New FDA Draft Guidance – Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11

The FDA  released a new draft guidance document on 21 June 2017.  Comments should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

>>>Link to Draft Guidance Document: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers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 guidance discusses the following:

  • Procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and that the records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper
  • The use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812

The goals of this guidance are as follows:

  • Update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations
  • Clarify and further expand on the risk-based approach described in the 2003 part 11 uidance to validation, audit trails, and archiving of records
  • Encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations

Submit Feedback to the FDA:

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

Acknowledgements: Prof David Hutchison, www.canarybooks.com

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