Difference between eSRA V2022 and eSRA V2021

What is the difference between the eSRA Version 2022 and eSRA Version 2021?

The eClinical Forum eSRA Team spent considerable time evaluating each eSRA question to determine updates for the 2022 version. These updates are based on:

• Updates and additions to the underlying regulatory authority documents as identified by the eClinical Forum Regulatory Advisory Group. A mapping between eSRA questions and eCF Requirements are in the document “Implementing eSRA: Sponsor Perspective”. Complete details of the eCF Requirements, including mapping to regulatory documents can be downloaded from www.eclinicalforum.org/downloads.
• A desire to make the questions more concise and clear – based on feedback from users

What sites should complete an eSRA V2021?

• All new sites
• If a site with an existing completed eSRA updates their system to a new version
• Sponsors should review differences between eSRA V2022 and eSRA V2021 to determine if they deem it significant enough to ask for existing sites to update (note: other than if a system is updated to a new version, the eSRA team does not think an updated eSRA is needed for V2022).

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