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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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«September 2026»
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eCF Webinar September "ICH E6 (R3) Annex 2"

Join us for a discussion on CH E6 (R3) Annex 2 and its role in modernizing GCP to better reflect the evolving landscape of clinical research on Wednesday, September 9, 2026.

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