Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .
This set of requirements can be downloaded for free from the eCF website and can be of great assistance when developing system specifications, test suites, evaluation checklists and RFIs for systems that are/will be managing data for clinical research. They are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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 … and thus, through using the eCF Requirements you can save countless hours studying all the different regulatory documents.
This work is a result of the vast experience of the eCF 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.
The eCF Requirements V2018PR document (mapped to 14 regulatory documents) can be downloaded from www.eclinicalforum.org in the “Downloads” tab.
The eCF has also produced a free 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 eSRA tab.
At this time, the 2019 Version (mapped to an additional 9 documents) is reserved for eClinical Forum members only. For information on becoming an eClinical Forum member (and thus having access to the eCF Requirements V2019), please see membership details at www.eclinicalforum.org/membership or send us a note at firstname.lastname@example.org and we will be happy to set up a phone meeting to discuss all the benefits that come to an organization through membership.