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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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«March 2026»
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eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data

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RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities? 

The webinar is available to all our members. Date and Time: Wednesday, 25 February 2026, 14:00 UTC.

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eCF Public Webinar March: Turning the ATRA Position Paper into Practice

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This webinar focuses on practical implementations of the eCF industry position paper "Strategies for implementing Audit Trail Review"

The webinar is available to all our members as well as the general public. Date and Time: Thursday, 19 March 2026, 9:00 am EDT / 1:00 pm UTC. Sign up here

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