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Differences between eSRA V2024 to eSRA V2023

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 eSRA@eclinicalforum.org.

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

Presenter:        Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic:  The final piece of the GCP renovation puzzle, revision 3 of ICH GCP.  Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.

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eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

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eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.

The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.

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