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?
An action is a task that 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.| Subject status | What it means | How this action impacts a subject's state | Other changes |
|---|---|---|---|
| Randomized | A subject has successfully completed a Randomization visit. | When a site user randomizes a subject, their state changes to Active. | When a subject is randomized, this update shows up on the Subject History sidebar, along with the randomization number, date, and time of the randomization visit. |
| Transferred | A subject was transferred from one site to another. | 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. | 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 | A site user enrolled a subject in a rollover study. |
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. |
None. |
| Withdrawn | The subject is no longer available or eligible to continue participating in the study, so a site user withdrew them from the study. | When a site user withdraws a subject from the study, their state
changes to Withdrawn.
Note: f 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. |
When a subject is withdrawn from a study, this update shows up in Subject History, along with the date of the withdrawal, whether specified by default or subsequently edited by a site user. |
| Screen failed | 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. | 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. |
When a subject fails screening, this update shows up in Subject History, along with the date of the screen failure, whether specified by default or subsequently edited by a site user. |
| Reinstated (Undo Withdrawal) | A site user withdraw a subject in the study, but then brought them back into the study by undoing their withdrawal. | 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. | 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) | 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. | 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:
|
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) | A site user marked a subject as Complete, but then brought them back into the study by undoing their study completion. | 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. |
When a subject's completion is undone, this update shows up in Subject History, along with the date and time of the action. |
Parent topic: Subjects and visits FAQs