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

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

New eCF Project

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.

Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Publication from joint team of C-Path and eClinical Forum

Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Congratulations to the joint C-Path/eCF :eCOA Best Practices" Team for publishing their paper “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes”

 in the peer-reviewed SCDM Journal “Digital First”. 

Artificial Intelligence and Machine Learning

  • 2 November 2022
  • Author: Webmaster1
  • Number of views: 719
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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: 629
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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.

Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 3267
  • 0 Comments
Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

Regulatory Advisory Group (REG)

  • 1 May 2018
  • Author: Webmaster1
  • Number of views: 2973
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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: 3255
  • 0 Comments
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.

Regulatory Expert Group (REG)

Maintaining group expertise in regulatory environment

  • 5 May 2015
  • Author: Webmaster1
  • Number of views: 2774
  • 0 Comments
Regulatory Expert Group (REG)

Maintaining ECF expertise in the regulatory environment and trends

ECF Steering Committee

  • 1 January 2006
  • Author: Webmaster1
  • Number of views: 2031
  • 0 Comments
ECF Steering Committee

Elected team providing strategic direction and governance

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eCF Free Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments

eCF Free Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments

The eClinical Forum is pleased to offer a free public webinar – to provide information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. 18-Sept-24: Registration Required.

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