Everything accounted for
Confirms every plan and report referenced throughout the study, from the DMP to DM reports, is complete and filed.
What's included
What goes into the lock package
- Final review confirming the database matches the approved data management plan and edit check specifications
- All plans, logs, and DM reports referenced throughout conduct verified complete and filed
- Outstanding documentation gaps identified and closed before sign-off
- Records reconciled into a single, organized lock package rather than left scattered across the study file
- Final package structured to support inspection readiness requirements
The paper trail behind the lock
Supports inspection readiness by giving auditors one complete, organized record.
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