INSPECTION PROCEDURE 2022 revision

Annex IV — Sponsor and Contract Research Organisations (CRO)

EMA/INS/GCP/155794/2022 European Medicines Agency

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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METADATA

TypeINSPECTION PROCEDURE

Year2022

Version2022 revision

StatusCurrent

FormatPDF

Pages—

Size293 KB

Last reviewedMAY 2022

SOURCE

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 ↗

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