What states can a subject have?

Depending on the protocol, site users can update a subject's state through multiple actions for a number of times during the study. But have you ever wondered what each state really means for the way you manage subjects' data at a site?

What is a state and what does it say about a subject? A state is an indicator that gives you a general view of where the subject is in the study. Have they just been added? Are they in the “waiting room”, ready to effectively enter the study? Are they active participants in the study? Have they left the study? These are just some of the questions a subject's state can answer.

Note:

A subject's state appears under a subject's ID, in the Subjects table. Information about subject states can also be found in the Subject Events report.

New

What it means: The subject has just been added to a study, but they weren't screened or randomized yet.

How a subject reaches this state: A site user adds a subject to a study but doesn't screen them yet.

Screened

What it means: The subject successfully completed the Screening visit and is ready to be randomized.

How a subject reaches this state: A site user successfully screens a subject during the Screening visit, without any errors appearing on any forms.

Active

What it means: The subject is an active participant in the study and data is collected on them.

How a subject reaches this state: A site user successfully randomized a subject during the Randomization visit, without any data collection or dispensation errors.

Screen failed

What it means: The subject doesn't meet the screening criteria and can't participate in the study.

How a subject reaches this state: A site user either:

• Tried screening the subject but forms for the Screening visit contained errors.
• Manually screen failed the subject. For example, a site user can manually screen fail a subject after they find out data from their screening form isn't correct.

Enrolled

There are different scenarios for how a subject reaches an Enrolled state:

What it means:

• The subject is an active participant in a rollover study.
• The subject was added in the study after being screened outside Oracle Clinical One Platform.
• The subject was screened in a study without a randomization (or baseline) visit.

How a subject reaches this state:

• The subject answered 'Yes' to the rollover type question that typically appears in the study completion form and was automatically enrolled from a baseline study to a rollover study.
• The site user clicked Add subject on the Subjects tab and the subject was automatically enrolled in the study after being screened in a different system.

Withdrawn

What it means: The subject is no longer available or eligible to continue participating in the study.

How a subject reaches this state: Typically, a site user manually withdrew the subject because they were no longer eligible or became unavailable to participate in the study. Additionally, a subject's state permanently changes to Withdrawn when a site user performs a code break on the subject, unblinding their results.

Complete

What it means: A subject has completed all visits, and all data has been entered for the subject.

How a subject reaches this state: A site user marked the subject as Complete after they completed all of their visits in a study. Once a subject’s state changes to Complete a site user can no longer save forms that weren't started, screen, randomize, withdraw or dispense kits to a subject.