FDA Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations under Part 11 – Q&A, 6/17

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In June, 2017, the CDER, CBER, and CDRH branches of the FDA published Draft Guidance for Industry, Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11 – Questions and Answers.  This draft document is intended to provide guidance to study sponsors, investigators, institutional review boards (IRBs), and contract research organizations (CROs) 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 document acknowledges technological advances since 21 CFR Part 11 went into effect in 1997 and provides compliance guidance within the context of the current technological environment.

Examples of electronic systems used in clinical investigations include electronic case report forms (eCRFs), electronic data capture (EDC) systems, electronic trial master files (eTMFs), electronic Clinical Data Management System (eCDMS), electronic Clinical Trial Management System (eCTMS), Interactive Voice Response System (IVRS), Interactive Web Response System (IWRS), web-based electronic patient-reported outcomes (ePRO) portals, and electronic IRB human subject application systems (eIRBs).

Subjects addressed within this draft guidance document include:

• Risk-based validation approaches
• Auditing and assessing software vendors
• Security safeguards
• Applicability of Part 11 to clinical sites outside the US
• Use of cloud-computing services
• Service agreements with cloud-computing providers
• Mobile technologies
• Biometric user identification
• Electronic signature methods