REFLECTION PAPER Adopted
Reflection Paper on the Use of Interactive Response Technologies in Clinical Trials
ABSTRACT — EDITORS' SUMMARY
GCP expectations for IRT systems — randomisation, drug supply management, unblinding safeguards, audit trails, and validation requirements.
EMBEDDED PDF
PDF NOT YET CACHED
This document hasn't been cached locally yet. View it directly on EMA's site.
OPEN ON EMA↗METADATA
SOURCE
PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-interactive-response-technologies-interactive-voiceweb-response-systems-clinical-trials-particular-emphasis-handling-expiry-dates_en.pdf ↗ RELATED · SAME AUTHORITY