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) - 112 download(s) Read more
19Dec2023 Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes 19 December 2023 Read more Congratulations to the joint C-Path/eCF :eCOA Best Practices" Team for publishing their paper “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes” in the peer-reviewed SCDM Journal... Read more
12Apr2023 Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team 12 April 2023 Read more Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team The Archiving and Decommission Team is pleased to announce the public release of three white papers: "The Decommissioning of Computerised Systems Used in Clinical Trials" "Nature of a Distributed Trial Master File ‐... Documents to download Formats White Paper PR1(.pdf, 472.09 KB) - 1062 download(s) Decommissioning White Paper version PR1(.pdf, 454.21 KB) - 1147 download(s) Nature of a Distributed TMF - Practical Aspects PR1(.pdf, 467.86 KB) - 1017 download(s) Read more
1Jul2022 Public Release: English Translation of V2.00 of Japan EDC Management Sheet 01 July 2022 Read more Public Release: English Translation of V2.00 of Japan EDC Management Sheet The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00. EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA)... Documents to download PMDA EDC Management Sheet v2.0 – Unverified eCF English translation EN2.02(.xlsx, 64.9 KB) - 2150 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. Even in 2024, the content is still relevant. Documents to download eCF Reqs for CR Systems and eSRA Public Webinar 28-Apr-2021(.mp4, 167.92 MB) - 1638 download(s) Read more