Guided Notes
Database Lock, Unblinding & Unlock
Planning lock from day one, soft vs hard lock, the lock checklist, approvals, removing write access, unblinding, post-lock findings and the unlock/relock process.
What database lock means
Slide 1 / 5Database lock (DBL) is the point when data is declared final for analysis: write access is removed, and the dataset used for the primary analysis is fixed. • Soft lock / freeze: data frozen for review, still changeable with permission. • Hard lock: no changes without formal unlock. • For blinded studies, unblinding happens only after lock — protecting against bias.