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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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Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

の日本語版2025.2JP1が2025年6月30日にリリースされました。

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eCF Views & News

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.

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eCF "BoF" Round table: "A Chat about eCOA"

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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. 

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