INSPECTION PROCEDURE 2022 revision
Annex IV — Sponsor and Contract Research Organisations (CRO)
ABSTRACT — EDITORS' SUMMARY
Items verified at sponsor and CRO sites during EMA-coordinated GCP inspections. The operational checklist underneath Annex IV of the EMA inspection procedure.
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PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iv-procedure-conducting-gcp-inspections-requested-chmp-sponsor-and-contract-research-organisations-cro_en.pdf ↗ RELATED · SAME AUTHORITY