Recruiter's Glossary

Examples: Phase I • Phase II • Risk-Based Monitoring

Database Lock

Term from Clinical Trials industry explained for recruiters

Database Lock is an important milestone in clinical trials where all the collected patient information is finalized and made unchangeable. Think of it like sealing an envelope - once it's sealed, nobody can modify the contents anymore. This process ensures that the trial data remains trustworthy and reliable for final analysis. It's a crucial step that happens near the end of a clinical trial, before researchers start analyzing results. The term might also appear as "data lock" or "database freeze" in job descriptions. This process is required by regulatory agencies like the FDA to ensure the integrity of clinical trial results.

Examples in Resumes

Managed Database Lock processes for 5 Phase III clinical trials

Coordinated with data managers to achieve clean Data Lock within project timelines

Successfully completed Database Freeze procedures for 12 international studies

Typical job title: "Clinical Data Managers"

Also try searching for:

Clinical Data Manager Clinical Database Manager Clinical Data Associate Data Management Specialist Clinical Research Associate Clinical Trial Manager Clinical Data Coordinator

Where to Find Clinical Data Managers

Professional Organizations

Online Communities

Job Boards

Example Interview Questions

Senior Level Questions

Q: How do you handle timeline pressures when working towards database lock?

Expected Answer: Should discuss strategies for managing multiple stakeholders, prioritizing critical issues, and maintaining quality while meeting deadlines. Should mention experience with contingency planning and resource allocation.

Q: What steps do you take to ensure data quality before database lock?

Expected Answer: Should explain the process of reviewing data, resolving queries, ensuring all required documentation is complete, and coordinating with different departments to maintain data integrity.

Mid Level Questions

Q: What are the key requirements that must be met before proceeding with database lock?

Expected Answer: Should mention completion of data entry, resolution of queries, quality control checks, and obtaining necessary approvals from study team members.

Q: How do you communicate database lock procedures to study sites?

Expected Answer: Should discuss creating clear timelines, providing guidance documents, coordinating with sites for final data entry, and ensuring all stakeholders understand their responsibilities.

Junior Level Questions

Q: What is database lock and why is it important?

Expected Answer: Should explain that database lock is the process of finalizing clinical trial data to prevent further changes, ensuring data integrity for analysis and regulatory submission.

Q: What documentation is typically required for database lock?

Expected Answer: Should mention basic requirements like completed case report forms, resolved queries, signed investigator statements, and quality control checks.