18Sep2024 Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments 18 September 2024 Read more Recording available from our public webinar which provided information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF... Documents to download eCF-Free-Public-Webinar_-Regulatory-Requirements-for-Electronic-Data_Systems-for-Clinical-Trials,-and-associated-site-system-assessments-20240918_B(.mp4, 162.67 MB) - 573 download(s) eCF-Requirements-2024-Public-Webinar-Slides(.pdf, 2.15 MB) - 619 download(s) Read more
26Aug2021 eSRA was used in a Japanese research paper on data quality of medical information systems 26 August 2021 Read more eSRA was used in a Japanese research paper on data quality of medical information systems Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems." 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