NEWS FROM THE ECF

eCF Views & News

July 2025

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.

Japanese Translation: eSRA Handbook and Assessment Forms V2025

Japanese Translation: eSRA Handbook and Assessment Forms V2025

の日本語版2025.2JP1が2025年6月30日にリリースされました。

eCF Views & News

June 2025

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 Views & News

May 2025

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.

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

Public Release PR2024

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 8th 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, TFDA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

eCF Views & News

April 2025

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.

Getting the most out of your eClinical Forum membership 2025

January 9, 2025 webinar slides

Getting the most out of your eClinical Forum membership 2025

A complete overview of eCF Activities and plans for 2025.

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

Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

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.

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".

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eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data

Log in to your eCF website account to see more:

RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities? 

The webinar is available to all our members. Date and Time: Wednesday, 25 February 2026, 14:00 UTC.

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eCF Public Webinar March: Turning the ATRA Position Paper into Practice

Log in to your eCF website account to see more:

This webinar focuses on practical implementations of the eCF industry position paper "Strategies for implementing Audit Trail Review"

The webinar is available to all our members as well as the general public. Date and Time: Thursday, 19 March 2026, 9:00 am EDT / 1:00 pm UTC. Sign up here

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