Definition

A formal, documented change to a previously finalized case record, with clear rationale and audit trail.

Example

After case lock, medical review identifies an incorrect seriousness assessment. An amendment is created documenting the error, correction, rationale, and reviewer approval.

Regulatory source

Data Integrity Guidelines, Company SOPs

Common mistakes

Making amendments without proper documentation or approval, which compromises data integrity.

Inspector question

Walk me through your amendment process. Who has authority to approve amendments?

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