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) - 111 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) - 2148 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 Documents to download eCF Comments EMA draft guidance Computerised Systems FINAL(.pdf, 505.85 KB) - 521 download(s) Read more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) - 1636 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) - 1102 download(s) Read more