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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

White Paper Released by the Artificial Intelligence and Machine Learning Working Group

Better Together

  • 2 October 2023
  • Author: Webmaster1
  • Number of views: 305
  • 0 Comments
White Paper Released by the Artificial Intelligence and Machine Learning Working Group

The Artificial Intelligence and Machine Learning Team is pleased to announce the public release of theirwhite paper titled "AI state-of-play around clinical research"

The white paper were written by a joint task force from the eClinical Forum and Eucrof.

Japanese translation of eSRA V2023

Japanese translation of eSRA V2023

Version 2023.2JP1 (18-Sep-2023)

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

 

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

The Archiving and Decommission Team is pleased to announce the public release of three white papers:

  • "The Decommissioning of Computerised Systems Used in Clinical Trials" 
  • "Nature of a Distributed Trial Master File ‐ Practical Aspects"
  • "Data Formats Used in Clinical Trials"

These white papers were written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

Artificial Intelligence and Machine Learning

  • 2 November 2022
  • Author: Webmaster1
  • Number of views: 569
  • 0 Comments
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: 467
  • 0 Comments
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.

Best Practice Document on Investigator’s Signature

Best Practice Document on Investigator’s Signature

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1"

About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor.  eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor. 

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

eSRA was used in a Japanese research paper on data quality of medical information systems

Japan Society for Medical Informatics

eSRA was used in a Japanese research paper on data quality of medical information systems

Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

"When should audit trail begin?"

Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?"  It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

We welcome feedback! Please send to: REG@eclinicalforum.org 

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eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

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eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

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eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

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13/05/2024

Assessing Investigator Site File Systems for Clinical Research

A brief overview of who should use the eCF's newest assessment tool ... and why. This article can be viewed or downloaded by clicking "read more".

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Japanese translation of eSRA V2024

Japanese translation of eSRA V2024

Version 2024JP1 (20-May-2024)

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

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