Compare EMA notice: CS in trials and ICH E6(R3) GCP

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EMA notice: CS in trials is related to ICH E6(R3) GCP · Source Unverified link

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	EMA notice: CS in trials	ICH E6(R3) GCP
Authority	EMA	ICH
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
Last verified	Not yet	Not yet
Summary	EMA notice to clinical trial sponsors on validating and qualifying computerised systems, such as electronic case report forms and patient reported outcome tools.	Revised ICH guideline on good clinical practice. FDA says it adds flexible, risk-based approaches and embraces innovations in trial design, conduct and technology.
Lifecycle	7 Apr 2020 First published 29 Oct 2026 Revision 1: administrative update of references	8 Sep 2025 Published by FDA as final guidance
Source	Official text Source: EMA.	Official text Source: ICH.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.