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) - 311 download(s) eCF eSRA Handbook+Site Form Japanese translation V2025.2JP1(.pdf, 1.13 MB) - 616 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) - 881 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) - 994 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 914 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 1571 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 1486 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 912 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 1024 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 5565 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) - 1118 download(s) Read more
5Jul2024 2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 05 July 2024 Read more 2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) The "eCF Requirements" Members Release V2024 has been released. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to... Read more
2Oct2023 AI state-of-play around clinical research 02 October 2023 Read more AI state-of-play around clinical research The regulatory overview presented in this paper shows that while regulations are far from final for all use cases, the US and Europe have made the biggest steps toward monitoring and facilitating the use of AI, and regulations are in development in... Documents to download AI state-of-play around clinical research_15Sep23 _vPR1_Approved by eCF for Release 28Oct23(.pdf, 1.61 MB) - 63 download(s) Read more