Contributing experts at Medrio: Rod McGlashing, Data Science Subject Matter Expert, and Muhammad Bilal, Vice President of Data Sciences
The race to database lock in a clinical trial brings constant pressure. A slow database lock can delay study timelines and push back key milestones. Stakeholders grow frustrated, and costs start to rise.
Study teams often deal with challenges getting to database lock, or DBL, in a clinical trial. Obstacles to clinical study closeout may include missing data, unanswered queries, and site delays.
But this process doesn’t need to be a nightmare—there are several ways to achieve database lock faster.
In this blog, we’ll discuss the:
- Definition of a database lock
- Main purpose of database lock
- Activities after database lock in clinical trials
- Best practices to support faster clinical study closeout
- Support Medrio provides for study closeout
- Frequently asked questions (FAQ) about database locks
Looking for more detailed information on how to expedite database lock? Check out our clinical trial database lock guide.
What is Database Lock in Clinical Trials?
A database lock (DBL) marks when a clinical trial’s database is closed to any further changes.
The DBL process involves reviewing and finalizing every data point for every patient across all visits. Once locked, no new data can be entered, and existing data cannot be altered.
What is the Main Purpose of Database Lock?
The primary purpose of a DBL is to preserve data integrity. By ensuring the dataset is complete, accurate, and unaltered after locking, the results of the study remain reliable and consistent.
What Happens After Database Lock in Clinical Trials?
After database lock, the data is sent to the biostatistician for analysis. Then, the data goes to the medical writer for clinical study report (CSR) writing. Finally, it is submitted for regulatory review.
The locked database is the foundation for all subsequent statistical analyses. Its integrity is critical to accurately interpreting the study’s outcomes.
Clinical Trial Database Lock Checklist
Develop a detailed standard operating procedure (SOP) for database lock to define roles, responsibilities, and workflows. SOPs combined with a Data Management Plan (DMP) provide a clear roadmap for DBL and can limit last-minute scrambling.
Outlining a structured workflow gives clear guidelines to everyone involved so they know their role in the process, allowing for a seamless transition from data collection to analysis and reporting.
A clinical trial database lock checklist should include:
Note that this list is not all-encompassing. Certain organizations or processes may require additional/different steps.
Best Practices to Support Faster Clinical Study Closeout
Getting to the last patient last visit, or LPLV, in clinical trials is just the start of the study closeout process. Afterward, much work must be done to get to database lock.
Best practices for getting to database lock include:
- Cleaning data and resolving queries throughout the study
- Engaging biostatisticians
- Activating SOPs
- Maintaining a clear audit trail
Learn about the other 4 best practices to consider in our database lock eBook.
Clean data and resolve queries throughout the study
Ongoing data cleaning—subject by subject, visit by visit—is crucial to preparing for a successful database lock.
- Close out queries as you go to address any errors or inconsistencies early. This approach reduces the risk of analyzing “dirty” data, which can lead to unreliable results and major delays.
- Do ongoing data reconciliation. For example, cross-check labs, EKGs, and other critical data points. This approach maintains both accuracy and completeness.
- Address discrepancies in real time. This approach reduces the go-to-market timelines for your new therapy or treatment.
The bigger the trial, the more time and effort you save by using an incremental cleaning and lock process. The result is fewer delays, less scrambling, and a much faster final database lock.
Engage biostatisticians early and often
One of the main ways to avoid unlocking a database is to communicate with biostatisticians early.
Data Management teams should communicate with Biostatistics teams about:
- Protocol amendments
- Electronic Case Report Form (eCRF) updates
- Data export formatting, including subgroup variables for filtering
Failure of Data Management teams to meet regularly with Biostatistics teams can quickly create problems. These functional groups can collaboratively review and discuss data quality, study protocol changes, and data analysis formatting.
Ready to optimize your data management? Learn more about our clinical data management services.
Activate SOPs for database lock
Once the database is ready for lock, it needs to pass through the chain of responsibility defined in your SOP. This process ensures you meet all criteria for a clean, accurate, and complete dataset.
Before database lock, it is important to:
- Notify all team members
- Remove any access that allows database changes
- Document all lock procedures
Outlining a structured workflow gives clear guidelines to everyone involved. People will know their role in the process, allowing for a seamless transition from data collection to analysis and reporting.
Roles likely to be called into action at the time of DBL include:
- Data Managers verify that all data is properly entered and validated.
- Biostatisticians prepare for statistical analyses so that the data is set up for accurate interpretation.
- Medical Writers receive the locked data to begin drafting clinical study reports and other necessary documentation.
Your SOP should also outline policies and procedures for database unlocking if one is required.
Maintain a clear audit trail
Regulatory agencies require that data submitted for approval come from a locked and validated database.
The audit trail must document:
- When the database was locked
- Who authorized the lock
- What key activities occurred
This level of transparency reassures regulators that the data’s integrity is intact, which is a critical factor in the approval process. Without a properly maintained audit trail, the validity of the data—and the entire study—can come into question during regulatory inspections.
The audit trail proves to regulators that the results are based on finalized data, without any post-hoc changes or modifications.
Looking for technology that can support speedy database lock? Explore Medrio CDMS/EDC.
How Medrio Supports Study Closeout
Database lock and study closeout can be stressful processes. Medrio helps with this process by empowering sponsors and CROs with the technology and knowledge for success.
On average, Medrio Phase I and II clients get to database lock in just 13 days, while the industry average is 37 days.
Our configurable technology and data management expertise create the perfect storm for efficient study closeout and quality data outputs.
Want to discover how Medrio can help you with database lock? Schedule a demo.
Database Lock Clinical Trial Frequently Asked Questions (FAQ)
Common database lock clinical trial questions.
How long does it take to lock a database?
The industry standard is four weeks from the last patient last visit (LPLV), though early planning can help meet or reduce this timeline.
Can a database be unlocked?
Yes, but only if necessary. Unlocking allows for corrections but is a controlled process to protect data integrity.
What happens after the database is locked?
The data is sent to the biostatistician for analysis, then to the medical writer for clinical study report (CSR) writing and finally for regulatory submission.
How can you speed up the database lock process?
Start cleaning data early and use incremental or interim locks for completed subjects/sites. Regular data reconciliation helps avoid last-minute issues.
What should you do if a site still needs to submit the required data before database lock?
Work closely with the site to resolve missing data. If necessary, escalate the issue to ensure you meet timelines.
What is the role of PI approval in database lock?
PI approval is required from all sites before the database can be locked. Ensure all sites are aligned to avoid delays.
Can you partially lock a database during an ongoing study?
Yes, through incremental or interim locks. These allow you to lock data for completed subjects or visits without affecting the rest of the study.
How do you ensure data integrity in a clinical trial?
Data integrity is maintained through rigorous site training, data validation, ongoing monitoring, and audit trails. Using edit checks, query resolution, and risk-based monitoring helps catch errors early. A secure database lock process ensures the final dataset is accurate, complete, and unaltered.
