The "eCF Requirements" have been released to eCF Members Only. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many 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 40 different documents from FDA, EMA, PMDA, NMPA, MHRA 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. This V2024 release builds upon the V2023.3 release with additional mappings to regulatory authority documents.
If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason, the most current version of this document is always released for eClinical Forum members only eCF Members can obtain a copy by sending an email to REG@eclinicalforum.org. We also have a public release of the V2023 (last year’s eCF Requirements). This is available to non-members and can be downloaded from our website: Downloads (eclinicalforum.org).
The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org
Non-members who would like more information on becoming a member, should look at Membership (eclinicalforum.org) and/or contact Info@eclinicalforum.org