What actions impact subjects?

Depending on the protocol, site users can perform multiple actions that have an impact on a subject's state. Most of these updates appear in each subject's history, but do you know what each update means and what's the impact for every subject and the overall user interface?

What is an action? It's a task site users usually perform for subjects in order to collect and manage their data at a site during the study. From dispensing the right kits to a subject during a randomization visit to transferring or reinstating them, here are some of the actions that impact a subject's state.

Note:

For each action there's a corresponding update in Subject History that shows the date, time, and other specific details such as randomization numbers or site names.

Randomized

What it means: A subject has successfully completed a Randomization visit.

How this action impacts a subject's state: When a site user randomizes a subject, their state changes to Active.

Other changes: When a subject is randomized, this update shows up in Subject History, along with the randomization number, date, and time of the randomization visit.

Transferred

What it means: A subject was transferred from one site to another.

How this action impacts a subject's state: When a site user transfers a subject from site A to site B, the subject maintains whatever state they were in at site A. For example, a subject will keep their Active state after being transferred from one site to another.

Other changes: When a subject is transferred, this update shows up in Subject History, along with the site that the subject came from, and the date and time of the transfer.

Enrolled

What it means: A site user enrolled a subject in a rollover study.

How this action impacts a subject's state:

• After a site user screenes a subject in a study that doesn't contain a randomization (or baseline) visit.
• After a site user enrolls a subject in a rollover study, the subject remains in a state of Enrolled. In a rollover study, an enrolled subject is also active, so site users can start dispensing kits to them at any time.

Withdrawn

What it means: The subject is no longer available or eligible to continue participating in the study, so a site user withdrew them from the study.

How this action impacts a subject's state: When a site user withdraws a subject from the study, their state changes to Withdrawn.

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.

Other changes: When a subject is withdrawn from a study, this update shows up in Subject History, along with the date and time of the withdrawal.

Screen failed

What it means: The subject doesn't meet the screening criteria so either they can't complete their screening visit or a site user manually screen fails them.

How this action impacts a subject's state: When a site user screen fails a subject, their state changes to Screen Failed.

Note:

A subject who is marked as Active can no longer be automatically screen failed or manually screen failed by a site user.

Other changes: When a subject fails screening, this update shows up in Subject History, along with the date and time of the screen failure.

Reinstated (Undo Withdrawal)

What it means: A site user withdraw a subject in the study, but then brought them back into the study by undoing their withdrawal.

How this action impacts a subject's state: When a site user undoes the withdrawal of a subject in the study, they go back to the state that they had before being withdrawn.

Note:

Only subjects in an Active or New state can be withdrawn from a study.

Other changes: When a subject's withdrawal is undone, this update shows up in Subject History, along with the date and time of the action.

Reinstated (Undo Screen Failure)

What it means: A subject was automatically or manually screen failed by a site user, and now they're brought back into the study by being re-screened or by undoing their screen failure.

How this action impacts a subject's state: 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.

Other changes: When a subject's screen failure is undone, this update shows up in Subject History, along with the date and time of the action.

Reinstated (Undo Study Completion)

What it means: A site user marked a subject as Complete, but then brought them back into the study by undoing their study completion.

How this action impacts a subject's state: When a site user undoes a subject's study completion, they go back to the state that they had before being completed, such as Active.

Note:

A subject who is marked as Complete cannot be withdrawn from the study.

Other changes: When a subject's completion is undone, this update shows up in Subject History, along with the date and time of the action.