eClinical Forum - New version of eCF Requirements and Webinar

19th July 2024

News from the eClinical Forum:

The eClinical Forum (eCF) is a global not‐for‐profit and non‐commercial, technology independent group representing members of the pharmaceutical, biotechnology, and allied industries. The eClinical Forum’s mission is to serve these industries by focusing on those systems, processes and roles relevant to electronic capture, management and submission of clinical data in order to promote and improve the use of electronic data in all areas of clinical research.    We are providing this information free of charge and free of advertising.

What expectations do FDA, EMA, PMDA, MNPA, MHRA and ICH put on your e-clinical systems … and how can you easily keep an eye on them as they change?   Happily for you – the eClinical Forum is releasing its 7^th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from these regulatory authorities, and boils them down into 37 statements for you to follow. Each eCF Requirement is “held up” by a series of mappings to the regulatory authority documents. The eCF Requirements can be used to determine if systems that handle 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.

The eClinical Forum is releasing this version (V2023.3PR) as a service to the eClinical Community.  This particular version is a significant update from the previous version as it incorporates all the many requirements from the EMA Guideline on computerised systems and electronic data in clinical trials (Effective Sept 2023).

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 around the globe. 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 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 eCF Requirements V2024 is released to eClinical Forum members only, with the V2023.3 now being released to the public. 

Release of PR2023.3 eCF Requirements Document for Public Use

The PR2023.3 document (mapped to 38 regulatory documents) is being released to the public as we believe that it will be of significant use to all:  Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) (eclinicalforum.org)

The eCF has also produced an assessment tool, 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 tool is called “eSRA” for “eSource-Readiness Assessment” and can be downloaded from the eClinical Forum website in the Site Sys Assmts tab: Site Sys Assmts (eclinicalforum.org) 

A sister assessment tool, also based on the eCF Requirements can be used to assess if a site’s file system (called “Investigator Site File System” (ISF) or “Site Trial Master System” (STMF) can also be downloaded for free from Site Sys Assmts (eclinicalforum.org)

AND! We will be running a free webinar to provide information on how these tools are developed and maintained and how companies are using them. Please register! We will be offering it at 2 times as well as recording and registration is necessary to gain access to either (we promise we will not use your email for anything other than to provide you with information on these free tools and webinar):  eCF Public Webinar Sept 2024 (eclinicalforum.org)

To register for this free webinar, please follow this link:    eCF Public Webinar Sept 2024 (eclinicalforum.org)

 

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