V2026 vs V2025 and Regulatory Basis

Comparison of V2026 to V2025.3 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.