eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

24 March 2024 Public Release

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023.1"

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

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, 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.  If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly.

This release, PR2023.1 is for Public Use

The 2023.1 Version document is being released to the public as we believe that it will be of significant use to all.  

At this time, the most current version (2023.3) of the eCF Requirements is reserved for eClinical Forum members only.  This was released in Nov 2023 and incorporates requirements from the EMA Guideline on computerised systems and data in clinical trials (effective date 7 September 2023). 

For information on becoming an eClinical Forum member (and thus having access to the eCF Requirements V2023.3, which has significant updates), please see membership details at www.eclinicalforum.org/membership or send us a note at info@eclinicalforum.org and we will be happy to set up a phone meeting to discuss all the benefits that come to an organization through membership. Please note – membership is by organization only; there are no individual membership options.

The eCF has also produced a questionnaire, based on the eCF Requirements, that can be used for sites to assess if their EHR/EMR systems are suitable for originating data that could be used in a regulated clinical trial. This free tool is called “eSRA” for “eSource-Readiness Assessment” and can be downloaded from the eClinical Forum website in the eSRA tab.  

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