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V2025 vs V2024 and Regulatory Basis

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

eCF eSRA Release 2025 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China), MHRA (UK) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA forms questions should be updated.

This document provides an easy look at the differences between the 2 eSRA Forms (Form/S for eSource and Form/F for eFile systems) as well as a comparison to the previous versions of each as well as a mapping to the underlying regulatory statements that support each eSRA question.

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Technology Showcase: eClinical Solutions: elluminate Assist – AI-driven SDTM study data analysis assistant

This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area.  Any eClinical Forum Member may suggest or present a Technology Showcase. READ MORE for details on this Technology Showcase.

 

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Getting the most out of your eCF Membership 2026

Getting the most out of your eCF Membership 2026

Here is an overview of the eClinical Forum activities and benefits. A quick read to pass around to your colleagues! We want all our members to get the most out of their membership ... to be sure that all of their staff know what is available to them as part of their organisation's membership. We also want prospective new-comers to see what we have been up to and what is coming!

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