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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.
Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment)
Release 2024 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China), MHRA (UK) and ICH (International). In particular, this version incorporates updates from the EMA Guideline on computerised systems and electronic data in clinical trials (Sep 2023). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA or ISF Assessment questions should be updated.
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Japanese translation of Inv Site File Assessment
Version 2024JP1 (25-Nov-2024)
Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)
eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”
This is an eCF Birds-of-a-Feather Round-table discussion on the new landscape of AI use in clinical research document automation. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.
Webinar: eClinical Forum Membership Overview
The eClinical Forum is “For the members and by the members” and we want to be sure that we are providing our members with the best possible support for what they do. This webinar is targetted to our "primary representatives" from each eCF member organization, however anyone interested in understanding an overview of the eClinical Forum is welcome to attend. eClinical Forum membership is per company (not individual) and participation in eCF online events, project teams, and members-only publications are available to each person in a member organization without any additional cost.
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.