Monitor subjects and sites

• Find incomplete visits
  A visit is marked as incomplete if the visit window passes or if a subject arrives within the visit window but the site user doesn't complete the required questions associated with the visit. An incomplete visit means that screening, randomization, or dispensation didn't occur. This procedure also applies to rollover studies.
• Lock a subject at the form or visit level
  Sponsor users can lock forms and visits to prevent users from editing subject data.
• Unlock a subject at the form or visit level
  Sponsor users can unlock forms and visits to allow users to modify subject data.
• Lock a subject at the casebook level
  Lock a subject's casebook to prevent users from adding new or updating existing data for that subject.
• Unlock a subject at the casebook level
  Unlock a subject at the casebook level to allow users to add new or update existing data for a subject that has been previously locked.
• Freeze and unfreeze data
  As a data manager or CRA, you can prevent site users from editing case form data, to use it in data extracts and analysis. You can freeze data at a visit, form, and question level. Site users can only update a question after you unfreeze it.
• Filter subjects in a study
  Subject filters are located at the top of the subjects table. You can use these filters individually or in a combined way.
• Manage site permissions
  You can limit the activities a site user can perform, such as adding new subjects, screening and randomizing subjects or dispensing kits.
• Verify that a site has been activated
  If you're troubleshooting site or inventory issues, you might need to verify that a site has been activated. On the Sites tab, a green icon next to the site name means the site has been activated. This procedure also applies to rollover studies.
• Reveal a subject's treatment arm
  Oracle Clinical One Platform does not automatically withdraw subjects that have been unblinded with a code view. After you reveal a subject's treatment arm, you can perform the code view as many times as necessary to retrieve the unblinding results again. This procedure also applies to rollover studies.
• Re-verify a subject's data
  If a response to a question is updated on a form or visit that is already verified, that form or visit becomes unverified. In order to perform source data verification, you have to re-verify that form or visit.
• Review the data collected for a subject
  You can review the data entered for a subject and the history of events that have occurred for the subject. This procedure also applies to rollover studies.
• Verify a subject's data at a form and question level
  If source data verification is required in your study, then you must perform this task to make sure the data collected during a study is accurate.
• Transfer a subject
  When a subject is transferred, the subject number doesn't change. The site that the subject is transferred to can view and edit all subject data, including data that the subject's previous site entered. The site that the subject is transferred from can no longer edit any data for the subject. This procedure also applies to rollover studies.
• Verify that a site received a shipment
  If the site received the shipment, but did not register it as received in Oracle Clinical One Platform, the site won't be able to dispense the kits in the shipment, and the site may appear to be out of stock when there are kits available at the site. This procedure also applies to rollover studies.
• What if a site user randomized a subject in error?
  The following workflows provide suggestions for rectifying possible user errors. We recommend confirming that these measures are consistent with your organizational policies and processes.