2 Manage subjects
- 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 - 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. - Add a subject to a study
Depending on your study's settings, the subject number that identifies a subject as part of the study can be assigned at different moments: when adding a subject or when screening a candidate. This setting determines the specific workflow to add a subject to the study in Clinical One Cloud Service. - Remove a subject (Undo Add)
If you add a subject in error, you can remove them as long as no data has been entered for them. - Screen fail a subject
If a subject has already been screened but is actually ineligible for the study, or becomes ineligible for the study prior to randomization, you can manually mark the subject as screen failed. - Undo or edit a subject's screen failure
If you screen failed a subject error, you can undo this action. You can also edit a subject's date of when their screen failure occurred, and their reason for screen failure. - Rescreen a subject
In some cases, your study's protocol may call for allowing subjects to be rescreened. For example, a subject may not have met study protocol requirements at the time of their initial screening, but may meet the requirements at a later time. - Enroll a subject
Enroll a subject that has been successfully screened as is ready to be an active participant in the study. The moment and workflow to enroll a subject depends on the study design and protocol. - Enroll a subject in a rollover study
Enroll a subject in a rollover study by answering the rollover question, typically included in the Study Completion Form in the original study. After enrolling a subject, they're marked as Enrolled in the rollover study, while also keeping their original subject number. In the rollover study, you can dispense kits, devices or perform dose changes for subjects. - Undo a subject's enrollment
Revert a subject's enrollment status back to Screened. - Update a subject number
If you ever need to update a subject number, you can do so during the study conduct period. - Randomize a subject after randomization error
You might need to randomize a subject again if you weren't able to randomize during the original visit, such as if your site was out of stock for the required kit. - Rollback a subject's last dispensation
Rollback a subject's dispensation to correct errors or reschedule a subject's visit - Mark a visit that a subject misses as skipped
Depending on how a study is set up, you might be able to skip a visit that a subject misses. You can always skip an optional visit. - Start a dynamic visit for a subject
If available in your study, by giving a certain answer to a question in a form, you may determine the display of a dynamic visit for a subject. - Unblind a subject's treatment arm (code break)
You unblind a subject's treatment arm by performing a code break. Depending on the study protocol, Clinical One Cloud Service might automatically withdraw the subject, and you might be required to complete a Withdrawal visit. Whether a subject is withdrawn is a study-specific setting. If you're not sure whether a subject will be withdrawn, contact your clinical research associate. - Mark a subject as complete
Mark a subject as complete after the subject has concluded all visits, all data has been entered for the subject, or has been screen failed. - Undo or edit a subject's completion of a study
If you marked a subject as Complete in error or an additional visit was included in the study's schedule, you can undo the action. Additionally, you can also edit a subject's study completion date. - Update a Screening or Enrollment date
Modify system assigned dates for screening and enrollment when needed. - Withdraw a subject
You can withdraw a subject at any time if the subject is no longer available or eligible to continue in the study, including if they failed screening. The same applies to subjects in a rollover study. - Undo or edit a subject's withdrawal
If you withdrew a subject in error, you can undo the action. However, if the subject was automatically withdrawn due to a code break, you can't undo the withdrawal. - Complete or withdraw a subject after undoing a previous complete or withdraw event
After undoing a subject's withdrawal or study completion, their associated visits remain in the schedule until you clear their data. To withdraw or complete the subject again, saving and closing these visits won't update their status. - Link subjects for Electronic Health Record (EHR) data import
With just a few clicks, you can link a subject to their Medical Record Number (MRN) in preparation to import their EHR data, removing the need for redundant data entry.