The database lock is frustrating for sponsors and CROs because it often leads to costly delays. The lock should not mean lockdown, though. The data produced via a clinical trial belongs to the study sponsor and team, so why the delays?
Understanding the Database Lock
The database lock system is a complex process, but a necessary industry standard. The locking function secures the data and ensures its quality by preventing further editing prior to submission to the Food and Drug Administration. The right electronic data capture system and provider, along with some common sense data management approaches are the keys to avoiding lockdown and the delays that come with it.
The database lock is one of the final steps taken during a clinical trial before submitting the information to the FDA. It is done after a final quality check and data validation, but before the data is extracted and formatted for submission. It is often the formatting process that leads to delays after the lock.
A properly organized clinical trial with a system and EDC support partner that helps ensure data maintenance and validation throughout the study changes the outcome of database lock. Ongoing management goes a long way in eliminating end of trial problems and database lock issues. By monitoring and validating data during the trial, you gain control over it, so you avoid last minute concerns.
The goal is to limit the changes made to the data and keep the database clean. Once the lock is secured, modifications are complicated, fully audited and only done in an emergency. Issues occur when the exported data is not formatted to work with other platforms or ready for submission. Some locks keep sponsors from even reviewing their own data to ensure it is prepared for FDA submission.
Why the Lock Often Leads to Lockdown
The EDC system should format data in a way that is useful after the study completes, as well. Some providers use a format that only works with their proprietary software, so data extraction becomes problematic. The data must be reformatted to prepare it for FDA submission. The flaw in this thinking is the idea that the data belongs to the EDC provider. When in fact it belongs to the sponsor or CRO and the format should reflect that. Data needs to be exported in a workable format and close to ready after the final validation.
Once validated, the data should be easy to export and work on any platform for review prior to submission, but that is not what most sponsors get from the average EDC provider. They have become accustomed to the delays associated with the database lock and preparation for FDA submission.
OmniComm, a true EDC partner, and our experienced team will work with the sponsor to manage the data throughout the study and then format it, so it is readable outside the system in order to reduce delays and re-formatting efforts. When extracted from the EDC software, the study data should be almost ready for submission, improving the lock process and saving the sponsor time.