FDA new Draft Guidance: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers

For everyone working in or supporting clinical studies this is a worthwhile read.

This draft guidance revises a prior version (Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers (June 2017) and also expands on others and will supersede one when finalized.

From the Introduction:

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.

This guidance expands upon recommendations in the guidance for industry Part 11, Electronic Records; Electronic Signatures — Scope and Application (August 2003) (2003 part 11 guidance) that pertain to clinical investigations conducted under 21 CFR parts 312 and 812.

When finalized, this guidance will supersede the guidance for industry Computerized Systems Used in Clinical Investigations (May 2007).

This draft guidance covers many divisions of the FDA: CDER, CBER, CDRH, CFSAN, CTP, CVM, ORA and OCLiP.

#FDA #21CFRPart11 #DraftGuidanceQ&A #electronicsystems# electronicrecords #electronicsignatures #clinicalstudies

The draft guidance is available here: https://www.fda.gov/media/166215/download