Guided Notes

Study Close-Out & Archiving

After lock: data archives and formats, site data return (PDFs of eCRFs), record retention, decommissioning systems, lessons learned and TMF completeness.

What happens after the analysis

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• Final datasets and documentation archived. • Sites receive copies of their eCRF data (typically PDF archives) — required so investigators keep records of their subjects' data. • EDC access for sites ends after they confirm receipt. • Systems decommissioned per vendor contract after archiving. • TMF completeness check and final filing.