30Jun2025 Japanese Translation: eSRA Handbook and Assessment Forms V2025 30 June 2025 Read more Japanese Translation: eSRA Handbook and Assessment Forms V2025 の日本語版2025.2JP1が2025年6月30日にリリースされました。 Documents to download eCF eSRA Handbook+Site Form Japanese translation V2025.3JP1(.pdf, 1.12 MB) - 64 download(s) eCF eSRA Handbook+Site Form Japanese translation V2025.2JP1(.pdf, 1.13 MB) - 396 download(s) Read more
25Apr2025 eSRA Handbook and Assessment Forms V2025.3 25 April 2025 Read more eSRA Handbook and Assessment Forms V2025.3 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 V2025.3(.pdf, 1.72 MB) - 460 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 V2025.1(.pdf, 737.94 KB) - 70 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) - 399 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) - 284 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) - 959 download(s) eCF-Requirements-2024-Public-Webinar-Slides(.pdf, 2.15 MB) - 962 download(s) Read more