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.

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: 1863
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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.

ECF Steering Committee

  • 30 September 2021
  • Author: Webmaster1
  • Number of views: 3139
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ECF Steering Committee

Elected team providing strategic direction and governance.

Regulatory Advisory Group (REG)

  • 1 May 2018
  • Author: Webmaster1
  • Number of views: 4311
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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: 4693
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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.

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