Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments

The eClinical Forum provided a webinar on 18-Sep-2024 to provide information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. These tools are absolutely free to download as a service to the industry that we serve; we do not even collect email or other information.

“eCF Requirements” - The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents (FDA, EMA, PMDA, NMPA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data. Each Requirement has, as its basis, one or more statements from one or more of these regulatory documents. The eCF Requirements can be used to determine if systems are consistent with regulatory requirements, and if systems and process that manage these data have the necessary features.  This set of requirements is the result of countless hours of discussion among regulatory experts from the eClinical Forum member organizations over the past 15 years. It is updated annually.

“eSRA” – The eClinical Forum’s free Investigator Site self-assessment, of the readiness of their healthcare systems to originate data that could be used in a regulated clinical trial, is based on the eCF Requirements and thus each question is grounded on one or more regulatory document statements.  It is easy to access and easy to use and has been used by thousands of sites around the globe and many pharmaceutical sponsors and CROs since it’s launch in 2015. It is updated annually. 

“ISF System Assessment” – A sister assessment to eSRA, this assessment (also free to download from the eCF website), was launched in April 2024 and provides an assessment for sponsors to determine if a site’s Investigator Site File System (or “Site Trial Master System”) is appropriate for holding information for their regulated clinical trial.  It is also based on eCF Requirements/regulatory authority statements. It will be updated annually.

The public version of the eCF Requirements can be downloaded at: Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) (eclinicalforum.org)

The eSRA and ISF Assessments can be downloaded at: https://eclinicalforum.org/site-sys-assmts

To review the 37-min webinar or download the slides, please see below.