Part 11 Compliance: Electronic Signatures in Human Subjects Research

Overview

Researchers who create, maintain, and transmit electronic records in connection with human subjects research (including electronic signatures) must comply with the federal and state regulations that govern the use of electronic systems.  When electronic signatures or recordkeeping systems are utilized to support research involving drugs, biologics, and devices regulated by FDA, the research is subject to an additional set of requirements found at 21 C.F.R. Part 11 (often referred to as FDA “Part 11”).

UCSF Validated Electronic Systems

Researchers seeking electronic systems and tools that are already validated as Part 11 compliant for FDA-regulated research at UCSF should review the following:

  • UCSF Institutional Review Board (IRB) FAQ #2 about Part 11 compliant systems that can be used to obtain electronic consent, including:
    • DocuSign Part 11 module
    • REDCap Premium
    • Third-party platforms:
      • SecureConsent
      • FDA COVID MyStudies
      • REDCap Cloud
  • The UCSF IRB also clarifies that research that is not subject to FDA regulations can use platforms that are not Part 11 complaint, which are also listed on the IRB website.

NOTE: We have additional legal guidance and practical advice for complying with federal and state requirements for the use of electronic documents and signatures in the research context other than the validated electronic systems above. Please contact FDAConsults@ucsf.edu for assistance.

UCSF's Non-Repudiation Letter

UCSF has a non-repudiation letter on file with the FDA. This statement and letter from UCSF Senior Associate Vice Chancellor - Research, Brian Smith, JD, MBA is posted on the IRB website and may be provided to sponsors if requested: 

UCSF researchers seeking to set up a WebTrader account to enable electronic submissions to FDA can attach the above non-repudiation letter to their email request for a WebTrader account.

FDA Guidance