"This is the best use of my time to remain current with what is going on in the industry."
Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)
The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.
This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators. Address the problem of generic regulations and create industry guidelines more tangible and actionable.
Team started in August 2024. The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor companies and technology vendors.
The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.
The Archiving and Decommission Team is pleased to announce the public release of three white papers:
These white papers were written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.
The joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.
The DCT Working Group is a joint effort between eClinical Forum and EUCROF. The team's objectives are to define DCT terms and to develop position papers and roadmaps on DCT solutions that simplify patient and site experiences. Read more
Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.
The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback. With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool. This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.
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).
The eCF is releasing 3 documents via the eCF website “Members” area (un/pw required). Please feel free to download them and share with other members of your company.
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.
Birds-of-a-Feather Round-table on eCOA Topics
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )
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