Compare EMA CS clinical trials and EMA eSource paper (2010)

How to read this page

How they are linked says why these two documents are connected. Links explained
Side by side places facts from each record together, so you can see status, weight and dates at a glance.
It does not compare content. It does not say which is stricter. Read the official texts for that.

Details: Guide Definitions: every term and label explained

How they are linked

EMA CS clinical trials replaces EMA eSource paper (2010) · Source Unverified link

Side by side

	EMA CS clinical trials	EMA eSource paper (2010)
Authority	EMA	EMA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Superseded
Last verified	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.
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
Source	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.