LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.


ECF Teams and Projects

eCF Views & News 05 June 20240

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.

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials 26/06/20240

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

13 May 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".

New eCF ISF System Assessment! 08 April 20240

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 20240

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.

03 February 2024

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.

19 December 2023

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 24 November 20230

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 20230

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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