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

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.

Documents to download

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2021
BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 
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