WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

Digital Health Technologies Governance

Digital Health Technologies Governance

This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators.  Address the problem of generic regulations and create industry guidelines more tangible and actionable.

Audit Trail Review Analytics (ATRA)

Audit Trail Review Analytics (ATRA)

Team started in August 2024.  The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor companies and technology vendors.

Essential Metadata

Essential Metadata

The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.

Artificial Intelligence and Machine Learning

  • 2 November 2022
  • Author: Webmaster1
  • Number of views: 850
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Artificial Intelligence and Machine Learning

The joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.

Decentralised Clinical Trials

  • 2 November 2022
  • Author: Webmaster1
  • Number of views: 746
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Decentralised Clinical Trials

The DCT Working Group is a joint effort between eClinical Forum and EUCROF. The team's objectives are to define DCT terms and to develop position papers and roadmaps on DCT solutions that simplify patient and site experiences. 

Investigator Site File (ISF Assessment)

Investigator Site File (ISF Assessment)

Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.

Regulatory Advisory Group (REG)

  • 1 May 2018
  • Author: Webmaster1
  • Number of views: 3130
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Regulatory Advisory Group (REG)

The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites).

eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

  • 1 March 2018
  • Author: Webmaster1
  • Number of views: 3416
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eSRA Maintenance

Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.

ECF Steering Committee

  • 1 January 2006
  • Author: Webmaster1
  • Number of views: 2106
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ECF Steering Committee

Elected team providing strategic direction and governance

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Japanese translation of Inv Site File Assessment

Japanese translation of Inv Site File Assessment

Version 2024JP1 (25-Nov-2024)

Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)

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eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”

eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”

This is an eCF Birds-of-a-Feather Round-table discussion on the new landscape of AI use in clinical research document automation.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.

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