An overview on subject number assignment

Your study can assign subject numbers either when you add a subject or after you complete the screening visit. This setting determines how subject numbers are assigned and directly impacts the subject creation workflow, when subject data becomes available in reports, and the system’s behavior if screening is cancelled.

Why this matters

Understanding the differences in how subject numbers may be assigned in a study can help you set the right expectations for what data you will see in your study after adding or screening a subject.

If your study assigns a subject number when you add the subject to the study, that subject can appear on the Subjects page with one of the following statuses:

New: The subject isn't screened yet
Screened: When the screening is successful
Screen Failed: Manual or automatic failure
Enrolled: Added in your study but screened in a system other than Oracle Clinical One Platform

As soon as you add the subject, their status, assigned number, and any related data appear in the User Interface (UI), reports, and archives (where applicable).

If your study assigns a subject number only after completing the required Screening visit, the subject can appear on the Subjects page with one of the following statuses:

Screened: When the screening is successful
Screen Failed: Automatic failure

In this setup, the subject data is saved and appears in reports and archives only after the subject number is assigned regardless of the screening outcome (whether it succeeded or failed).

How to tell which workflow your study uses

Subject number is assigned when adding a subject	Subject number is assigned after screening
On the Subjects page, select Add Subject to include the new subject in the system and start the first visit scheduled in your study; this may or may not be the screening visit. You collect screening data and select Screen. The subject number is assigned as soon as you add the subject into the study. If you select Cancel or leave the Screening visit, the already collected data is saved and stored, the subject remains in the system with an associated number, and a status of New. After you screen the subject, its status is displayed as either Screened or Screen Failed. Its associated data is displayed in the applicable reports and integrations.	On the Subjects page, select Screen Candidate to start the Screening visit; this is the first required visit in the study. You collect screening data and select Submit. The subject number is assigned only after you submit the screening forms, whether the subject passes or fails screening. If you select Cancel or leave the Screening visit, no data is saved, the subject isn't added to the system, and no subject number is assigned. After completing the screening visit, the subject is added to the study with an associated number (whether manually or automatically assigned), and a status of either Screened or Screen Failed. Its associated data is also displayed in the applicable reports and integrations.

Subject number is assigned when adding a subject

Subject number is assigned after screening

On the Subjects page, select Add Subject to include the new subject in the system and start the first visit scheduled in your study; this may or may not be the screening visit.
You collect screening data and select Screen.

The subject number is assigned as soon as you add the subject into the study.

If you select Cancel or leave the Screening visit, the already collected data is saved and stored, the subject remains in the system with an associated number, and a status of New.

After you screen the subject, its status is displayed as either Screened or Screen Failed. Its associated data is displayed in the applicable reports and integrations.

On the Subjects page, select Screen Candidate to start the Screening visit; this is the first required visit in the study.
You collect screening data and select Submit.

The subject number is assigned only after you submit the screening forms, whether the subject passes or fails screening.

If you select Cancel or leave the Screening visit, no data is saved, the subject isn't added to the system, and no subject number is assigned.

After completing the screening visit, the subject is added to the study with an associated number (whether manually or automatically assigned), and a status of either Screened or Screen Failed. Its associated data is also displayed in the applicable reports and integrations.

Related Topics

Parent topic: Add a subject to a study