EMA eSource paper (2010) and its 1 linked instrument

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EMA eSource paper (2010)EMA CS clinical trials
AuthorityEMAEMA
Legal weightGuidance & Q&AGuidance & Q&A
StatusSupersededFinal
Last verifiedNot yetNot yet
Summary

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 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.

Lifecycle
  • 9 Jun 2010 Adopted by the GCP Inspectors Working Group
  • 1 Aug 2010 Came into effect
  • 10 Mar 2023 Replaced by the 2023 guideline
  • 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
SourceOfficial 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.