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 – on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA... Documents to download eCF Reqs for CR Systems and eSRA Public Webinar 28-Apr-2021(.mp4, 167.92 MB) - 894 download(s) Read more
15Mar2021 Implementing eSRA: Sponsor Perspective 15 March 2021 Read more Implementing eSRA: Sponsor Perspective How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2021) Documents to download eCF eSRA Sponsor Guide V2021(.pdf, 785.71 KB) - 957 download(s) Read more
10Mar2021 eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020 10 March 2021 Read more eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020 The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020" ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements,... Documents to download eCF Requirements PR2020 Public Release V1.1(.pdf, 772.47 KB) - 1031 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) - 568 download(s) Read more