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. 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. Read more
21Apr2025 V2025 vs V2024 and Regulatory Basis 21 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(.pdf, 292.62 KB) - 18 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) - 627 download(s) eCF-Requirements-2024-Public-Webinar-Slides(.pdf, 2.15 MB) - 670 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) - 577 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) - 1313 download(s) Read more