NEWS FROM THE ECF

Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper

Public Release PR2026.1

  • 12 February 2026
  • Author: Jana Summa
  • Number of views: 2043
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Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper

The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review". 

Since the publication of the 2021 position paper, the eClinical Forum has received requests for further guidance on implementing Audit Trail Review (ATR) strategies. ICH E6(R3) has called out the need for planned review of audit trail data. In response, this paper offers a structured and actionable framework to help organizations prioritize, operationalize, and scale their audit trail review activities. This publication marks an important advancement in how audit trail review is understood and operationalized within the context of ICH E6(R3), and focuses on three domains - Clinical Relevance, Data-Enabled Analytics, and Operational Integration.

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eCF Spring 2026 Workshops Announced!

eCF Spring 2026 Workshops Announced!

We are happy to announce our Spring workshops!

Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)

Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30

Asia: Hosted by Novartis in Tokyo, Japan on April 2-3

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eCF Spring 2026 Workshops Announced!

eCF Spring 2026 Workshops Announced!

We are happy to announce our Spring workshops!

Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)

Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30

Asia: Hosted by Novartis in Tokyo, Japan on April 2-3

Read more
30
eCF Spring 2026 Workshops Announced!

eCF Spring 2026 Workshops Announced!

We are happy to announce our Spring workshops!

Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)

Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30

Asia: Hosted by Novartis in Tokyo, Japan on April 2-3

Read more
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Release of the 2026 electronic Site Readiness Assessment (eSRA)

Release of the 2026 electronic Site Readiness Assessment (eSRA)

The latest version of eClinical Forum’s eSRA is now available for  download, free and open to the industry. If you work at a clinical research site, eSRA is designed to help you. It's a standardized checklist that lets you evaluate your readiness to support electronic clinical trial processes before a study starts, so you can identify gaps early, not mid-trial.

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Conclusion of the eCF Spring Workshops 2026

Conclusion of the eCF Spring Workshops 2026

With the conclusion of the eClinical Forum Americas Workshop last week, the Spring 2026 workshop season has officially come to a close. This year’s workshops focused strongly on the current and future use of Artificial intelligence in clinical research. Planning for the Autumn 2026 Workshops will begin soon. 

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