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(.pdf, 1.89 MB) - 480 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) - 93 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) - 50 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) - 666 download(s) eCF-Requirements-2024-Public-Webinar-Slides(.pdf, 2.15 MB) - 699 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) - 659 download(s) Read more
20May2024 Japanese translation of eSRA V2024 20 May 2024 Read more Japanese translation of eSRA V2024 Version 2024JP1: Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳) Documents to download Handbook+Site-Form-V2024JP1(.pdf, 1010.78 KB) - 1363 download(s) Read more