Understanding the subject locking process

Subject locking is a process designed to protect your clinical data by preventing any further changes once all required data for a subject has been collected and reviewed. This ensures the integrity of study data and helps maintain compliance with regulatory standards.

How the subject locking process works

When attempting to lock an entire subject, the application evaluates the locking status in an aggregate way: if all questions on a form are locked, the form is considered locked; if all forms in a visit are locked, the visit is considered locked; if all visits for a subject are locked, the subject is considered locked.

After a subject is locked, no further changes can be made to their data unless the subject is intentionally unlocked by an authorized user. Alternatively, an authorized user could also unlock specific questions for editing specific data points. A site user is no longer allowed to start new visits or collect data in forms for that subject. Subject-level operations - such as queries or data corrections - are prevented unless one or more questions, forms, visits, or the subject, is unlocked.

This aggregate locking process represents a key function of locking subjects:

• It prevents unintended data entry - locking is a deliberate control mechanism.
• It protects data integrity - locked subjects cannot be changed unless manually unlocked.
• Controls visit display - once a subject is locked, any visits that have not yet been started are hidden from the User Interface (UI), and no additional visits can be added.

Lock level	Description
Question level	Each question in a form is assessed for current locking status, based on what the user chooses to lock. Questions ca be locked individually or in groups. Once all questions in a form are locked, the entire form is locked. A question can be locked manually by a sponsor user or it can be automatically locked by an Auto-lock rule.
Form level	Forms can be locked individually or in groups. Once all questions on a form are locked, the form is considered locked.
Visit level	Visits can be locked individually or in groups. Once all forms on a visit are locked, the visit is considered locked.
Subject level	Subjects can be locked individually or in groups. Once all visits for a subject are locked, the subject is considered locked. If a subject includes not-started visits when it is locked, those visits will be hidden on the UI.