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.

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

A complete overview of eCF Activities and plans for 2025.

Version 2024JP1 (25-Nov-2024)

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

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.

Recording available from our public webinar which provided 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. These tools are absolutely free to download as a service to the industry that we serve; we do not even collect email or other information.

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.

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.

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".

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.

Version 2024JP1 (20-May-2024)

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

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".