One Platform will be included in the study with a status of Enrolled. If the study includes a required Screening visit, you will need to re-screen the subject.
When your study assigns subject numbers upon adding a subject, consider the following:
  • Depending on how screening visits are configured, you may be able to answer specific required questions in order to progress with your subject's screening. For more information, see About required questions for Randomization and Trial Supply Management (RTSM) events.
  • 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.
  • A two-section form is considered complete if you answer all required questions in the first section and there are no incomplete table rows in the second section. The form is incomplete if there are any unfinished table rows in the second section.
  • You cannot apply data flags to screening questions. For more information, see Apply a data flag to a question.
  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 Add Subject.
  5. If entering subject numbers is required, on the Add Subject dialog, select the appropriate site, enter the subject's number, and select Add Subject.
  6. 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.
  7. Answer the questions on each form.
  8. Select Save, and then Screen.
    You can select Save & Close to save your changes and screen later.

    Tip:

    If you select Return to All Subjects or Save & Close during screening, the collected data is saved and the subject is added into the system with a status of New.
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 Return to All Subjects to go back to the Subjects page and start the subject's next visit, if applicable.
  • Automatically failed screening: If required, you may have to complete a visit related to the subject's screen failure.

    If applicable, you can manually screen fail the subject later.

Related Topics

Parent topic: Add a subject to a study