Abstract
This is an accepted article with a DOI pre-assigned that is not yet published.
A database lock (DBL) represents a key milestone in the clinical trial lifecycle. In order to maintain data integrity, study databases must be locked before providing any statistical analyses/results for decision making and/or for submission to regulatory bodies. This chapter provides requirements, and best practices to successfully lock a study database including but not limited to project management, checklist(s) and access control. To maintain data integrity post-lock, careful decision-making and documentation should be in place if critical data needs to be updated.
Topics such as managing electronic Clinical Outcomes Assessments/electronic Patient Reported Outcomes (eCOA/ePRO) challenges, audit trail review, access restriction, unlocking and relocking procedures are also fundamental components of the DBL process, emphasizing the importance of risk-based activities, transparency, documentation, and data change tracking.
Keywords: Resolve Discrepancy, Query Database, Manage Accounts