WHO WE ARE

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

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" have been released to eCF Members Only. 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 evaluating 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.  This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document. This V2024 release builds upon the V2023.3 release with additional mappings to regulatory authority documents.

If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason, the most current version of this document is always released for eClinical Forum members only eCF Members can obtain a copy by sending an email to REG@eclinicalforum.org.   We also have a public release of the V2023 (last year’s eCF Requirements). This is available to non-members and can be downloaded from our website: Downloads (eclinicalforum.org).  

The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org

Non-members who would like more information on becoming a member, should look at Membership (eclinicalforum.org) and/or contact Info@eclinicalforum.org 

Print
Tags:
Rate this article:
No rating

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«July 2024»
MonTueWedThuFriSatSun
242526
eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

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.

Read more
27282930
12
eCF Views & News

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.

Read more
345
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

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.

Read more
67
891011121314
15
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

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".

Read more
161718
eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

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.

Read more
192021
22232425262728
2930311234

Upcoming events Events RSSiCalendar export