"This is the best use of my time to remain current with what is going on in the industry."
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.
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.
eClinical Forum Birds-of-a-Feather round-table webinars focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
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".
A complete overview of eCF Activities and plans for 2025.
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 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".
NOT A MEMBER?
eCF Views & News
eCF “Birds of a Feather” Webinar: Patient Voices: Transforming Healthcare Innovation
We will have a discussion with Savvy Cooperative on how engaging patient experiences can lead to better clinical, regulatory, and commercial outcomes.
eCF "BoF" Round table: "A Chat about eCOA"