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


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.

This FDA Draft Guidance when finalized will represent the current thinking of the FDA on this topic.

You can access this guidance by clicking here: FDA Electronic Records and Signatures Guidance.