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) - 221 download(s) Read more
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) - 1366 download(s) eCF eSRA Handbook+Site Form Japanese translation V2025.2JP1(.pdf, 1.13 MB) - 1706 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) - 6221 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) - 1684 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 1647 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 3671 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 3391 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 1488 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 2951 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 15572 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) - 1751 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