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

Everything accounted for

Confirms every plan and report referenced throughout the study — from the DMP to DM reports — is complete and filed.

The paper trail behind the lock

Supports inspection readiness by giving auditors one complete, organized record.