Understand the different subject states

Site users perform different actions to subjects along the study, called subject events, that reflect on the subjects' state. A state is an indicator that gives you a general view of where the subject is in the study, and the available subject states depend on the study protocol.

For more information on subject events, see Understand subject events and their impact.

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.

Table 2-1 Subject statuses

Subject status	Description
New	The subject has just been added to a study, but they weren't screened or randomized yet.
Screened	The subject successfully completed the Screening visit and is ready to become part of the study, either to be enrolled or randomized.
Active	The subject is successfully randomized during the Randomization visit, without any data collection or dispensation errors, and so becomes an active participant in the study.
Screen failed	The subject doesn't meet the screening criteria and can't participate in the study. Subjects can be screen failed during a screening visit, upon failing defined validations, or they can be manually screen failed by site users. For example, a site user can manually screen fail a subject after they find out data from their screening form isn't correct. Note: Subjects can only be screen failed before randomization or enrollment, depending on the study. If the subject is already randomized but shouldn't have, see Mange subjects randomized in error. In studies without randomization, if subject is already enrolled, you can undo a subject's enrollment so that the option to screen fail is back available.
Enrolled	Only applicable in studies that don't include randomization. There are different scenarios for how a subject reaches an Enrolled state: If the visit schedule includes an Enrollment type visit, enrollment occurs only after completing the enrollment visit. This occurs upon selecting the Enroll button in an Enrollment type visit. If the visit schedule does not include an Enrollment type visit, a subject is automatically moved from a status of Screened to Enrolled when they complete the visit following the Screening type visit. In rollover studies, where subjects are screened in an external system, subjects are automatically enrolled when added. See Enroll a subject in a rollover study.
Withdrawn	The subject is no longer available or eligible to continue participating in the study. Typically, a site user manually withdraws the subject because they are no longer eligible or became unavailable to participate in the study. Simmilarly, depending on your study's protocol and settings, Clinical One Cloud Service might automatically withdraw the subject. For more information, see Unblind a subject's treatment arm (code break).
Complete	A subject has completed all visits, and all data has been entered for the subject. 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. However, you can Undo or edit a subject's completion of a study.