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
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