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Differences between eSRA V2024 to eSRA V2023

What is the difference between the eSRA Version 2024 and eSRA Version 2023?

The eClinical Forum eSRA Team spent considerable time evaluating each eSRA question to determine updates for the 2024 version. These updates are based on the EMA guideline that went into effect in September 2023: EMA Guideline on computerised systems and electronic data in clinical trials.

What sites should complete an eSRA V2024?

  • All new sites
  • If a site with an existing completed eSRA updates their system to a new version
  • Sponsors should review differences between eSRA V2024 and eSRA V2023 to determine if they deem it significant enough to ask for existing sites to update,

We are committed to continuing to improve eSRA. Please provide feedback via email to

Documents to download


Categories: eSRANumber of views: 157