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) - 6355 download(s) Read more
13May2024 Assessing Investigator Site File Systems for Clinical Research 13 May 2024 Read more A brief overview of who should use the eCF's newest assessment tool ... and why. This article can be viewed or downloaded by clicking "read more". Documents to download Assessing-Clinical-Site-Investigator-File-Systems-for-Clinical-Research-Article-for-eCF-website(.pdf, 120.45 KB) - 2763 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
1Oct2019 Prominent Industry Magazines address the need for investigator site systems assessment and eSRA 01 October 2019 Read more Prominent Industry Magazines address the need for investigator site systems assessment and eSRA Documents to download Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting(.pdf, 967.43 KB) - 2284 download(s) Read more
15Jul2019 Applied Clinical Trials publishes article on eCF Requirements 15 July 2019 Read more Applied Clinical Trials publishes article on eCF Requirements Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”:... Documents to download ACT Article Keeping Up with the Regulatory Expectations July 2019(.pdf, 778.99 KB) - 3723 download(s) Read more