Data Management Documentation and Closeout
What you must know
Documentation proves what was done and why. Core documents include the DMP, CRF and aCRF, edit check specifications, data transfer specifications, query logs, and the database lock checklist. Closeout includes database lock, final data review, archival, and transfer to the statistical team.
Concepts to master
Know the sequence: final cleaning, reconciliation, data review meeting, database lock, unblinding where applicable, and archival. Understand that lock is a formal, documented event and that post-lock changes require a documented unlock procedure. Know that records must be retained per applicable regulations and that the TMF holds essential documents.
Traps
Questions often imply that lock can occur before reconciliation is complete, or that post-lock changes are simply made without documentation. Watch for wording that treats the TMF as optional or that confuses the DMP with the statistical analysis plan.
Rule of thumb
If it is not documented, it did not happen. Before lock, confirm every query is closed, every reconciliation is signed off, and every deviation is recorded.