Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public Release PR2024

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 8th 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 (V2024 PR) as a service to the eClinical Community.  The V2025, recently released, is available to eClinical Forum members only and includes mappings to ICH E6 R3. For information on becoming an eClinical Forum member, please see our Membership tab on this website. eCF members can receive the V2025 by contacting REG@eClinicalForum.org from their organisation email address.

This is an ongoing effort of the eClinical Forum’s “Regulatory Expert Group” (REG).  They have put in countless hours to ensure that this comprehensive checklist for evaluating electronic systems that will manage data used in regulated clinical research remains up-to-date against regulations and guidance from FDA /United States, EMA/European Union, PMDA/Japan, NMPA/China, MHRA/United Kingdom, TFDA/Taiwan ROC, and ICH (International Council on Harmonization) among others.  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 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 V2025 is released to eClinical Forum members only, with the V2024 now being released to the public.