How should late data changes be handled after database lock?

Why

Imagine a clinically important death date is corrected after the analysis dataset was locked. Determine whether the correction affects an endpoint, safety reporting, analysis population or submission. Record the discrepancy, source evidence, rationale, change request, approvers and affected datasets.

If an unlock is warranted, restrict changes to authorized personnel and maintain the identity and time of original and revised values. Regenerate impacted SDTM, ADaM and analysis outputs as applicable, re-run validation and reconcile deliverables, then relock through documented approval. In some workflows a post-lock note may suffice for issues without analysis impact, but this must follow approved procedures rather than individual convenience.

Keep versioned snapshots so both the original submission state and the corrected state can be reconstructed.