The eClinical Forum REG Team has completed a significant update to the Members-Only 2023 release of the eCF Requirements for Electronic Data for Regulated Clinical Trials (commonly referred to as the “eCF Requirements”).  This updated release incorporates extensive review and mapping of the EMA Guideline for Computerised Systems and Electronic Data in Clinical Research.

The eCF Requirements are being released to eCF Members Only at this time. This living document 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 41 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH.  They have now spent countless hours over the past 6 months debating each section of this guidance and how to word the eCF Requirements to correctly meet the needs in the EMA Guideline that went into effect in Sep 2023. This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. This V2023.3 release builds upon the V2023.1 and 2 releases with additional and significant mappings and criteria text updates.

If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason this document is for eClinical Forum members only during an exclusionary period of at least 6 months.  

eCF Members (if you are reading this... then that's you!) ... can dowload a copy below.

Non-members can obtain a public release of the V2023.1 (last year’s eCF Requirements) via download from our website in the DOWNLOADS tab.