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) - 25 download(s) Read more
2Oct2023 White Paper Released by the Artificial Intelligence and Machine Learning Working Group 02 October 2023 Read more White Paper Released by the Artificial Intelligence and Machine Learning Working Group The Artificial Intelligence and Machine Learning Team is pleased to announce the public release of theirwhite paper titled "AI state-of-play around clinical research" The white paper were written by a joint task force from the eClinical... Documents to download AI state-of-play around clinical research_15Sep23 _vPR1_Approved by eCF for Release 28Oct23(.pdf, 1.61 MB) - 266 download(s) 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) - 986 download(s) Decommissioning White Paper version PR1(.pdf, 454.21 KB) - 1090 download(s) Nature of a Distributed TMF - Practical Aspects PR1(.pdf, 467.86 KB) - 960 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) - 2114 download(s) Read more
4Apr2022 Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023 04 April 2022 Read more Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023 ABOUT THE ECF REQUIREMENTSThe eClinical Forum has updated their set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support... Documents to download eCF Requirements MR2023 Members Release V2(.pdf, 1.42 MB) - 259 download(s) Read more
2Dec2021 Submission of comments on EMA’s draft “Guideline on computerised systems and electronic data in clinical trials” 02 December 2021 Read more These comments are provided by a team with representatives from 13 eCF member companies and have been reviewed by the eClinical Forum members. Those on the team are from Sweden, UK, Switzerland, Belgium, Spain, Germany, Italy, United States, and... Documents to download eCF Comments EMA draft guidance Computerised Systems FINAL(.pdf, 505.85 KB) - 498 download(s) Read more