EMA notice: CS in trials and its 2 linked instruments

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	EMA notice: CS in trials	EMA CS clinical trials	ICH E6(R3) GCP
Authority	EMA	EMA	ICH
Legal weight	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A
Status	Final	Final	Final
Last verified	Not yet	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.	EMA guideline for clinical trials on computerised systems and electronic data. It covers data integrity, responsibilities, validation, audit trails, user management, security, data migration and archiving, and it includes artificial intelligence. It replaced the 2010 reflection paper on electronic source data.	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	18 Jun 2021 Public consultation started 17 Dec 2021 Public consultation closed 7 Mar 2023 Final version adopted by the GCP Inspectors Working Group 10 Mar 2023 Final version published	8 Sep 2025 Published by FDA as final guidance
Source	Official text Source: EMA.	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.