LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

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Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023
Suzanne Bishop (Americas Administrator)
/ Categories: Regulatory, Visible by MEMBERS ONLY, Report

Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023

This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over several years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from FDA, EMA, PMDA, MHRA, NMPA and ICH.  This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document.  If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly.  One of the eCF Members benefits is a full year of the most recent version of the eCF Requirements prior to it being released to the public. At this time, the public have access to "eCF Requirements PR2021" via the Download section of this website.

 The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org

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