Draft FDA Guidance on Electronic Records and Electronic Signatures in Clinical Investigations
FDA announced the availability of a draft guidance for industry entitled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11-- Questions and Answers.” The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under 21 CFR part 11 in clinical investigations of medical products.