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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

EU Hybrid Workshop Announced

Oct 15-17 2024

  • 15/10/2024 - 17/10/2024
  • Author: Adam Perkins
  • Number of views: 139
  • 0 Comments
EU Hybrid Workshop Announced

Registration is open! Our EU Hybrid Workshop will be kindly hosted by Boehringer Ingelheim at their offices in Ingelheim am Rhein, Germany on October 15-17 2024.

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

Sept 18, 2024

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.

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public Release PR2023.3

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Members Release MR2024

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The "eCF Requirements" Members Release V2024 has been released.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for  electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.

eCF Views & News

August 2024

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

Assessing Investigator Site File Systems for Clinical Research

By Pablo Perez, Lead Quality Assurance Data Integrity, Astellas

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".

New eCF ISF System Assessment!

New eCF ISF System Assessment!

eClinical Forum now has 2 FREE assessment forms for sites to self-assess their systems for use in regulated clinical trials. We are excited to release the first version of the “ISF System Assessment”.   This assessment form is very similar to our eSource-Readiness Assessment (eSRA) and is, like eSRA, based on regulatory documents from regulators around the globe.

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

24 March 2024 Public Release

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

eClinical Forum has released the 2024 version of their “eSource Readiness Assessment” – eSRA

It is a response to the growing expectation by regulatory agencies for clinical trial sponsors to verify that clinical research site systems (e.g., EHRs) comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. V2024 includes updates based on the EMA Guideline on computerised systems and electronic data in clinical trials.

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”. 

eCF REG Team has updated the "eCF Requirements" to include mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

Members Release MR2023.3

eCF REG Team has updated the "eCF Requirements" to include mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

The eClinical Forum REG Team has completed a significant update to the Members-Only 2023 release of the eCF Requirements for Electronic Data for Regulated Clinical Trials (commonly referred to as the “eCF Requirements”).  This updated release incorporates extensive review and mapping of the EMA Guideline for Computerised Systems and Electronic Data in Clinical Research. This document is invaluable in determining if electronic records and systems are appropriate for use in regulated clinical trials.

eCF APAC Workshop -- All's well that ends well

  • 18 November 2023
  • Author: Kenichi Nakano
  • Number of views: 239
  • 0 Comments
eCF APAC Workshop -- All's well that ends well

eClinical Forum's two-day APAC Workshop was held in Kobe on 13 & 14-Nov-2023. The workshop was such a great success, thanks to generous and attentive hosting by Eli Lilly and thanks to all the participants from sponsors, investigator sites and system integrators who made contributions through thought-provoking presentations, intelligent comments/questions and friendly discussions. Thank you all and see you at next year's workshop!

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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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