2 Manage subjects

  • Add and screen a subject
    Ready to screen a new subject? Here's where you start. Remember that this procedure doesn't apply to rollover studies. Subjects enrolled in a rollover study have already been screened in the original study, and don't need to be screened again in the rollover study.
  • Dispense kits after a titration error
    Maybe you tried to change the dose for one of the subjects in your study but it seemed like titration wasn't available. This could have happened because not enough time had passed after the last titration. If you don't know the minimum time between titrations, contact your Clinical Research Associate (CRA) or medical monitor. After enough time has passed, you can follow these steps to dispense kits.
  • 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.
  • 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.
  • 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.
  • Randomize a subject after Oracle Clinical One Platform didn't allow you to randomize
    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.
  • Cancel a subject
    Have you added a subject in error and would like to cancel it? You can cancel a subject as long as no data has been entered for it.
  • Re-sign a subject's data
    If a site user updates the answer to a question for a subject who is already signed, that subject becomes unsigned. To make sure the updated data is accurate, you need to re-sign a subject's data.
  • 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.
  • 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.
  • Sign at the form level
    If your study requires you to sign data for forms then you must perform this task to ensure that the data is accurate.
  • Sign at the subject level
    If your study requires you to sign data for subjects then you must perform this task to ensure that the data is accurate.
  • Sign at the visit level
    If your study requires you to sign data for visits then you must perform this task to ensure that the data is accurate.
  • 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, Oracle Clinical One Platform 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.
  • Update a subject number
    If you ever need to update a subject number, you can do so during the study conduct period.
  • 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.
  • What states can a subject have?
    Depending on the protocol, site users can update a subject's state through multiple actions for a number of times during the study. But have you ever wondered what each state really means for the way you manage subjects' data at a site?
  • After undoing the event I cannot complete or withdraw a subject
    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.