Regulatory Advisory Group (REG)

The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites). For draft documents, comments are submitted to regulatory authorities. Final documents are mapped to 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 unique statements. This is updated annually and released to eCF members. Previous year's "eCF Reqs" are released to the public.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. Each eCF member company may have one representative on the REG team.