An Introduction to The Database Lock Process in Clinical Trials [Video]

Database lock is a critical milestone in clinical trials, marking the point when all trial data is complete, cleaned, validated, and formally closed for analysis. In this video, we’ll explain the difference between soft and hard locks, walk through the key criteria that must be met before lock, and outline the roles each team plays in getting there. You’ll learn best practices for planning from study start, maintaining data quality throughout the trial, and avoiding common pitfalls that can delay lock and analysis.

At Quanticate, our data management, biostatistics, and clinical operations teams work together to deliver smooth, audit-ready database locks that meet global regulatory requirements. From defining lock criteria in the data management plan to coordinating soft-lock reviews, resolving final queries, and securing sign-offs, we help sponsors achieve efficient, compliant close-outs that keep timelines on track. Submit an RFI today.