Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

15 March 2023 – the FDA published draft Q&A guidance on the use of electronic systems, electronic records, and electronic signatures in clinical investigations. Submit comments by 15 May 2023.

This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs.

The guidance provides recommendations regarding the requirements, including the requirements under 21 CFR part 11 (part 11), under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.