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The eClinical Forum provided a webinar on 18-Sep-2024 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. 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.
“eCF Requirements” - The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents (FDA, EMA, PMDA, NMPA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data. Each Requirement has, as its basis, one or more statements from one or more of these regulatory documents. The eCF Requirements can be used to determine if systems are consistent with regulatory requirements, and if systems and process that manage these data have the necessary features. This set of requirements is the result of countless hours of discussion among regulatory experts from the eClinical Forum member organizations over the past 15 years. It is updated annually.
“eSRA (Form/S)” – The eClinical Forum’s free Investigator Site self-assessment, of the readiness of their healthcare systems to originate data that could be used in a regulated clinical trial, is based on the eCF Requirements and thus each question is grounded on one or more regulatory document statements. It is easy to access and easy to use and has been used by thousands of sites around the globe and many pharmaceutical sponsors and CROs since it’s launch in 2015. It is updated annually.
“ISF System Assessment (Form/F)” – A sister assessment to eSRA, this assessment (also free to download from the eCF website), was launched in April 2024 and provides an assessment for sponsors to determine if a site’s Investigator Site File System (or “Site Trial Master System”) is appropriate for holding information for their regulated clinical trial. It is also based on eCF Requirements/regulatory authority statements. It will be updated annually.
The public version of the eCF Requirements can be downloaded at: Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) (eclinicalforum.org)
The eSRA and ISF Assessments can be downloaded at: https://eclinicalforum.org/site-sys-assmts
To review the 37-min webinar or download the slides, please see below.
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 Webinar: "Strategies for Implementing Audit Trail Review"
The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.
Registration for the eCF Americas Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Indianapolis, Indiana on October 21-23, 2025.
The workshop will be available for in-person participation only. There will be networking/social events on both evenings. 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.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14
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.
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.