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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.
The current regulatory expectation is the investigators review and sign-off the data entered into eCRFs and other data collection tools at critical timings (including prior to interim analysis and the final analysis) in a timely manner. eClinical Forum issued a best practices document titled “Investigator’s signature on electronic Case Report Forms (eCRFs) in 2017. This team will review and align this existing document with most recent regulatory expectations on signatures collection on eCRF and eCOA data. A draft is anticipated in October 2021 and the release to the members by end of December 2021.
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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.
V2025 vs V2024 and Regulatory Basis
Comparison of V2025 to V2024 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements
Implementing eSRA - Sponsor Perspective
This guideline provides additional information to sponsors/CROs evaluating the use of eSRA forms for their organisation.
eSRA Handbook and Assessment Forms V2025
The one file you will need to complete an assessment of your e-Source or e-File systems.
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 8th 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, TFDA and ICH , and boils them down into 37 unique statements or "eCF Requirements".
eCF Spring 2025 Workshops Announced
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)