Description
The use of electronic systems to support critical endpoint and safety data continues to increase. A clinical eSystem is an electronic system used to support the clinical trial, such as to collect, handle, and manage clinical trial data, manage investigational product, or informed consent.
Clinical eSystem is not a regulatory term, but the FDA regulates electronic systems, electronic records, and electronic signatures used to create records required for studies per 21 CFR Part 11. Part 11 is a companion regulation to other FDA regulations and laws called “predicate rules,” where specific requirements for recordkeeping, record content, signatures, and record retention are addressed. Part 11 is complex, and guidance documents have been published for sponsors and CROs to understand how to maintain compliance. Sponsor oversight of the electronic systems used by CROs and sites is not only a best practice to ensure quality data and participant safety but also is a regulatory requirement.
