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Disclaimer:The information presented in these works draws upon the combined understanding and knowledge of the eClinical Forum and is provided as an aid to understanding the environment for electronic clinical research. The opinions of the author(s) and the eClinical Forum do not necessarily reflect the position of individual companies.The content is unconfirmed and users should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.

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What is the difference between the eSRA 2020 and eSRA 2021?

What is the difference between the eSRA Version 2021 and eSRA Version 2020?

The eClinical Forum eSRA Team spent considerable time evaluating each eSRA question to determine updates for the 2021 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
  • Reduction of redundancy by combining some questions

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 V2020 and eSRA V2021 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 eSRA@eclinicalforum.org.

Please download to see the comparison of each eSRA question to the previous year's eSRA question.

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