According to theGood Clinical Data Management Practices (GCDMP), thedatabase lock (DBL)process signifies the formal closure of the clinical trial database, ensuring that no further changes can be made to the data before statistical analysis. This process must be documented, controlled, and approved by key study stakeholders to ensuredata accuracy, completeness, and readiness for analysis.
The GCDMP specifies that database lock should occur only after all data cleaning, discrepancy resolution, and reconciliation activities are complete. The lock authorization typically requires the approval of theClinical/Scientific Representative (to confirm clinical completeness), the Data Manager (to confirm data integrity and query closure), and the Biostatistician (to confirm readiness for statistical analysis).
This tri-party approval ensures that the database reflects final, verified data consistent with the clinical protocol, and that the statistical analysis dataset derived from the database is accurate and auditable. The approval process is documented via aDatabase Lock Authorization Form or Sign-off Log, which becomes part of the permanent trial master file (TMF).
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 7.1 – Lock Procedures and Approvals
ICH E6 (R2) GCP, Section 5.5.3 – Data Handling and Record Keeping
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Section on Database Closure
