Unauthorized Data Changes Cited in Clinical Data Audit Reports
Unauthorized Data Changes Cited in Clinical Data Audit Reports Unauthorized Data Changes as a Recurring Clinical Audit Finding Introduction: Why Unauthorized Data Changes Compromise Data Integrity Clinical trial data must be reliable, verifiable, and fully traceable. Unauthorized changes to trial data—whether intentional or due to weak system controls—represent a breach of the ALCOA+ principles (Attributable,…
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