Definition

The finalization of a case record in the safety database after all processing and quality review is complete, preventing further changes without formal amendment.

Example

Once an ICSR passes QC and is submitted to regulators, the case is locked. Any subsequent changes (e.g., follow-up information) require creating an amendment with documented rationale.

Regulatory source

Company SOPs, Data Integrity

Common mistakes

Locking cases before quality review is complete, or allowing locked cases to be informally modified.

Inspector question

What triggers case lock in your system? How do you handle post-lock corrections?

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