Part 11 Compliance: Electronic Signatures in Human Subjects Research

Questions? Contact Clinical Trials Regulatory Support

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 maintain records for 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

The following electronic systems and tools are validated as Part 11 compliant for FDA-regulated research at UCSF:

Research that is NOT subject to FDA regulations can use platforms that are not Part 11-compliant.

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 [email protected] 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 or ESG NextGen account to enable electronic submissions to the FDA can attach the above non-repudiation letter to their email request for a WebTrader or ESG NextGen account.

FDA Guidance