"This is the best use of my time to remain current with what is going on in the industry."
Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
We welcome feedback! Please send to: REG@eclinicalforum.org
The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites).
Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.
The eClinical Forum held an open discussion with members from pharma, CROs, and associated software vendors, to talk about this draft FDA guidance on Jan 8, 2013. The resulting comments are a consensus of member opinion. They have been submitted to the FDA on March 12, 2013.
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.
(04/11/2025 - 06/11/2025)
(04/11/2025 13:00 - 06/11/2025 15:00)
Registration for the eCF Asia Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.
The workshop will be available for in-person participation only. There will be a networking/social event in the evening. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here
Registration for the eCF Europe Autumn Hybrid Workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Medidata in London, UK, on November 4-6, 2025
The workshop will be available for both in-person participation and remote access. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 in-person seats depending on your membership type and as allocated by your eCF Primary Representative. Remote access of the live-streamed workshop is available gratis to all staff from eCF Member companies. Click to get more information on the planned topics.
Technology Showcase: eClinical Solutions: elluminate Assist – AI-driven SDTM study data analysis assistant
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area. Any eClinical Forum Member may suggest or present a Technology Showcase. READ MORE for details on this Technology Showcase.