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-V1(.pdf, 1.64 MB) - 233 download(s) Read more
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) - 814 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) - 144 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) - 104 download(s) Read more
8Nov2024 Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023 08 November 2024 Read more The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to... Documents to download eCF-Requirements-PUBLIC-V2018PR(.pdf, 1.05 MB) - 504 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 429 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 570 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 547 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 476 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 461 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 1386 download(s) Read more
15Jul2024 Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 15 July 2024 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 7th 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-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 653 download(s) Read more