Retention Requirements for Deviation Documentation
Protocol deviations are critical records in clinical trials, providing evidence of trial conduct, subject protection, and regulatory compliance. Retaining deviation documentation is not optional—it is a core expectation under ICH-GCP, FDA, EMA, and other regional guidelines. These records help stakeholders assess trial integrity during audits, inspections, and regulatory submissions. Additionally, deviation documentation supports ongoing quality assurance, RCA reviews, and CAPA effectiveness assessments.
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