25Apr2025 eSRA Handbook and Assessment Forms V2025 25 April 2025 Read more eSRA Handbook and Assessment Forms V2025 The one file you will need to complete an assessment of your e-Source or e-File systems. Documents to download eCF eSRA Handbook and Forms V2025.2(.pdf, 1.38 MB) - 442 download(s) Read more
24Apr2025 Implementing eSRA - Sponsor Perspective 24 April 2025 Read more Implementing eSRA - Sponsor Perspective This guideline provides additional information to sponsors/CROs evaluating the use of eSRA forms for their organisation. Documents to download eCF-eSRA-Site-System-Sponsor-Guide-V2025(.pdf, 644.89 KB) - 294 download(s) Read more
23Apr2025 V2025 vs V2024 and Regulatory Basis 23 April 2025 Read more 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 Documents to download Comparison-of-eSRA-V2025-with-V2024-and-regulatory-basis-v2(.pdf, 293.76 KB) - 249 download(s) Read more
9Apr2025 Questions from eSRA Users 09 April 2025 Read more Questions from eSRA Users This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team. Documents to download Questions posed to eSRA Admin V2025(.pdf, 178.09 KB) - 90 download(s) Read more
26Nov2024 Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments 26 November 2024 Read more Documents to download eCF-Free-Public-Webinar_-Regulatory-Requirements-for-Electronic-Data_Systems-for-Clinical-Trials,-and-associated-site-system-assessments-20240918_B(.mp4, 162.67 MB) - 831 download(s) eCF-Requirements-2024-Public-Webinar-Slides(.pdf, 2.15 MB) - 830 download(s) Read more
25Nov2024 Japanese translation of Inv Site File Assessment V2024 25 November 2024 Read more Japanese translation of Inv Site File Assessment V2024 Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳) Documents to download Japanese-translation-eCF-ISF-Assessment-Handbook-V2024-JP1(.pdf, 899.5 KB) - 872 download(s) Read more