9Jan2025 Getting the most out of your eClinical Forum membership 2025 09 January 2025 Read more Getting the most out of your eClinical Forum membership 2025 A complete overview of eCF Activities and plans for 2025. Documents to download Getting-the-most-out-of-your-eCF-Membership-Jan-2025(.pdf, 7.99 MB) - 162 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) - 304 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 248 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 288 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 272 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 301 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 270 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 399 download(s) 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) - 489 download(s) eCF-Requirements-2024-Public-Webinar-Slides(.pdf, 2.15 MB) - 541 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) - 447 download(s) Read more
24Mar2024 eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023 24 March 2024 Read more eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023 The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023" ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements,... Documents to download eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 1002 download(s) Read more
17Jun2021 "When should audit trail begin?" 17 June 2021 Read more "When should audit trail begin?" Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails... Read more