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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.
This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions. The discussion will be around:
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Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023
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.
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification
Japanese translation of Inv Site File Assessment V2024
Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)
Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments
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.