DATA BASE LOCK
PROCESSES AND
TIMELINES
WHAT IS DATABASE LOCK?
• Database lock (DBL) is a significant milestone in a clinical trial, upon which further
data analysis and reporting timelines depend.
• It is an action that involves “locking” data to prevent unauthorized or unintentional
data changes after all project maintenance tasks have been completed.
• Database lock is the most important step before data extraction, which is in turn
followed by data archival.
• The Clinical Data Manager is responsible for steering the data management process
to ensure that the database is locked correctly and on time.
IMPORTANCE OF DATABASE LOCK
• Database lock is performed to maintain data quality, integrity,
and reliability for the generation of results, analyses and
submissions
• For randomized or blinded studies, database closure is even
more critical to ensure blinding is not broken prematurely or by
unauthorized personnel and to preserve data integrity after
breaking the blind.
DATABASE LOCK(DBL) STEPS
1 2 3 4
Plan for Finalize Obtain PI Hard-lock of
Database data Signatures CRFs
Lock
PLANNING FOR DATABASE LOCK
• The CDM drafts the database closeout timelines and distributes to the Study
Management Team (SMT) for review at least one week prior to the Study Closeout
Kick-Off Meeting.
• The timeline must include specific tasks and deadlines which are addressed to
each stakeholder
• During the Kick-off meeting, SMT provides comments on the timeline draft before
it is finalized
• CDM must oversee cross-functional activities and manage the timelines
throughout the study database closeout process.
Database
Closure
Checklist
FINALIZING DATA
• Confirm that all data entry is complete. Study Drug
Completion/Discontinuation eCRFs must be completed
• Confirm that all reconciliation processes have been completed (SAE, Third-
party reconciliation)
• Ensure all Protocol Deviations have been recorded
• Review the coding report for consistency and completeness
• Ensure the SDTM report has been run and data is in the expected format
• Soft lock/data freeze
FINALIZING DATA CONT’D
• Engage the Statistics Team, Medical Team and Safety Team
• Engage sites
• Inactivation of log lines, forms or folders completed in error or
CRFs that will not be used due to early discontinuation
• DMP Finalization
• Review of study reports (Listings, Missing pages report, Page
Status)
OBTAINING PI SIGNATURES
• Confirm all Principal Investigators (PIs) have access to their
accounts and eLearning training has been completed.
• Ensure PIs review all CRFs to confirm accuracy and consistency
• Ensure PIs approve all casebooks after all data review is
complete
• Download and save a copy of the PI signature report
HARD-LOCK OF CRFs
• Once the approval for locking is obtained from all stakeholders,
the database is locked
• All CRFs are hard-locked. This process is done manually by the
CDM.
• Sign the SDM EDC Study Closeout Checklist and Database lock
form
POST-DBL ACTIVITIES
Removal of Distribution of Data Data archival Data Review of CSR
site access site data Clarification extraction for
log analysis
THANKS FOR LISTENING
