FDA does not mandate or specify any particular methods for electronic signatures,
including any particular biometric method upon which an electronic signature may be
based. Part 11 regulations permit a wide variety of methods to create electronic
signatures, including the use of computer-readable ID cards, biometrics, digital
signatures, and username and password combinations.
When a document is electronically signed, the electronic signature must be accompanied
by a computer-generated, time-stamped audit trail (see §§ 11.10(e) and 11.50(b)). When
study participants provide an electronic signature, clinical investigators should ensure
that the participants understand the legal significance of the signature.