Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers

  • Title: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
  • Description: 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 records and electronic signatures in clinical investigations of medical products under 21 CF part 11, Electronic Records; Electronic Signatures.
  • Institution: U.S. Department of Health and Human Services
  • 1645508744688_22 FDA_Guidance_21_CFR_Part_11.pdf (239.8 KB)