Understand subject events and their impact

Depending on the protocol, site users can perform multiple actions for a subject that have an impact on their state. These actions are known as subject events and most of them appear in each subject's history

A subject event is an action applied on the subject that site users perform, either as part of a specific type of visit, or from the Manage drop-down in the Subjects page. Some events that are manually applied on the subject may trigger specific types of unscheduled visits (if included in the study design). For more information on visit types, see Understand visit types.

Here are the details of the most common subject events:

Subject event	Description	Impact on subject state	Impact on Subject History
Add (New Subject)	A new subject is added to a study. Depending on your study's settings, subjects can be added and subsequently screened, or they can be directly screened as the first step to become part of the study. If subject number is configured to be assigned when adding a subject, then adding a subject is the first step to add a subject in the system. For more information see Add a subject to a study. If you add a subject in error, you can undo this action. See Cancel a subject.	The subject becomes New.	This event does not show up in the Subject History.
Screen	The subject completes the screening visit and enters a screening period. This occurs upon selecting the Screen button in a Screening type visit. Depending on your study's settings, subjects can be added and subsequently screened, or they can be directly screened as the first step to become part of the study. If subject number is configured to be assigned when screening a subject, then screening a candidate is the first step to add a subject in the system, and the subject never goes under the state of New. For more information see Add a subject to a study. If your study allows it, subjects can be rescreened after screen failure. This is considered a normal screening event. See Rescreen a subject.	The subject becomes Screened. Note: in Oracle Clinical One Analytics this state displays as Screening_initiated.	When a subject is screened, this event shows up in the Subject History as Screened along with the screening date.
Screen Fail	The subject doesn't meet the screening criteria so, either they can't complete the screening visit (due to validation rules), or a site user manually screen fails them afterwards. See Screen fail a subject. Note: Once subjects moves to a state of Active or Enrolled, they cannot be screen failed. However, you can undo a subject's enrollment so that the option to Screen Fail is back available.	The subject becomes Screen Failed.	When a subject fails screening, this event shows up in Subject History as Screen Failed, along with the reason for screen fail (either provided by the site user or due to validation failure) and the date of the screen failure.
Reinstated (Undo Screen Failure)	After a subject was automatically or manually screen failed by a site user, they can be brought back into the study by being re-screened or by undoing their screen failure. If a subject is rescreened, this counts as a normal screening event (see above). If the Screen failure is undone, the subject is considered reinstated. For more information, see Undo or edit a subject's screen failure.	When a site user undoes the screen failure of a subject in the study, they go back to the state that they had before failing the screening: If they automatically failed screening due to errors in a form, they go back into a Screened state. If they were previously manually screen failed by a site user, they go back into a New state.	When a subject's screen failure is undone, this event shows up in the Subject History as Undo Screen Fail, along with the provided reason and the date and time of the action.
Enroll	Only applicable in studies that don't include randomization. The moment when a subject is enrolled depends on the study and its design: 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.	The subject becomes Enrolled. In a rollover study, an Enrolled subject is also Active, so site users can start dispensing kits to them at any time. Note: For studies with randomization, after the screening visit when randomization occurs, subjects go to Active state instead of Enrolled.	When a subject is enrolled, this event shows up in the Subject History as Enrolled along with the enrollment date.
Reinstated (Undo Enrollment)	There might be cases in which you need to undo a subject's enrollment, for example if the subject needs to be screen failed. See Undo a subject's enrollment.	The subject goes back to the state that they had before enrollment.	When a subject's enrollment is undone, this update shows up in Subject History as Undo Enrolled, along with the provided reason, and the date and time of the action.
Randomize	The subject successfully completes a visit with randomization. This occurs upon selecting Randomize in a visit with randomization. See Complete a randomization or dispensation visit. If you randomized a subject in error, see Mange subjects randomized in error.	The subject becomes Active.	When a subject is randomized, this event shows up on the Subject History sidebar as Randomized, along with the randomization number, and the date and time of randomization.
Transfer	The subject is transferred from one site to another. See Transfer a subject.	When a subject is transferred to a new site, the subject maintains whatever state they had at the original site.	When a subject is transferred, this event shows up in Subject History as Transferred, along with the date and time of the transfer, the site that the subject came from, and the site that the subject was transferred to.
Withdraw	A site user withdraws a subject from the study. A withdrawn subject is no longer available or eligible to continue participating in the study. See Withdraw a subject. Note: A subject who is marked as Complete cannot be withdrawn from the study.	The subject becomes Withdrawn.	When a subject is withdrawn from a study, this event shows up in Subject History as Withdrawn, along with the reason and date of the withdrawal.
Reinstated (Undo Withdrawal)	A withdrawn subject is brought back into the study by undoing their withdrawal. See Undo or edit a subject's withdrawal. Note: If a site user performs a code break on a subject, and chooses to withdraw that subject after unblinding their details, that subject's withdrawal can no longer be undone.	The subjects goes back to the state that they had before being withdrawn.	When a subject's withdrawal is undone, this update shows up in Subject History as Undo Withdraw, along with the provided reason, and the date and time of the action.
Code Break	You perform a code break on a subject to unblind their treatment arm details. 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).	If the subject is withdrawn from the study as part of the code break, the subject becomes Withdrawn.	The Code Break event does not show in the Subject History. However, if the subject is withdrawn from the study as part of the code break, the Withdrawn event is listed (see above).
Complete	A site user marks a subject as complete after the subject has concluded all required visits, all data has been entered for the subject, or has been screen failed. See Mark a subject as complete. If the study includes a Study Completion type of visit, this visit opens upon marking the subject as complete.	The Subject becomes Complete.	When a subject completes the study, this event shows up in the Subject History as Study Completed, along with the date of completion.
Reinstated (Undo Study Completion)	The complete subject is brought back into the study by undoing their study completion. See Undo or edit a subject's completion of a study.	The subject goes back to the state they had before being completed, such as Active or Enrolled.	When a subject's completion is undone, this update shows up in Subject History as Undo Study Complete, along with the reason provided, and the date and time of the action.