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”).
For more information about 21 C.F.R. Part 11 at UCSF, please see the Office of Ethics and Compliance Website.