Database Lock & Closeout

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

Documentation describing what was included/excluded in a data cut.

A specified timestamp used to define which data are included in an interim cut.

A documented decision to accept a data issue without further resolution.

A controlled milestone when the clinical database is declared complete and changes are restricted so analysis can proceed on a stable dataset.

Restriction preventing edits to a specific form instance under defined conditions.

A structured list of criteria and sign-offs required before final lock.

A typical database lock readiness criterion: All critical queries resolved. Must be evidenced and documented before lock.

A typical database lock readiness criterion: All required e-signatures collected. Must be evidenced and documented before lock.

A typical database lock readiness criterion: Coding review completed. Must be evidenced and documented before lock.

A typical database lock readiness criterion: Data review sign-offs obtained. Must be evidenced and documented before lock.

A typical database lock readiness criterion: Final exports validated. Must be evidenced and documented before lock.

A typical database lock readiness criterion: Lock approval documented. Must be evidenced and documented before lock.

A typical database lock readiness criterion: Outstanding deviations documented. Must be evidenced and documented before lock.

A typical database lock readiness criterion: Post-lock change process defined. Must be evidenced and documented before lock.

A typical database lock readiness criterion: SAE reconciliation completed. Must be evidenced and documented before lock.

A typical database lock readiness criterion: Vendor data loaded and verified. Must be evidenced and documented before lock.

Operational period when new non-critical queries are minimized to prepare for lock.

State preventing changes without formal unfreeze; used for data cuts or closeout.

End-stage activities to finalize documentation, lock, and archive trial data.

Restriction preventing edits across a subject’s data set, often for interim reviews.

Controlled process for post-lock changes with approvals and documentation.