4May2026 Implementing eSRA: Sponsor Guide 2026 04 May 2026 Read more Implementing eSRA: Sponsor Guide 2026 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 V2026(.pdf, 408.55 KB) - 33 download(s) Read more
4May2026 V2026 vs V2025 and Regulatory Basis 04 May 2026 Read more V2026 vs V2025 and Regulatory Basis Comparison of V2026 to V2025 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements Documents to download Comparison of eSRA V2026 with V2025 and regulatory basis(.pdf, 204.19 KB) - 26 download(s) Read more
4May2026 eSRA Handbook and Assessment Forms V2026 04 May 2026 Read more eSRA Handbook and Assessment Forms V2026 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 2026 VERSION(.pdf, 1.24 MB) - 533 download(s) Read more
12Feb2026 Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper 12 February 2026 Read more Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review". Documents to download eCF ATRA Industry Position Paper_PR2026.1(.pdf, 2.38 MB) - 1358 download(s) Read more
27Apr2025 Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 27 April 2025 Read more Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) The eClinical Forum is releasing its 8th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA,... Documents to download eCF Requirements PR2024 Public Release V2(.pdf, 2.19 MB) - 9081 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) - 7291 download(s) Read more