Database lock is the point at which a trial database is closed to further changes, after data cleaning is complete, so the final analysis can be performed on a fixed dataset. In blinded trials, unblinding follows lock.
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In short
Explained
Lock is the line between collecting data and analysing it. Once the database is locked and, in a blinded trial, treatment codes are released, any later change to the data invites the question of whether it was influenced by knowing the results. That is why lock is preceded by a formal checklist and approvals, and why unlocking requires a documented reason.
Most of the work happens long before lock. Studies that resolve queries as they arise, verify critical data continuously and reconcile safety data monthly reach lock in days; studies that leave cleaning to the end can take months. Good edit checks and risk-based monitoring shorten the path.
In Capture
Data managers freeze or lock a single field, a form or a whole set of subjects, in bulk. Unfreezing and unlocking need a reason from a set list, and every action lands in the audit trail. The status overview shows what is complete, missing or overdue, so the path to lock is visible.
The database is closed to changes after cleaning, coding and reconciliation are complete, so the final analysis runs on a fixed dataset.
A soft lock freezes data for final review with controlled changes still possible; a hard lock closes the database for analysis.
Yes, but only with a documented justification and approval, and the unlock and any changes are recorded in the audit trail.
It depends on how much cleaning is left at the end. Continuous cleaning during the study can shorten the time from last visit to lock to days.
Continuous cleaning, bulk freeze and lock. Free sandbox.