EMA CS clinical trials and its 2 linked instruments

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	EMA CS clinical trials	EMA eSource paper (2010)	EMA notice: CS in trials
Authority	EMA	EMA	EMA
Legal weight	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A
Status	Final	Superseded	Final
Last verified	Not yet	Not yet	Not yet
Summary	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.	Earlier EMA reflection paper on electronic source data in clinical trials. EMA has replaced it with the Guideline on computerised systems and electronic data in clinical trials.	EMA notice to clinical trial sponsors on validating and qualifying computerised systems, such as electronic case report forms and patient reported outcome tools.
Lifecycle	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	9 Jun 2010 Adopted by the GCP Inspectors Working Group 1 Aug 2010 Came into effect 10 Mar 2023 Replaced by the 2023 guideline	7 Apr 2020 First published 29 Oct 2026 Revision 1: administrative update of references
Source	Official text Source: EMA.	Official text Source: EMA.	Official text Source: EMA.

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.