4Apr2022 eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021 04 April 2022 Read more eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021 The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021" ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements,... Documents to download eCF Requirements PR2021 Public Release 1.0(.pdf, 1.52 MB) - 299 download(s) Read more
31Mar2022 Implementing eSRA: Sponsor Perspective 31 March 2022 Read more Implementing eSRA: Sponsor Perspective How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022) Documents to download eCF eSRA Sponsor Guide V2022(.pdf, 756 KB) - 183 download(s) Read more
30Mar2022 Difference between eSRA V2022 and eSRA V2021 30 March 2022 Read more Difference between eSRA V2022 and eSRA V2021 Documents to download Comparison of eSRA V2022 question text with eSRA V2021 question text(.pdf, 140.12 KB) - 175 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
5May2021 eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here 05 May 2021 Read more eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021 Documents to download eCF Reqs for CR Systems and eSRA Public Webinar 28-Apr-2021(.mp4, 167.92 MB) - 1102 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) - 661 download(s) Read more