25Nov2024 Japanese translation of Inv Site File Assessment 25 November 2024 Read more Japanese translation of Inv Site File Assessment Version 2024JP1 (25-Nov-2024) 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) - 107 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) - 138 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 125 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 147 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 121 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 153 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 136 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 159 download(s) Read more
1Oct2024 eCF Views & News 01 October 2024 Read more eCF Views & News We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see... Read more
18Sep2024 Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments 18 September 2024 Read more Recording available from our public webinar which provided information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF... Documents to download eCF-Free-Public-Webinar_-Regulatory-Requirements-for-Electronic-Data_Systems-for-Clinical-Trials,-and-associated-site-system-assessments-20240918_B(.mp4, 162.67 MB) - 348 download(s) eCF-Requirements-2024-Public-Webinar-Slides(.pdf, 2.15 MB) - 374 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) - 291 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