Database lock (DBL)

Definition:

Finalization of information (data sets) obtained in a clinical trial.

After data collection has been completed in a clinical study, including follow up of all participants, data quality and validation exercises are undertaken. After this, the database is “locked” so no further changes can be made to trial data. Data are then extracted from the database for analysis.

Database lock is a crucial point in a clinical trial. It is intended to protect and maintain the integrity of trial data.