Lock a subject

Sponsor users can lock a subject to prevent any user from making further changes to that subject.

Sponsor users assigned the Lock Subject Data Entered at a Site permission can lock an entire subject to prevent users from adding new or updating existing data for that subject, including:

• New visits and events (Scheduled or unscheduled)
• Signing
• Verifying
• Freezing
• Unfreezing
• Screening
• Randomization
• Transfer
• Withdrawal
• Completion
• Dispensation
• Changing a subject's number
• Data entering or API loading data
• Running programmable rules

Users assigned the Lock Subject Data Entered at a Site permission can also unlock a subject.

Details for sponsor users

As a sponsor user, here's what you should be aware of when it comes to your workflow:

• Subject locking is available in Testing, Training, and Production mode.
• On the Subjects page, under the View filter, you can now select Locked or Unlocked to view any locked or unlocked visits for subjects.
• On the Subjects page, a lock icon () appears next to the subject, indicating that it is locked, along with a Subject Locked status in the Subject History side panel.

  Note:

  While subject locking is in progress, the Subject Locked status will not be reflected in the subject's history until the lock action has completed.
• When unlocked, an icon () appears next to the subject, along with a status of Subject Unlocked in the subject's history.
• Locking all subjects at a site does not prevent additional subjects from being added. On the Sites page, the Add Subjects option must be set to Off to disallow users from adding additional subjects.
• A subject can be locked even if there are incomplete visits or open queries for that subject.
• When a subject is locked and any data is unlocked at the visit level, the subject's status will update to Subject Unlocked.
• If all data is locked at the visit level, the subject is locked at the casebook level.
• When a subject is locked, the subject's existing data becomes read-only.
• Existing data remains signed, verified, and frozen as it was prior to the subject lock.

More information and step-by-step instructions on subject locking can be found in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Details for site users

Site users can view the statuses for locked and unlocked subjects, so long as they have the corresponding permissions to see that element.

• A lock icon () appears next to a subject, along with a status of Subject Locked in the Subject History, indicating the subject has been locked by a sponsor user.
• An unlocked icon () appears next to a subject, along with a status of Subject Unlocked in the Subject History, indicating the subject has been unlocked by a sponsor user.

Impact on reports

Updates to the Subject Events Report can be found in the Reporting Guide after the RAE upgrade.

Already working in a live study?

At the time of the RAE upgrade, if all visits are locked, you will still need to explicitly lock the subject in order for the subject to be considered locked. It will also be possible to lock or unlock a subject that was entered in a study prior to this upgrade.

Additional information on subject locking can be found in the Sponsor and CRO User Guide after the RAE upgrade.