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GUIDANCE DOCUMENT

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Draft Guidance for Industry June 2017

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

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 CFR part 11, Electronic Records; Electronic Signatures.

This guidance clarifies, updates, and expands upon recommendations in the guidance for  industry Part 11, Electronic Records; Electronic Signatures – Scope and Application (referred to as the 2003 part 11 guidance) that pertain to clinical investigations conducted under 21 CFR parts 312 and 812. Thus, this guidance is limited to outlining the scope and application of part 11 requirements for clinical investigations of medical products.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.