30Jun2025 Japanese Translation: eSRA Handbook and Assessment Forms V2025.2 30 June 2025 Read more Japanese Translation: eSRA Handbook and Assessment Forms V2025.2 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 V2025.2JP1(.pdf, 1.13 MB) - 302 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-V1(.pdf, 1.64 MB) - 617 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) - 1005 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) - 658 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 591 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 841 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 865 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 614 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 622 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 2484 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) - 816 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