FDA Announces New Draft Guidance on the Use of Electronic Records

The new draft guidance entitled Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11 — Questions and Answers, “clarifies, updates and expands upon” a draft guidance issued in 2003 and “provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products.” Here is a link to the guidance, and for information on how to comment on it, here is a link to the Federal Register Notice. Contact us for help with your clinical trial protocol.