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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.
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.
The eCF Requirements are being released to eCF Members Only at this time. This living document is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over several years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from 41 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH. They have now spent countless hours over the past 6 months debating each section of this guidance and how to word the eCF Requirements to correctly meet the needs in the EMA Guideline that went into effect in Sep 2023. This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. This V2023.3 release builds upon the V2023.1 and 2 releases with additional and significant mappings and criteria text updates.
If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason this document is for eClinical Forum members only during an exclusionary period of at least 6 months.
eCF Members (if you are reading this... then that's you!) ... can dowload a copy below.
Non-members can obtain a public release of the V2023.1 (last year’s eCF Requirements) via download from our website in the DOWNLOADS tab.
NOT A MEMBER?
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.
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.
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.
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".
eCF Birds-of-a-Feather Webinar: Protocol Optimization using AI/ML
We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.
eCF Technology Showcase Webinar: OpenClinca “Unlocking Clinical Data from EHRs”
What if site users could launch the eCRF with a single click from the patient’s chart, and automatically populate CRFs with data from the chart? This is a Technology Showcase hosted by our newest eCF member, OpenClinica.
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.
eCF Americas Autumn Workshop 2024 Announced
Registration is open! Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.