Monitor subjects and sites
- 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. - 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. The only form item that you cannot freeze is the Visit Date field. - 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. - 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
If Source Data Verification (SDV) is required in your study, then you must perform this task to make sure the data collected during a study is accurate. - About Source Data Verification statuses
Depending on how your study has defined your Source Data Verification (SDV) settings, you can encounter different statuses and icons in subjects' questions, forms and visits. - 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. - 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.
Parent topic: Work during the study conduct period