Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11-Questions and Answers; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations--Questions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records; Electronic Signatures--Scope and Application'' issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations.